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Anand E, Pelly T, Joshi S, Shakweh E, Hanna LN, Hart A, Tozer P, Lung P. Current practice and innovations in diagnosing perianal fistulizing Crohn's disease (pfCD): a narrative review. Tech Coloproctol 2025; 29:102. [PMID: 40232330 PMCID: PMC12000175 DOI: 10.1007/s10151-025-03122-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/09/2024] [Accepted: 02/23/2025] [Indexed: 04/16/2025]
Abstract
Perianal fistulizing Crohn's disease (pfCD) represents a severe manifestation of Crohn's disease (CD) that often leads to significant morbidity. Clinical examination alone of perianal fistulae is unlikely to be sufficient in the context of complex pfCD, as patients are likely to have complex disease and are more likely to experience complications, treatment failure, and recurrent disease. Furthermore, the relapsing-remitting nature of Crohn's disease and our limited understanding of the pathogenesis of this potentially destructive disease necessitate regular examination and radiological assessment, often in the form of magnetic resonance imaging (MRI). Recent advancements in diagnostic techniques have enhanced the accuracy and timeliness of pfCD diagnosis, facilitating better patient outcomes. A growing appreciation of isolated perianal Crohn's disease has prompted a recent attempt to develop consensus recommendations on diagnosing and treating this group of patients who would previously not have been offered CD medications. This narrative review aims to summarize current practice and the latest developments in the diagnosis of pfCD, highlighting: 1. Clinical examination and assessment tools 2. Current imaging practices 3. Innovations in imaging and biomarkers 4. The diagnosis of isolated perianal Crohn's disease.
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Affiliation(s)
- E Anand
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK.
- Imperial College London, London, UK.
| | - T Pelly
- Imperial College London, London, UK
| | - S Joshi
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK
- Imperial College London, London, UK
| | - E Shakweh
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK
- Imperial College London, London, UK
| | - L N Hanna
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK
- Imperial College London, London, UK
| | - A Hart
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK
- Imperial College London, London, UK
| | - P Tozer
- St Mark's The National Bowel Hospital, Central Middlesex, Acton Lane, London, UK
- Imperial College London, London, UK
| | - P Lung
- Imperial College London, London, UK
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Anand E, Devi J, Ballard DH, Joshi S, Tozer P, Hart A, Antoniou A, Deepak P, Stoker J, Lung P. Defining Radiological Healing in Perianal Fistulizing Crohn's Disease: a TOpClass Global Expert Delphi Consensus. Clin Gastroenterol Hepatol 2025:S1542-3565(25)00248-4. [PMID: 40210078 DOI: 10.1016/j.cgh.2025.02.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2024] [Revised: 02/25/2025] [Accepted: 02/26/2025] [Indexed: 04/12/2025]
Abstract
BACKGROUND & AIMS Perianal fistulising Crohn's disease (pfCD) affects one-fifth of patients with Crohn's disease (CD), significantly affecting their quality of life. Magnetic resonance imaging is the gold standard for evaluating fistula healing in pfCD, but variability in radiological definitions hampers meaningful clinical interpretation and consistent trial design. This study aimed to establish an international consensus on the definition of radiological healing in pfCD. METHODS The study was conducted in 2 phases. Phase 1 involved a systematic review to identify magnetic resonance imaging-based variables and indices used to define healing in pfCD, assessing methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework. Phase 2 utilized a 2-round online Delphi consensus process with 84 international experts, followed by a stakeholder meeting to achieve consensus (agreement threshold >80%). Results were reported as per Accurate Consensus Reporting Document (ACCORD) guidelines. RESULTS A radiologically healed fistula can be defined by the absence of T2-weighted hyperintensity, a completely fibrotic fistula tract and, when contrast is used, the absence of contrast enhancement on post-contrast T1-weighted images (95% consensus). Radiological improvement of a fistula can be defined (80% consensus) by the presence of a least one essential criterion: an increasingly fibrotic fistula tract, an unequivocal reduction in one or more of the following: T2-weighted hyperintensity, fistula diameter, fistula length, abscess size, or contrast enhancement of the fistula tract. CONCLUSION This international Delphi consensus standardizes radiological endpoints in pfCD, improving consistency in clinical and research settings. Future studies will validate this definition and assess how radiological changes predict long-term clinical outcomes and quality of life improvements.
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Affiliation(s)
- Easan Anand
- Imperial College London, London, United Kingdom; St Mark's The National Bowel Hospital, Harrow, United Kingdom.
| | - Jalpa Devi
- Washington University School of Medicine in St Louis, St Louis, Missouri
| | - David H Ballard
- Washington University School of Medicine in St Louis, St Louis, Missouri
| | - Shivani Joshi
- Imperial College London, London, United Kingdom; St Mark's The National Bowel Hospital, Harrow, United Kingdom
| | - Phil Tozer
- Imperial College London, London, United Kingdom; St Mark's The National Bowel Hospital, Harrow, United Kingdom
| | - Ailsa Hart
- Imperial College London, London, United Kingdom; St Mark's The National Bowel Hospital, Harrow, United Kingdom
| | | | - Parakkal Deepak
- Washington University School of Medicine in St Louis, St Louis, Missouri
| | - Jaap Stoker
- Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, The Netherlands
| | - Phillip Lung
- Imperial College London, London, United Kingdom; St Mark's The National Bowel Hospital, Harrow, United Kingdom
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Debnath P, Acord MR, Anton CG, Courtier J, El-Ali AM, Forbes-Amrhein MM, Gee MS, Greer MLC, Guillerman RP, Kocaoglu M, Lala SV, Rees MA, Schooler GR, Towbin AJ, Zhang B, Frischer JS, Minar P, Dillman JR. Magnetic resonance imaging for suspected perianal Crohn's disease in children: a multi-reader agreement study. Eur Radiol 2025:10.1007/s00330-025-11469-5. [PMID: 40121591 DOI: 10.1007/s00330-025-11469-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2024] [Revised: 01/06/2025] [Accepted: 01/29/2025] [Indexed: 03/25/2025]
Abstract
OBJECTIVES We aimed to assess inter-radiologist agreement when interpreting pelvic MRI in children with newly diagnosed perianal Crohn's disease (CD). MATERIALS AND METHODS In this retrospective multi-reader study, we identified pediatric patients (< 18 years of age) who underwent a pelvic MRI examination for newly diagnosed perianal CD. Images were de-identified and uploaded to a cloud-based image platform for review by 13 fellowship-trained pediatric radiologists The reviewers assessed for the presence of a fistula and abscess, categorization of different imaging findings, and classification using the Parks and St James' University Hospital systems. Fleiss' kappa (κ) statistics and intra-class correlation coefficients (ICC) were used to measure inter-reader agreement, along with 95% confidence intervals (CI). RESULTS Forty-six patients were included in our study (median age = 13.0 years [IQR: 10.5 to 16.0 years]); thirty-five (76.1%) were boys. Most imaging features showed fair agreement (κ = 0.21 to 0.35). There was moderate agreement for categorical fistula length (κ = 0.42 [95% CI: 0.32 to 0.53]), involvement of the genitalia (κ = 0.45 [95% CI: 0.26 to 0.63]), and presence of an abscess/collection (κ = 0.52 [95% CI: 0.31 to 0.73]). Maximum abscess/collection length had good agreement (ICC = 0.81 [95% CI: 0.41, 1.00]). There was an almost equal split (yes vs. no: 50.7% vs. 49.3%) regarding whether postcontrast T1-weighted images added value compared to T2-weighted images alone across all radiologists and examinations. CONCLUSION Inter-radiologist agreement when interpreting pelvic MRI for perianal CD in children is fair for most imaging features, with fewer features demonstrating moderate or good agreement. KEY POINTS Question Pelvic magnetic resonance imaging (MRI) is used for diagnosing and monitoring children with perianal Crohn's disease (CD). Limited information is known about inter-radiologist agreement. Findings Agreement between pediatric radiologists when interpreting MRI for perianal CD in children is only fair for most imaging features (κ = 0.21 to 0.35). Clinical relevance Understanding MRI inter-radiologist agreement is crucial to improve the reliability of pelvic MRI in children with perianal Crohn's disease since it may affect patient management (e.g., surgery); further radiologist education and improved imaging feature definitions may help improve inter-radiologist agreement.
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Affiliation(s)
- Pradipta Debnath
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
| | - Michael R Acord
- Department of Radiology, Children's Hospital of Philadelphia, Philadelphia, PA, USA
| | - Christopher G Anton
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Jesse Courtier
- Department of Radiology and Biomedical Imaging, Benioff Children's Hospital, San Francisco, CA, USA
| | | | - Monica M Forbes-Amrhein
- Department of Radiology and Imaging Sciences, Riley Hospital for Children, Indianapolis, IN, USA
| | - Michael S Gee
- Division of Pediatric Imaging, Department of Radiology, Massachusetts General Hospital, Boston, MA, USA
| | - Mary-Louise C Greer
- Department of Diagnostic and Interventional Radiology, The Hospital for Sick Children, Department of Medical Imaging, University of Toronto, Toronto, Ontario, Canada
| | - R Paul Guillerman
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Murat Kocaoglu
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Shailee V Lala
- Department of Radiology, NYU Langone Health, New York, NY, USA
| | - Mitchell A Rees
- Department of Radiology, Nationwide Children's Hospital, Columbus, OH, USA
| | - Gary R Schooler
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Alexander J Towbin
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Bin Zhang
- Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
- Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA
| | - Jason S Frischer
- Colorectal Center, Division of Pediatric General and Thoracic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
| | - Phillip Minar
- Division of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA
| | - Jonathan R Dillman
- Department of Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
- Department of Radiology, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
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Beek KJ, Mulders LGM, van Rijn KL, Horsthuis K, Tielbeek JAW, Buskens CJ, D'Haens GR, Gecse KB, Stoker J. External validation of the MAGNIFI-CD index in patients with complex perianal fistulising Crohn's disease. Eur Radiol 2025; 35:1428-1439. [PMID: 39212672 PMCID: PMC11836172 DOI: 10.1007/s00330-024-11029-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2024] [Revised: 06/14/2024] [Accepted: 07/23/2024] [Indexed: 09/04/2024]
Abstract
BACKGROUND There is an increasing need for objective treatment monitoring in perianal fistulising Crohn's disease (pfCD). Therefore, the magnetic resonance novel index for fistula imaging in CD (MAGNIFI-CD) index has been designed and internally validated on the ADMIRE-CD trial cohort. The aim of this study was to externally validate the MAGNIFI-CD index to monitor response to medical and surgical treatment regimens in pfCD. METHODS A retrospective longitudinal cohort was established of consecutive patients with complex pfCD treated with surgical and/or medical therapy and a baseline and follow-up MRI between January 2007 and May 2021. The MAGNIFI-CD index was scored by two independent, abdominal radiologists blinded for time points and clinical outcomes. Responsiveness, reliability, and test accuracy regarding clinically important improvement were assessed. Cut-offs for response and remission were selected classified on fistula drainage assessment and physician global assessment. RESULTS A total of 65 patients (51% female, median age 32 years) were included. A clinically relevant responsiveness of the MAGNIFI-CD was shown, with a significant decrease in clinical remitters and responders with a median MAGNIFI-CD of 18.0 [7.5-20.0] to 9.0 [0.8-16.0] (p < 0.001) and non-significant change in non-responders with a median MAGNIFI-CD of 20.0 [12.0-23.0] to 18.0 [13.0-21.0] (p = 0.22). There was an 'almost perfect' interobserver agreement (ICC = 0.87; 95% CI 0.80-0.92) for the MAGNIFI-CD index. An optimal cut-off value was defined as a decrease of 2 points for clinical response, and a MAGNIFI-CD ≤ 6 for remission at follow-up MRI. CONCLUSION The MAGNIFI-CD index is a responsive and reliable MRI scoring instrument for treatment monitoring in perianal fistulising Crohn's disease. CLINICAL RELEVANCE STATEMENT The MAGNIFI-CD index is a well-structured, responsive scoring instrument to assess fistula severity and activity that allows quantitative detection of changes in therapy response in patients with perianal fistulising Crohn's disease, thereby facilitating endpoints in clinical trials. KEY POINTS Well-defined cut-offs for response and remission are needed for objective treatment monitoring of perianal fistulising Crohn's disease (pfCD). Cut-off values for remission and for response at 6 months follow-up were defined. Interobserver agreement was good. The MAGNIFI-CD index is responsive and reliable for treatment monitoring and is suitable for use in clinical trials.
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Affiliation(s)
- Kim J Beek
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
| | - Lieven G M Mulders
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
| | - Kyra L van Rijn
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
| | - Karin Horsthuis
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location Vrije Universiteit, De Boelelaan 1117, Amsterdam, The Netherlands
| | - Jeroen A W Tielbeek
- Spaarne Gasthuis, Department of Radiology and Nuclear Medicine, Boerhaavelaan 22, Haarlem, The Netherlands
| | - Christianne J Buskens
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
- Department of Surgery, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
| | - Geert R D'Haens
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
| | - Krisztina B Gecse
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, Location University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.
- Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands.
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Cao D, Wang X, Zhang Y, Qian K, Yang N, Zhu M, Li Y, Wu G, Cui Z. Total fistula volume predicts surgical outcomes in complex perianal fistulizing Crohn's disease following fistula-tract laser closure: a single-center retrospective study. Tech Coloproctol 2025; 29:70. [PMID: 39961900 PMCID: PMC11832601 DOI: 10.1007/s10151-024-03094-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2024] [Accepted: 12/22/2024] [Indexed: 02/20/2025]
Abstract
BACKGROUNDS This study aimed to identify risk factors influencing long-term treatment outcomes in patients with complex perianal fistulizing Crohn's disease (pfCD) following fistula-tract laser closure (FiLaC™). METHODS A retrospective analysis was conducted on data from patients with complex pfCD who underwent FiLaC™ from January 2019 to December 2020, including demographics, pharmacological regimens, and preoperative MRI assessments. Follow-up monitored fistula outcomes such as healing, remission, failure, and recurrence. RESULTS Among 49 patients followed for an average of 60.0 months, 31 (63.3%) achieved fistula healing, 3 (6.1%) showed improvement, 3 (6.1%) had non-healing, and 12 (24.5%) experienced recurrence. Significant differences were found between healed and unhealed groups in total fistula volume (TFV), number of fistula tracts, and perianal Crohn's disease activity index (PDAI) (P = 0.036, P = 0.020, and P = 0.041, respectively). Multivariate regression analysis indicated TFV as a significant predictor of healing outcomes (P = 0.013). ROC analysis confirmed its predictive value for fistula healing in complex pfCD, with an area under the curve (AUC) of 0.729 (P = 0.008). The optimal threshold for TFV was 4.81 cm3, with a sensitivity of 61.1% and a specificity of 83.9%. The AUC for recurrence rates was 0.883 (P < 0.001), with sensitivity and specificity at 83.3% and 83.8%, respectively, using the same threshold for TFV. The Kaplan-Meier survival curve highlighted the predictive potential of TFV for fistula recurrence (P < 0.0001). CONCLUSIONS TFV is an effective predictor of long-term outcomes in patients with complex pfCD following FiLaC™.
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Affiliation(s)
- D Cao
- Department of General Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Baoshan Branch, Shanghai, 200444, China
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
| | - X Wang
- Department of General Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Baoshan Branch, Shanghai, 200444, China
| | - Y Zhang
- Laboratory of Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Baoshan Branch, Shanghai, 200444, China
| | - K Qian
- Laboratory of Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Baoshan Branch, Shanghai, 200444, China
| | - N Yang
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
| | - M Zhu
- Division of Gastroenterology and Hepatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
| | - Y Li
- Department of General Surgery, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, 639 Zhizaoju Road, Shanghai, 200011, China.
| | - G Wu
- Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200444, China.
| | - Z Cui
- Department of General Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Baoshan Branch, Shanghai, 200444, China.
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.
- Institute of Translational Medicine, Shanghai University, Shanghai, 200444, China.
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Arkenbosch JHC, van Ruler O, de Vries AC, van der Woude CJ, Dwarkasing RS. The role of MRI in perianal fistulizing disease: diagnostic imaging and classification systems to monitor disease activity. Abdom Radiol (NY) 2025; 50:589-597. [PMID: 39180667 PMCID: PMC11794340 DOI: 10.1007/s00261-024-04455-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/03/2024] [Revised: 06/12/2024] [Accepted: 06/15/2024] [Indexed: 08/26/2024]
Abstract
Perianal fistulizing disease, commonly associated with Crohn's disease, poses significant diagnostic and therapeutic challenges due to its complex anatomy and high recurrence rates. Radiological imaging plays a pivotal role in the accurate diagnosis, classification, and management of this condition. This article reviews the current radiological modalities employed in the evaluation of perianal fistulizing disease, including magnetic resonance imaging (MRI), endoanal ultrasound, and computed tomography (CT). MRI, recognized as the gold standard, offers superior soft tissue contrast and multiplanar capabilities, facilitating detailed assessment of fistula tracts and associated abscesses. CT, although less detailed than MRI, remains valuable in acute settings for detecting abscesses and guiding drainage procedures. This article discusses the advantages and limitations of each modality, highlights the importance of standardized imaging protocols, and underscores the need for interdisciplinary collaboration in the management of perianal fistulizing disease. Future directions include advancements in imaging techniques and the integration of artificial intelligence to enhance diagnostic accuracy and treatment outcomes.
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Affiliation(s)
- Jeanine H C Arkenbosch
- Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - Oddeke van Ruler
- Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, The Netherlands
| | - Annemarie C de Vries
- Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - C Janneke van der Woude
- Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands
| | - Roy S Dwarkasing
- Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.
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De Gregorio M, Winata LS, Hartley I, Behrenbruch CC, Connor SJ, D‘Souza B, Basnayake C, Guerra GR, Johnston MJ, Kamm MA, Keck JO, Lust M, Niewiadomski O, Ong EJS, Schulberg JD, Srinivasan A, Sutherland T, Woods RJ, Wright EK, Connell WR, Thompson AJ, Ding NS. A new protocolized treatment strategy optimizing medical and surgical care leads to improved healing of Crohn's perianal fistulas. J Crohns Colitis 2025; 19:jjae199. [PMID: 39756400 PMCID: PMC11772862 DOI: 10.1093/ecco-jcc/jjae199] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2024] [Indexed: 01/07/2025]
Abstract
BACKGROUND AND AIMS Crohn's perianal fistula healing rates remain low. We evaluated the efficacy of a protocolized multidisciplinary treatment strategy optimizing care in adults with Crohn's perianal fistulas. METHODS A new treatment strategy was established at a single tertiary center. The strategy comprised 3 dynamic stages of care directed toward achieving and maintaining fistula healing. Stage A, active disease, focused on early commencement and proactive escalation of biologic therapies and structured surgical reviews ensuring adequate fistula drainage and conditioning. Stage B, optimized disease with a seton in situ, focused on consideration for seton removal and appropriateness of definitive surgical closure and/or ablative techniques. Stage C, healed disease, focused on proactive care maintenance. Sixty patients were sequentially enrolled and prospectively followed for ≥12 months. Endpoints included clinical healing and radiologic remission in those with clinically active fistulas, and relapse in those with healed fistulas. RESULTS At baseline, 52% (n = 31) and 48% (n = 29) had clinically active and healed fistulas, respectively. For patients with clinically active fistulas, 71% achieved clinical healing after 22 months, with estimated healing rates of 39% and 84% at 1 and 2 years, respectively. Radiologic remission was achieved in 25%, significantly higher than baseline inclusion rates of 6%. For patients with healed fistulas, 7% experienced clinical relapse after 23 months, with no significant change in radiologic remission, 80% versus 86% at baseline. CONCLUSIONS A protocolized treatment strategy proactively optimizing care resulted in high rates of clinical healing and improved radiologic remission of Crohn's perianal fistulas. Controlled-matched studies are needed.
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Affiliation(s)
- Michael De Gregorio
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Leon S Winata
- Department of Medical Imaging, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Imogen Hartley
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Corina C Behrenbruch
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Susan J Connor
- Department of Gastroenterology, Liverpool Hospital Sydney, Liverpool, New South Wales, Australia
- Department of UNSW Medicine & Health, UNSW Sydney, South West Sydney Clinical Campuses, Sydney, New South Wales, Australia
| | - Basil D‘Souza
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
- Department of Colorectal Surgery, Northern Hospital, Epping, Victoria, Australia
| | - Chamara Basnayake
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Glen R Guerra
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Surgery, University of Melbourne, Melbourne, Victoria, Australia
| | - Michael J Johnston
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Michael A Kamm
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - James O Keck
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Mark Lust
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Ola Niewiadomski
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Eugene J S Ong
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Julien D Schulberg
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Ashish Srinivasan
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
- Department of Gastroenterology, Austin Health, Heidelberg, Victoria, Australia
- Department of Gastroenterology, Eastern Health, Box Hill, Victoria, Australia
| | - Tom Sutherland
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
- Department of Medical Imaging, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Rodney J Woods
- Department of Colorectal Surgery, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Emily K Wright
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - William R Connell
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
| | - Alexander J Thompson
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
| | - Nik S Ding
- Department of Gastroenterology, St Vincent’s Hospital Melbourne, Fitzroy, Victoria, Australia
- Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
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Bacsur P, Shaham D, Serclova Z, Resál T, Farkas B, Sarlós P, Miheller P, Maharshak N, Zemel M, Shitrit AB, Yellinek S, Bálint A, Fábián A, Bor R, Bősze Z, Ivány E, Szepes Z, Farkas K, Tóth I, Lázár G, Vlkova K, Tremerova A, Zuskova P, Ábrahám S, Molnár T. Evaluation of the Effectiveness and Safety of Mesenchymal Stem Cell Treatment in Fistulising Crohn's Disease: An International Real-Life Retrospective Multicentre Cohort Study. Aliment Pharmacol Ther 2025; 61:335-345. [PMID: 39468719 PMCID: PMC11671715 DOI: 10.1111/apt.18359] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2024] [Revised: 07/15/2024] [Accepted: 10/13/2024] [Indexed: 10/30/2024]
Abstract
BACKGROUND Perianal fistulas of Crohn's disease (CD) create a significant burden on patients' lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. AIMS To examine the usability of darvadstrocel therapy in managing perianal CD. METHODS We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (≥ 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. RESULTS Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. CONCLUSION Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients' satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.
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Affiliation(s)
- Péter Bacsur
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
- HCEMM‐USZ Translational Colorectal Research GroupSzegedHungary
| | - Daniel Shaham
- IBD Unit, Tel Aviv Medical Center, Affiliated to the Faculty of MedicineTel Aviv UniversityTel AvivIsrael
| | - Zuzana Serclova
- Surgical DepartmentClinical IBD Center ISCAREPragueCzech Republic
- Surgical DepartmentUniversity Hospital Kralovske VinohradyPragueCzech Republic
| | - Tamás Resál
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Bernadett Farkas
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Patrícia Sarlós
- Division of Gastroenterology, First Department of Medicine, Medical SchoolUniversity of PécsPécsHungary
| | - Pál Miheller
- Department of Surgery, Transplantation and Gastroenterology, Faculty of MedicineSemmelweis UniversityBudapestHungary
| | - Nitsan Maharshak
- IBD Unit, Tel Aviv Medical Center, Affiliated to the Faculty of MedicineTel Aviv UniversityTel AvivIsrael
| | - Meir Zemel
- Colorectal Unit, Surgical Division, Tel Aviv Medical Center, Affiliated to the Faculty of MedicineTel Aviv UniversityTel AvivIsrael
| | - Ariella Bar‐Gil Shitrit
- Digestive Diseases Institute–IBD‐MOM Unit, Shaare Zedek Medical CenterHebrew UniversityJerusalemIsrael
| | - Shlomo Yellinek
- Department of General Surgery, Shaare Zedek Medical CenterThe Hebrew University School of MedicineJerusalemIsrael
| | - Anita Bálint
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Anna Fábián
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Renáta Bor
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Zsófia Bősze
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Emese Ivány
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Zoltán Szepes
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Klaudia Farkas
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
- HCEMM‐USZ Translational Colorectal Research GroupSzegedHungary
| | - Illés Tóth
- Department of Surgery, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - György Lázár
- Department of Surgery, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Katerina Vlkova
- Surgical DepartmentClinical IBD Center ISCAREPragueCzech Republic
| | - Aneta Tremerova
- Surgical DepartmentClinical IBD Center ISCAREPragueCzech Republic
- Surgical DepartmentUniversity Hospital Kralovske VinohradyPragueCzech Republic
| | - Petra Zuskova
- Surgical DepartmentClinical IBD Center ISCAREPragueCzech Republic
- Surgical DepartmentUniversity Hospital Kralovske VinohradyPragueCzech Republic
| | - Szabolcs Ábrahám
- Department of Surgery, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
| | - Tamás Molnár
- Department of Medicine, Albert Szent‐Györgyi Medical SchoolUniversity of SzegedSzegedHungary
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Dawka S, Yagnik VD, Kaur B, Menon GR, Garg P. Garg scoring system to predict long-term healing in cryptoglandular anal fistulas: a prospective validation study. Ann Coloproctol 2024; 40:490-497. [PMID: 36217811 PMCID: PMC11532377 DOI: 10.3393/ac.2022.00346.0049] [Citation(s) in RCA: 4] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2022] [Revised: 06/24/2022] [Accepted: 06/24/2022] [Indexed: 12/24/2022] Open
Abstract
PURPOSE Complex anal fistulas can recur after clinical healing, even after a long interval which leads to significant anxiety. Also, ascertaining the efficacy of any new treatment procedure becomes difficult and takes several years. We prospectively analyzed the validity of Garg scoring system (GSS) to predict long-term fistula healing. METHODS In patients operated for cryptoglandular anal fistulas, magnetic resonance imaging was performed preoperatively and at 3 months postoperatively to assess fistula healing. Scores as per the GSS were calculated for each patient at 3 months postoperatively and correlated with long-term healing to check the accuracy of the scoring system. RESULTS Fifty-seven patients were enrolled, but 50 were finally included (7 were excluded). These 50 patients (age, 41.2±12.4 years; 46 men) were followed up for 12 to 20 months (median, 17 months). Forty-seven patients (94.0%) had complex fistulas, 28 (56.0%) had recurrent fistulas, 48 (96.0%) had multiple tracts, 20 (40.0%) had horseshoe tracts, 15 (32.0%) had associated abscesses, 5 (10.0%) were suprasphincteric, and 8 (16.0%) were supralevator fistulas. The GSS could accurately predict long-term healing (high positive predictive value, 31 of 31 [100%]) but was not very accurate in predicting nonhealing (negative predictive value, 15 of 19 [78.9%]). The sensitivity in predicting healing was 31 of 35 (88.6%). CONCLUSION GSS accurately predicts long-term fistula with a high positive predictive value (100%) but is less accurate in predicting nonhealing. This scoring system can help allay anxiety in patients and facilitate the early validation of innovative procedures for anal fistulas.
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Affiliation(s)
- Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive, Mauritius
| | - Vipul D. Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Center, Patan, India
- Department of Surgery, Banas Medical College and Research Institute, Palanpur, India
| | - Baljit Kaur
- Department of Radiology, SSRD Magnetic Resonance Imaging Institute, Chandigarh, India
| | - Geetha R. Menon
- Department of National Statistics, Indian Council of Medical Research, New Delhi, India
| | - Pankaj Garg
- Department of Colorectal Surgery, Indus Super Specialty Hospital, Mohali, India
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula, India
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10
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Richard N, Derinck A, Bridoux V, Charpentier C, Savoye Collet C, Savoye G. Which magnetic resonance imaging feature is associated with treatment response in perianal fistulizing Crohn's disease? Abdom Radiol (NY) 2024; 49:2913-2920. [PMID: 38512515 DOI: 10.1007/s00261-024-04238-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/10/2023] [Revised: 01/31/2024] [Accepted: 02/05/2024] [Indexed: 03/23/2024]
Abstract
PURPOSE Perianal fistulae are disabling complications of Crohn's Disease. Magnetic resonance imaging features could predict treatment response. This study aimed to determine which magnetic resonance imaging features were predictive of long-term clinical outcome in real life. METHODS Consecutive patients with magnetic resonance imaging performed in a tertiary center were retrospectively analyzed. Clinical outcome was defined as a need for surgical drainage of perianal fistulae or hospitalization. Clinical data and magnetic resonance imaging features (MAGNIFI-CD and Van Assche indices, degree of fibrosis) were studied. RESULTS Fifty-two patients were included between 2016 and 2019 with a mean follow-up of 38 months [29;48]. A higher MAGNIFI-CD index (17/25 versus 11/25; p < 0.01) was associated with an unfavorable long-term clinical outcome. The MAGNIFI-CD index showed an area under the curve of 0.74 (p = 0.006) to predict the clinical outcome of perianal Crohn's disease, compared to 0.67 (p < 0.05) for the Van Assche index. At a threshold of 13 for the MAGNIFI-CD index, sensitivity was 75% (CI95% [59%; 86%]) and specificity was 69% (CI95% [44%; 86%]). No association was found between the degree of fibrosis and clinical outcome, but the association of a high degree of fibrosis (≥ 80%) and of a low MAGNIFI-CD index (≤ 13) was predictive of clinical outcome (p < 0.01). CONCLUSION The MAGNIFI-CD index could be used to predict clinical outcome in perianal Crohn's disease. In combination with a high degree of fibrosis, a low MAGNIFI-CD index, may help to identify patients with the best prognosis.
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Affiliation(s)
- Nicolas Richard
- Department of Gastroenterology, CHU Rouen, INSERM, ADEN UMR1073, Nutrition, Inflammation and microbiota-gut-brain axis, Univ Rouen Normandie, 76000, Rouen, France.
| | | | - Valérie Bridoux
- Department of Digestive Surgery, CHU Rouen, 76000, Rouen, France
| | | | - Céline Savoye Collet
- Department of Radiology, CHU Rouen, QUANTIF-LITIS EA 4108, Univ Rouen Normandie, 76000, Rouen, France
| | - Guillaume Savoye
- Department of Gastroenterology, CHU Rouen, INSERM, ADEN UMR1073, Nutrition, Inflammation and microbiota-gut-brain axis, Univ Rouen Normandie, 76000, Rouen, France
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11
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Cao D, Wang X, Qian K, Yang N, Xu K, Xu G, Zhu M, Zhang Y, Cui Z. Long-term outcomes of fistula-tract laser closure for complex perianal fistulizing Crohn's disease. Tech Coloproctol 2024; 28:89. [PMID: 39085710 DOI: 10.1007/s10151-024-02949-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/02/2023] [Accepted: 05/25/2024] [Indexed: 08/02/2024]
Abstract
BACKGROUND Fistula-tract laser closure (FiLaC™) has shown promising outcomes in perianal fistulizing Crohn's disease (pfCD). However, most studies assessed a mixed cohort encompassing pfCD and cryptoglandular fistulas during a short follow-up period. This study aimed to evaluate the long-term treatment outcomes of FiLaC™ in patients with complex pfCD. METHODS Data from patients with complex pfCD who underwent FiLaC™ during deep remission of Crohn's disease between January 2019 and December 2020 were retrospectively analyzed. Patient demographics, surgery history, and medication strategy were registered before surgery. Follow-ups were scheduled at 1, 2, and 3 months after FiLaC™, and at 2-month intervals thereafter. The primary endpoint was clinic healing, while clinic remission/unhealed/recurrence were classified as unhealed. Additionally, adverse events and Wexner fecal incontinence score were documented. RESULTS Forty-nine patients (40 men and 9 women) with a median age of 26.0 (19.0-35.5) years were included with a median follow-up of 50.0 (39.5-54.0) months. Of these, 31 (63.3%) patients achieved fistula healing, 3 (6.1%) experienced improvement, 3 (6.1%) remained unhealed, and 12 (24.5%) experienced recurrence. Montreal A category was lower in the healed group (P < 0.001). No major complications, such as bleeding or fecal or urinary incontinence, were observed, and pain was transient. The Wexner incontinence score decreased significantly at the last available follow-up, indicating an intact postoperative continence function (P = 0.014). PCDAI scores were significantly higher in the unhealed group (P = 0.041). CONCLUSION FiLaC™ is an efficient and safe sphincter-saving procedure for patients with complex pfCD.
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Affiliation(s)
- D Cao
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
- Department of General Surgery, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200444, China
| | - X Wang
- Department of General Surgery, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200444, China
| | - K Qian
- Laboratory Medicine, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, No.1058, Huan Zhen Bei Rd, Baoshan District, Shanghai, 200444, China
| | - N Yang
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
| | - K Xu
- Institute of Translational Medicine, Shanghai University, Shanghai, 200444, China
- Organoid Research Center, Shanghai University, Shanghai, 200444, China
- Wenzhou Institute of Shanghai University, Wenzhou, 325000, China
| | - G Xu
- Laboratory Medicine, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, No.1058, Huan Zhen Bei Rd, Baoshan District, Shanghai, 200444, China
| | - M Zhu
- Division of Gastroenterology and Hepatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China
| | - Y Zhang
- Laboratory Medicine, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, No.1058, Huan Zhen Bei Rd, Baoshan District, Shanghai, 200444, China.
| | - Z Cui
- Department of Gastrointestinal Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200127, China.
- Department of General Surgery, Baoshan Branch, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200444, China.
- Institute of Translational Medicine, Shanghai University, Shanghai, 200444, China.
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12
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Khan SZ, Arline A, Williams KM, Lee MJ, Steinhagen E, Stein SL. The use of core descriptors from the ENiGMA code study in recent literature: a systematic review. Colorectal Dis 2024; 26:428-438. [PMID: 38296841 DOI: 10.1111/codi.16893] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2023] [Accepted: 01/10/2024] [Indexed: 02/02/2024]
Abstract
AIM The heterogeneity in data quality presented in studies regarding Crohn's anal fistula (CAF) limit extrapolation into clinical practice. The ENiGMA collaborators established a core descriptor set to standardize reporting of CAF. The aim of this work was to quantify the use of these descriptors in recent literature. METHOD We completed a systematic review of PubMed and the Cochrane Library, extracting publications from the past 10 years specific to the clinical interventions and outcomes of CAF, and reported in line with PRISMA guidance. Each article was assessed for inclusion of ENiGMA descriptors. The median number of descriptors per publication was evaluated along with the overall frequency of each individual descriptor. Use of ENiGMA descriptors was compared between medical and procedural publications. RESULTS Ninety publications were included. The median number of descriptors was 15 of 37; 16 descriptors were used in over half of the publications while 17 were used in fewer than a third. Descriptors were more frequently used in procedural (n = 16) than medical publications (n = 14) (p = 0.031). In procedural publications, eight descriptors were more frequently used including Faecal incontinence, Number of previous fistula interventions, Presence and severity of anorectal stenosis and Current proctitis. Medical publications were more likely to include Previous response to biological therapy and Duration and type of current course of biological therapy. CONCLUSION With many descriptors being used infrequently and variations between medical and procedural literature, the colorectal community should assess the need for all 37 descriptors.
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Affiliation(s)
- Saher-Zahra Khan
- University Hospitals Research in Surgical Outcomes and Effectiveness Center (UH-RISES), Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
- Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, USA
| | - Andrea Arline
- Case Western Reserve University School of Medicine, Cleveland, USA
| | | | - Matthew J Lee
- Academic Directorate of General Surgery, Sheffield Teaching Hospitals NHS FT, Sheffield, UK
- Department of Oncology and Metabolism, The Medical School, University of Sheffield, Sheffield, UK
| | - Emily Steinhagen
- University Hospitals Research in Surgical Outcomes and Effectiveness Center (UH-RISES), Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
- Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, USA
| | - Sharon L Stein
- University Hospitals Research in Surgical Outcomes and Effectiveness Center (UH-RISES), Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA
- Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, USA
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Singh A, Kakkar C, Garg S, Arora K, Midha V, Mahajan R, Virk SS, Jain NP, Singh D, Sood K, Tripathi A, Gupta D, Kaushal IG, Galhotra RD, Saggar K, Sood A. Clinical and magnetic resonance imaging spectrum of complex perianal fistulizing Crohn's disease: A cohort study from northern India. Indian J Gastroenterol 2023; 42:668-676. [PMID: 37548863 DOI: 10.1007/s12664-023-01399-9] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/12/2022] [Accepted: 05/15/2023] [Indexed: 08/08/2023]
Abstract
BACKGROUND Fistulizing perianal Crohn's disease (CD) is a debilitating condition associated with significant morbidity and reduction in the quality of life. Magnetic resonance imaging (MRI) of the pelvis is the preferred imaging modality for the comprehensive assessment of the perianal fistula. There is a paucity of data from India on the MRI spectrum of complex perianal fistula in CD. METHODS A single-centre cross-sectional analysis of patients with fistulizing perianal CD, who underwent pelvic MRI between January 2020 and December 2021, was performed. The clinical (age, sex, disease duration, disease location and behavior, disease activity [Perianal Disease Activity Index, PDAI] and treatment received) and radiological (number and location of fistulae, extensions, number and location of internal and external openings, fistula activity, presence or absence of perianal abscess and associated proctitis) characteristics of complex perianal fistula (defined according to the American Gastroenterological Association classification) were recorded. RESULTS Of total 175 patients with CD who attended the gastroenterology clinic during the study period, 27 (15.42%) (mean age 42±15.5 years, 62.96% females and median disease duration four years) had complex perianal fistula and were included in the analysis. The mean PDAI was 5.48±2.53. The median Van Assche Index was 17 (interquartile range [IQR] 13-19). A majority (96.29%) of the fistulae were trans-sphincteric and four (14.81%) fistulae extended into the supralevator space. All fistulae were active on MRI. Concomitant perianal abscess and proctitis were seen in 59.26% (n=16) and 62.96% (n=17) of patients, respectively. Combination therapy with biologics and antibiotics/immune-suppressants were the most commonly prescribed medical therapy. Six (22.22%) patients underwent combined medical and surgical (non-cutting seton, fistulectomy, fecal diversion) treatment. CONCLUSION The cumulative risk of the development of fistulizing perianal CD in a northern Indian cohort was similar to the western populations. Complex perianal fistulae were predominantly trans-sphincteric and commoner in females. MRI evaluation is pivotal for the delineation of fistula anatomy, assessment of disease extent and activity and the evaluation of concomitant perianal abscess and other complications.
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Affiliation(s)
- Arshdeep Singh
- Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India
| | - Chandan Kakkar
- Department of Radiology and Radiodiagnosis, Dayanand Medical College, Ludhiana, 141 001, India
| | - Shreya Garg
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Kirti Arora
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Vandana Midha
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Ramit Mahajan
- Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India
| | - Satpal Singh Virk
- Department of Gastroenterology Surgery, Dayanand Medical College, Ludhiana, 141 001, India
| | - Narender Pal Jain
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Dharmatma Singh
- Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India
| | - Kriti Sood
- Department of Pediatrics, Government Medical College and Rajindra Hospital, Patiala, 147 001, India
| | - Ashish Tripathi
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Dhruv Gupta
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Ishita Gupta Kaushal
- Department of Internal Medicine, Dayanand Medical College, Ludhiana, 141 001, India
| | - Ritu Dhawan Galhotra
- Department of Radiology and Radiodiagnosis, Dayanand Medical College, Ludhiana, 141 001, India
| | - Kavita Saggar
- Department of Radiology and Radiodiagnosis, Dayanand Medical College, Ludhiana, 141 001, India
| | - Ajit Sood
- Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India.
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14
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Meima - van Praag EM, Becker MA, van Rijn KL, Wasmann KA, Stoker J, D'Haens GR, Ponsioen CY, Gecse KB, Dijkgraaf MG, Spinelli A, Danese S, Bemelman WA, Buskens CJ. Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy alone for Crohn's perianal fistulas (PISA-II): long-term outcomes of an international, multicentre patient preference, randomised controlled trial. EClinicalMedicine 2023; 61:102045. [PMID: 37457118 PMCID: PMC10344824 DOI: 10.1016/j.eclinm.2023.102045] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2023] [Revised: 05/30/2023] [Accepted: 05/30/2023] [Indexed: 07/18/2023] Open
Abstract
Background The PISA-II trial showed that short-term anti-tumour necrosis factor (anti-TNF) therapy followed by surgical closure induces radiological healing of perianal fistulas in patients with Crohn's disease more frequently than anti-TNF therapy alone after 18 months. This study aimed to compare long-term outcomes of both treatment arms. Methods Follow-up data were collected from patients who participated in the PISA-II trial, an international patient preference randomised controlled trial. This multicentre trial was performed in nine hospitals in the Netherlands and one hospital in Italy. Patients with Crohn's disease above the age of 18 years with an active high perianal fistula and a single internal opening were asked to participate. Patients were allocated to anti-TNF therapy (intravenous infliximab, or subcutaneous adalimumab, at the discretion of the gastroenterologist) for one year, or surgical closure combined with 4-months anti-TNF therapy. Patients without a treatment preference were randomised (1:1) using random block randomisation (block sizes of six without stratification), and patients with a treatment preference were treated according to their preferred treatment arm. For the current follow-up study, data were collected until May 2022. Primary outcome was radiological healing on magnetic resonance imaging (MRI), including all participants with a MRI made less than 6 months ago at the time of data collection. Analysis was based on observed data. Findings Between September 14, 2013, and December 7, 2019, 94 patients were enrolled in the trial. Long-term follow-up data were available in 91 patients (36/38 (95%) anti-TNF + surgical closure, 55/56 (98%) anti-TNF). A total of 14/36 (39%) patients in the surgical closure arm were randomly assigned, which was not significantly different in the anti-TNF treatment arm (16/55 (29%) randomly assigned). Median follow-up was 5.7 years (interquartile range (IQR) 5-7). Radiological healing occurred significantly more often after anti-TNF + surgical closure (15/36 = 42% versus 10/55 = 18%; P = 0.014). Clinical closure was comparable (26/36 = 72% versus 34/55 = 62%; P = 0.18) in both groups. However, clinical closure in the surgical group was achieved with less re-interventions 4/26 (= 15%) versus 18/34 (= 53%), including (redo-)surgical closure procedures. Recurrences occurred in 0/25 (0%) patients with radiological healing versus 27/76 (36%) patients with clinical closure, sometime during follow-up. Anti-TNF trough levels were higher in patients with long-term clinical closure in both groups (P = 0.031 and P = 0.014). In 6/11 (55%) patients in the anti-TNF group with available trough levels, recurrences were diagnosed within three months of a drop under 3.5ug/ml. 36 patients stopped anti-TNF, after which 0/14 (0%) patients with radiological healing developed a recurrence and 9/22 (41%) with clinical closure. Self-rated (in)continence was comparable between groups, and 79% (60/76) of patients indicated comparable/improved continence after treatment. Decision-regret analysis showed that all (30/30) anti-TNF + surgical closure patients agreed or strongly agreed that surgery was the right decision versus 78% (36/46) in the anti-TNF arm. All surgical closure patients would go for the same treatment again, whereas this was 89% (41/46) in the anti-TNF arm. Interpretation This study confirmed that surgical closure should be considered in amenable patients with perianal fistulas and Crohn's disease as long-term outcomes were favourable, and that radiological healing should be the aim of treatment as recurrences only occurred in patients without radiological healing. In patients with complete MRI closure, anti-TNF could be safely stopped. Funding None.
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Affiliation(s)
- Elise M. Meima - van Praag
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Marte A.J. Becker
- Tytgat Institute for Liver and Intestinal Research and Department of Gastroenterology & Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
| | - Kyra L. van Rijn
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Karin A.T.G.M. Wasmann
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Geert R.A.M. D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Cyriel Y. Ponsioen
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Krisztina B. Gecse
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Marcel G.W. Dijkgraaf
- Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health, Meibergdreef 9, Amsterdam, the Netherlands
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Willem A. Bemelman
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Christianne J. Buskens
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
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15
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The ENiGMA CODE collaborators. Development of a core descriptor set for Crohn's anal fistula. Colorectal Dis 2023; 25:695-706. [PMID: 36461766 DOI: 10.1111/codi.16440] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2022] [Revised: 09/21/2022] [Accepted: 11/08/2022] [Indexed: 12/04/2022]
Abstract
AIM Crohn's anal fistula (CAF) is a complex condition, with no agreement on which patient characteristics should be routinely reported in studies. The aim of this study was to develop a core descriptor set of key patient characteristics for reporting in all CAF research. METHOD Candidate descriptors were generated from published literature and stakeholder suggestions. Colorectal surgeons, gastroenterologists and specialist nurses in inflammatory bowel disease took part in three rounds of an international modified Delphi process using nine-point Likert scales to rank the importance of descriptors. Feedback was provided between rounds to allow refinement of the next ratings. Patterns in descriptor voting were assessed using principal component analysis (PCA). Resulting PCA groups were used to organize items in rounds two and three. Consensus descriptors were submitted to a patient panel for feedback. Items meeting predetermined thresholds were included in the final set and ratified at the consensus meeting. RESULTS One hundred and thirty three respondents from 22 countries completed round one, of whom 67.0% completed round three. Ninety seven descriptors were rated across three rounds in 11 PCA-based groups. Forty descriptors were shortlisted. The consensus meeting ratified a core descriptor set of 37 descriptors within six domains: fistula anatomy, current disease activity and phenotype, risk factors, medical interventions for CAF, surgical interventions for CAF, and patient symptoms and impact on quality of life. CONCLUSION The core descriptor set proposed for all future CAF research reflects characteristics important to gastroenterologists and surgeons. This might aid transparent reporting in future studies.
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16
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Meima-van Praag EM, van Rijn KL, Wasmann KATGM, Snijder HJ, Stoker J, D'Haens GR, Gecse KB, Gerhards MF, Jansen JM, Dijkgraaf MGW, van der Bilt JDW, Mundt MW, Spinelli A, Danese S, Bemelman WA, Buskens CJ. Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy in the treatment of perianal fistulas in Crohn's disease (PISA-II): a patient preference randomised trial. Lancet Gastroenterol Hepatol 2022; 7:617-626. [PMID: 35427495 DOI: 10.1016/s2468-1253(22)00088-7] [Citation(s) in RCA: 39] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2022] [Revised: 03/07/2022] [Accepted: 03/08/2022] [Indexed: 06/14/2023]
Abstract
BACKGROUND Guidelines on Crohn's perianal fistulas recommend anti-tumour necrosis factor (TNF) treatment and suggest considering surgical closure for patients with surgically amenable disease. However, long-term outcomes following these two strategies have not been directly compared. The aim of this study was to assess radiological healing in patients who received short-term anti-TNF treatment and surgical closure compared with those who received anti-TNF treatment alone. METHODS The PISA-II trial was a multicentre, patient preference study done in nine hospitals in the Netherlands and one hospital in Italy. Adult patients with Crohn's disease and an active high perianal fistula with a single internal opening were eligible for inclusion. After counselling, patients with no treatment preference were randomly assigned (1:1) using random block randomisation (block sizes of six without statification), to 4-month anti-TNF therapy and surgical closure or anti-TNF therapy for 1 year, after seton insertion. Patients with a treatment preference received their preferred therapy. The primary outcome was radiological healing assessed by MRI at 18 months, defined as a complete fibrotic tract or a MAGNIFI-CD (Magnetic Resonance Index for Fistula Imaging in Crohn's Disease) score of 0, assessed according to the intention-to-treat principle. Secondary outcomes included clinical closure, number of patients undergoing surgical reintervention and number of reinterventions, recurrences, and impact on quality of life measured by the Perianal Disease Activity Index (PDAI). Analyses were performed on an intention-to-treat basis and additionally an as-treated analysis for radiological healing and clinical closure. This study was registered at the Dutch Trial Registry, NL7625, and with EudraCT, 2018-002064-15, and is closed to accrual due to completion. FINDINGS Between Sept 14, 2013, and Dec 7, 2019, 94 patients were enrolled onto the trial, of whom 32 (34%) were randomly assigned and 62 (66%) chose a specific treatment. 38 (40%) patients were assigned to the surgical closure group and 56 (60%) patients to the anti-TNF group. At 18 months, radiological healing was significantly more common in the surgical closure group (12 [32%] patients) than in the anti-TNF group (five [9%] patients; p=0·005). By contrast, clinical closure was not significantly different between the two treatment groups (26 [68%] patients in the surgical closure group vs 29 [52%] patients in the anti-TNF group; p=0·076). Significantly fewer patients required a reintervention in the surgical closure group than in the anti-TNF therapy group (five [13%] patients in the surgical closure group, median one reintervention [IQR one to three] vs 24 [43%] patients in the anti-TNF group, median two reinterventions [one to two]; p=0·005). Among patients who reached clinical closure during follow-up, four (14%) of 29 in the surgical closure group and five (16%) of 31 in the anti-TNF therapy group had a recurrence, which occurred only in patients without radiological healing. PDAI was significantly lower in the surgical closure group than in the anti-TNF group after 18 months (p=0·031). Adverse events and serious adverse events were similar in both treatment groups and mostly entailed reinterventions. Ten (11%) patients had side-effects associated with anti-TNF treatment. Two serious adverse events unrelated to study treatment occurred (appendicitis and myocardial infarction). One patient died from a tongue base carcinoma, unrelated to study treatment. INTERPRETATION Short-term anti-TNF treatment combined with surgical closure induces long-term MRI healing more frequently than anti-TNF therapy in patients with Crohn's perianal fistulas. These data suggest that patients with Crohn's perianal fistula amenable for surgical closure should be counselled for this therapeutic approach. FUNDING Netherlands Organisation for Health Research and Development and Broad Medical Research Program.
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Affiliation(s)
- Elise M Meima-van Praag
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Kyra L van Rijn
- Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Karin A T G M Wasmann
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Harmanna J Snijder
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Geert R D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Krisztina B Gecse
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Michael F Gerhards
- Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
| | - Jeroen M Jansen
- Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
| | - Marcel G W Dijkgraaf
- Department of Epidemiology and Data Science, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | | | - Marco W Mundt
- Department of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, Netherlands
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Willem A Bemelman
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands; Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Christianne J Buskens
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
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Iqbal N, Sackitey C, Gupta A, Tolan D, Plumb A, Godfrey E, Grierson C, Williams A, Brown S, Maxwell-Armstrong C, Anderson I, Selinger C, Lobo A, Hart A, Tozer P, Lung P. The development of a minimum dataset for MRI reporting of anorectal fistula: a multi-disciplinary, expert consensus process. Eur Radiol 2022; 32:8306-8316. [PMID: 35732929 DOI: 10.1007/s00330-022-08931-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/07/2022] [Revised: 05/08/2022] [Accepted: 05/30/2022] [Indexed: 11/27/2022]
Abstract
There are a range of sphincter-preserving procedures available to treat anorectal fistula, some of which can be precluded, or rendered more optimal by specific features of fistula anatomy. Magnetic resonance imaging (MRI) is the gold standard modality for assessing anorectal fistula. To maximise clinical utility, the MRI report should accurately describe these clinically relevant features. We aimed to develop a minimum dataset for reporting MRI of anorectal fistula, in order to improve the assessment and management of these patients. A longlist of 70 potential items for the minimum dataset was generated through systematic review of the literature. This longlist was presented to radiologists, surgeons and gastroenterologists in an online survey to understand the features that shape current clinical practice. The longlist and survey results were then presented to an expert consensus panel to generate the final minimum dataset through discussion and anonymous voting. The final minimum dataset details the general characteristics, features of the internal and external openings, path of the fistula through the sphincters and any associated extensions and collections that should be described in all MRI reports for anal fistula. Additional surgical and perianal Crohn's disease subsets were developed to indicate the features that aid decision-making for these patients, in addition to a minimum dataset for the clinical request. This study represents a multi-disciplinary approach to developing a minimum dataset for MRI reporting of anal fistula, highlighting the most important features to report that can assist in clinical decision-making. KEY POINTS: • This paper recommends the minimum features that should be included in all MRI reports for the assessment of anal fistula, including Parks classification, number of tracts, features of the internal and external opening, path of the tract through the sphincters, the presence and features of extensions and collections. • Additional features that aid decision-making for surgery or in the presence of Crohn's disease have been identified. • The items that should be included when requesting an MRI are specified.
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Affiliation(s)
- Nusrat Iqbal
- Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK
| | - Charlene Sackitey
- Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK
| | | | | | | | | | | | - Andrew Williams
- Guy's and St Thomas' Hospital NHS Foundation Trust, London, UK
| | - Steven Brown
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | | | | | | | - Alan Lobo
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | - Ailsa Hart
- Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK
| | - Phil Tozer
- Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK
| | - Phillip Lung
- Robin Phillips' Fistula Research Unit, St Mark's Hospital, London, UK.
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18
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Kucharzik T, Tielbeek J, Carter D, Taylor SA, Tolan D, Wilkens R, Bryant RV, Hoeffel C, De Kock I, Maaser C, Maconi G, Novak K, Rafaelsen SR, Scharitzer M, Spinelli A, Rimola J. ECCO-ESGAR Topical Review on Optimizing Reporting for Cross-Sectional Imaging in Inflammatory Bowel Disease. J Crohns Colitis 2022; 16:523-543. [PMID: 34628504 DOI: 10.1093/ecco-jcc/jjab180] [Citation(s) in RCA: 62] [Impact Index Per Article: 20.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
BACKGROUND AND AIMS The diagnosis and follow up of patients with inflammatory bowel disease [IBD] requires cross-sectional imaging modalities, such as intestinal ultrasound [IUS], magnetic resonance imaging [MRI] and computed tomography [CT]. The quality and homogeneity of medical reporting are crucial to ensure effective communication between specialists and to improve patient care. The current topical review addresses optimized reporting requirements for cross-sectional imaging in IBD. METHODS An expert consensus panel consisting of gastroenterologists, radiologists and surgeons convened by the ECCO in collaboration with ESGAR performed a systematic literature review covering the reporting aspects of MRI, CT, IUS, endoanal ultrasonography and transperineal ultrasonography in IBD. Practice position statements were developed utilizing a Delphi methodology incorporating two consecutive rounds. Current practice positions were set when ≥80% of the participants agreed on a recommendation. RESULTS Twenty-five practice positions were developed, establishing standard terminology for optimal reporting in cross-sectional imaging. Assessment of inflammation, complications and imaging of perianal CD are outlined. The minimum requirements of a standardized report, including a list of essential reporting items, have been defined. CONCLUSIONS This topical review offers practice recommendations to optimize and homogenize reporting in cross-sectional imaging in IBD.
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Affiliation(s)
- Torsten Kucharzik
- Department of Gastroenterology, Klinikum Lüneburg, University of Hamburg, Bögelstr. 1, 21339 Lüneburg, Germany
| | - Jeroen Tielbeek
- Department of Radiology, Spaarne Gasthuis, Boerhaavelaan 22, Haarlem, the Netherlands; Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Dan Carter
- Department of Gastroenterology, Chaim Sheba Medical Center, Tel Hasomher, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Stuart A Taylor
- Centre for Medical Imaging, University College London, London, UK
| | - Damian Tolan
- Radiology Department, St James's University Hospital, Leeds Teaching Hospitals NHS Trust, Beckett Street, Leeds, UK
| | - Rune Wilkens
- Gastrounit, Division of Medicine, Hvidovre University Hospital, Copenhagen, Denmark; Copenhagen Centre for Inflammatory Bowel Disease in Children, Adolescents and Adults, University of Copenhagen, Hvidovre Hospital, Copenhagen, Denmark
| | - Robert V Bryant
- Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, South Australia
| | - Christine Hoeffel
- Department of Abdominal Radiology, CHU Reims and CRESTIC, URCA, 51100 Reims, France
| | - Isabelle De Kock
- Department of Radiology, Ghent University Hospital, Ghent, Belgium
| | - Christian Maaser
- Outpatient Department of Gastroenterology, Department of Geriatrics, Klinikum Lüneburg, University of Hamburg, Bögelstr. 1, 21339 Lüneburg, Germany
| | - Giovanni Maconi
- Gastroenterology Unit, 'Luigi Sacco' University Hospital, Milan, Italy
| | - Kerri Novak
- Department of Radiology and Medicine, Division of Gastroenterology, University of Calgary, Alberta, Canada
| | - Søren R Rafaelsen
- Department of Radiology, University Hospital of Southern Denmark, Vejle, Denmark
| | - Martina Scharitzer
- Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.,IRCCS Humanitas Research Hospital, Division of Colon and Rectal Surgery, via Manzoni 56, 20089 Rozzano, Milan, Italy
| | - Jordi Rimola
- IBD unit, Radiology Department, Hospital Clínic Barcelona, Barcelona, Catalonia, Spain
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19
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Greer MLC, Taylor SA. Perianal Imaging in Crohn Disease: Current Status With a Focus on MRI, From the AJR Special Series on Imaging of Inflammation. AJR Am J Roentgenol 2022; 218:781-792. [PMID: 34549607 DOI: 10.2214/ajr.21.26615] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
Abstract
Fistulizing perianal disease, a frequent, chronic, and often debilitating manifestation of Crohn disease (CD) in adults and children, has been relatively refractory to treatment in the past. The advent of biologic agents such as anti-tumor necrosis factor-α and cellular therapies, used in conjunction with a range of surgical interventions, has greatly improved disease outcomes, although complete remission can still be elusive. This Special Series review considers current perianal imaging options, specifically pelvic MRI and endoanal and transperineal ultrasound, as well as their roles in the diagnosis, management, and assessment of treatment response. Pelvic MRI is the first-line modality for imaging perianal CD, given the complexity of fistulas encountered in CD. MRI technical acquisition parameters for adults and children and an approach to MRI interpretation and reporting are provided. Anatomic classification systems for fistulizing peri-anal disease are presented. We also explore the history, current landscape, and future developments of MRI features of perianal disease as imaging biomarkers, to quantify activity and severity and to consider CD MRI-based inflammatory activity scores. We discuss the reliability and validation of a number of indexes (including the pediatric MRI-based perianal CD [PEMPAC] index, the MR novel index for fistula imaging in CD [MAGNIFI-CD], the Van Assche index, and the modified Van Assche index), their potential to quantify treatment response, and possible prognostic capabilities.
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Affiliation(s)
- Mary-Louise C Greer
- Department of Diagnostic Imaging, The Hospital for Sick Children, 555 University Ave, Toronto, ON M5G 1X8, Canada
- Department of Medical Imaging, University of Toronto, Toronto, ON, Canada
| | - Stuart A Taylor
- Center for Medical Imaging, University College London, London, United Kingdom
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20
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Garg P, Yagnik VD, Dawka S, Kaur B, Menon GR. Guidelines to diagnose and treat peri-levator high-5 anal fistulas: Supralevator, suprasphincteric, extrasphincteric, high outersphincteric, and high intrarectal fistulas. World J Gastroenterol 2022; 28:1608-1624. [PMID: 35581966 PMCID: PMC9048780 DOI: 10.3748/wjg.v28.i16.1608] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2021] [Revised: 10/06/2021] [Accepted: 03/16/2022] [Indexed: 02/06/2023] Open
Abstract
Supralevator, suprasphincteric, extrasphincteric, and high intrarectal fistulas (high fistulas in muscle layers of the rectal wall) are well-known high anal fistulas which are considered the most complex and extremely challenging fistulas to manage. Magnetic resonance imaging has brought more clarity to the pathophysiology of these fistulas. Along with these fistulas, a new type of complex fistula in high outersphincteric space, a fistula at the roof of ischiorectal fossa inside the levator ani muscle (RIFIL), has been described. The diagnosis, management, and prognosis of RIFIL fistulas is reported to be even worse than supralevator and suprasphincteric fistulas. There is a lot of confusion regarding the anatomy, diagnosis, and management of these five types of fistulas. The main reason for this is the paucity of literature about these fistulas. The common feature of all these fistulas is their complete involvement of the external anal sphincter. Therefore, fistulotomy, the simplest and most commonly performed procedure, is practically ruled out in these fistulas and a sphincter-saving procedure needs to be performed. Recent advances have provided new insights into the anatomy, radiological modalities, diagnosis, and management of these five types of high fistulas. These have been discussed and guidelines formulated for the diagnosis and treatment of these fistulas for the first time in this paper.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Garg Fistula Research Institute,Panchkula 134113, Haryana, India
- Department of Colorectal Surgery, Indus International Hospital,Mohali 140201, Punjab, India
| | - Vipul D Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Center, Patan 384265, Gujarat, India
| | - Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive 744101,Mauritius
| | - Baljit Kaur
- Department of Radiology, SSRD Magnetic Resonance Imaging Institute, Chandigarh 160011, India
| | - Geetha R Menon
- Department of Statistics, Indian Council of Medical Research,New Delhi 110029, India
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21
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Garg P, Yagnik VD, Dawka S, Kaur B, Menon GR. A Novel MRI and Clinical-Based Scoring System to Assess Post-Surgery Healing and to Predict Long-Term Healing in Cryptoglandular Anal Fistulas. Clin Exp Gastroenterol 2022; 15:27-40. [PMID: 35210804 PMCID: PMC8860728 DOI: 10.2147/ceg.s343254] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2021] [Accepted: 02/07/2022] [Indexed: 12/12/2022] Open
Abstract
BACKGROUND Anal fistulas cause great uncertainty and anxiety in patients and surgeons alike. This is largely because of the inability to accurately confirm postoperative fistula healing, especially long-term healing. There is no scoring system available that can objectively assess cryptoglandular anal fistulas for postoperative healing and can also accurately predict long-term healing. METHODS Several parameters that could indicate anal fistula healing were assessed. Out of these, six parameters (four MRI-based and two clinical) were finalized, and a weighted score was given to each parameter. A novel scoring system (NSS) was developed. A minimum possible score (zero) indicated complete healing whereas the maximum weighted score (n = 20) indicated confirmed non-healing. Scoring was done with postoperative MRI (at least 3 months post-surgery), then compared with the actual healing status, and subsequently correlated with the final long-term clinical outcome. RESULTS The NSS was validated in 183 operated cryptoglandular fistula-in-ano patients over a 3-year period in whom 283 MRIs (preoperative plus postoperative) were performed. The postoperative follow-up was 12-48 months (median-30 months). The NSS was found to have a very high positive predictive value (98.2%) and moderately high negative predictive value (83.7%) for long-term fistula healing. Additionally, its sensitivity and specificity in predicting healing were 93.9% and 94.7%, respectively. CONCLUSION Thus, this new scoring system is highly accurate and would be a useful tool for surgeons and radiologists managing anal fistulas. By objectivizing the assessment of postoperative healing, it can both ease and streamline management. Moreover, reliable prediction of recurrence-free long-term healing will greatly allay the apprehensions associated with this dreaded disease.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Indus Super Specialty Hospital, Mohali, Punjab, India
- Department of Colorectal Surgery, Garg Fistula Research Institute Surgery, Panchkula, Haryana, India
| | - Vipul D Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Centre, Patan, Gujarat, India
| | - Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive, Mauritius
| | - Baljit Kaur
- Department of Radiology, SSRD MRI Imaging Centre, Chandigarh, Haryana, India
| | - Geetha R Menon
- National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India
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22
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Lansdorp CA, Buskens CJ, Gecse KB, Löwenberg M, Stoker J, Bemelman WA, D'Haens GRAM, van Hulst RA. Hyperbaric oxygen therapy for the treatment of perianal fistulas in 20 patients with Crohn's disease: Results of the HOT-TOPIC trial after 1-year follow-up. United European Gastroenterol J 2022; 10:160-168. [PMID: 35146959 PMCID: PMC8911540 DOI: 10.1002/ueg2.12189] [Citation(s) in RCA: 15] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/06/2021] [Accepted: 12/01/2021] [Indexed: 12/18/2022] Open
Abstract
Background Previously published short‐term results (week 16) of this trial showed a significant improvement in clinical, radiologic and biochemical outcomes in Crohn's disease patients with therapy‐refractory perianal fistulas after treatment with hyperbaric oxygen therapy. Objective To assess the long‐term (week 60) efficacy, safety and feasibility of hyperbaric oxygen therapy in perianal fistula in Crohn's disease. Methods Crohn's disease patients with high perianal fistula(s) failing conventional treatment >6 months were included. Exclusion criteria were presence of a stoma, rectovaginal fistula(s) and recent changes in treatment regimens. Patients received 40 hyperbaric oxygen sessions and outcomes were assessed at week 16 and week 60. Results Twenty patients were included (median age 34 years). At week 16, median scores of the perianal disease activity index and modified Van Assche index (co‐primary outcomes) decreased from 7.5 (95% CI 6–9) to 4 (95% CI 3–6, p < 0.001) and 9.2 (95% CI 7.3–11.2) to 7.3 (95% CI 6.9–9.7, p = 0.004), respectively. At week 60, the respective scores remained significantly lower than baseline: 4 (95% CI 3–7, p < 0.001) and 7.7 (95% CI 5.2–10.2, p = 0.003). Perianal disease activity index score of 4 or less (representing inactive perianal disease) was observed in 13 patients at week 16 and 12 patients at week 60. Using fistula drainage assessment, 12 and 13 patients showed a clinical response at week 16 and 60, respectively, and clinical remission was achieved in four patients for both time points. At week 16, a statistically significant biochemical improvement (C‐reactive protein and faecal calprotectin levels) was found, but this effect was no longer significant at week 60. Conclusions The clinical and radiologic improvement of perianal fistula in Crohn's disease, that was found at week 16 after treatment with hyperbaric oxygen therapy, is maintained at 1‐year follow‐up.
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Affiliation(s)
- Corine A Lansdorp
- Department of Anaesthesiology/Hyperbaric Medicine, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands
| | - Christianne J Buskens
- Department of Surgery, Amsterdam UMC, Location AMC, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
| | - Krisztina B Gecse
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands
| | - Mark Löwenberg
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
| | - Willem A Bemelman
- Department of Surgery, Amsterdam UMC, Location AMC, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands
| | - Geert R A M D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands
| | - Rob A van Hulst
- Department of Anaesthesiology/Hyperbaric Medicine, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands
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23
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van Rijn KL, Meima-van Praag EM, Bossuyt PM, D’Haens GR, Gecse KB, Horsthuis K, Snijder HJ, Tielbeek JAW, Buskens CJ, Stoker J. Fibrosis and MAGNIFI-CD Activity Index at Magnetic Resonance Imaging to Predict Treatment Outcome in Perianal Fistulizing Crohn's Disease Patients. J Crohns Colitis 2021; 16:708-716. [PMID: 34644395 PMCID: PMC9228904 DOI: 10.1093/ecco-jcc/jjab168] [Citation(s) in RCA: 19] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Characteristic magnetic resonance imaging [MRI] features associated with long-term perianal fistula closure are still being discussed. This study evaluated the predictive value of degree of fibrosis and disease activity (MAGNIFI-CD index) at MRI for long-term clinical closure of Crohn's perianal fistulas. METHODS Crohn's disease [CD] patients treated with surgical closure following anti-tumour necrosis factor [anti-TNF] induction or anti-TNF alone for high perianal fistulas as part of a patient preference randomized controlled trial [PISA-II] between 2013 and 2020 with a post-treatment MRI and long-term clinical follow-up data were retrospectively included. Two radiologists scored the degree of fibrosis and MAGNIFI-CD index at pre- and post-treatment MRI. The accuracy of post-treatment MRI findings in predicting long-term clinical closure [12 months after the MRI] was evaluated using receiver operating characteristics [ROC] analysis. RESULTS Fifty patients were included: 31 female, median age 33 years (interquartile range [IQR] 26-45). Fourteen patients showed a 100% fibrotic fistula at post-treatment MRI, all of which had long-term clinical closure. Median MAGNIFI-CD index at post-treatment MRI was 0 [IQR 0-5] in 25 patients with long-term clinical closure and 16 [IQR 10-20] in 25 patients without. ROC analysis showed an area under the curve of 0.90 (95% confidence interval [CI] 0.82-0.99) for degree of fibrosis and 0.95 [95% CI 0.89-1.00] for the MAGNIFI-CD index, with a Youden cut-off point of 6 [91% specificity, 87% sensitivity]. CONCLUSIONS Degree of fibrosis and MAGNIFI-CD index at post-treatment MRI are accurate in predicting long-term clinical closure and seem valuable in follow-up of perianal CD. A completely fibrotic tract at MRI is a robust indicator for long-term fistula closure. EUDRACT 2013-002932-25 and 2018-002064-15.
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Affiliation(s)
- Kyra L van Rijn
- Corresponding author: Kyra L. van Rijn, MD, Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands. Tel: +31 (0) 20 7320783;
| | - Elise M Meima-van Praag
- Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Patrick M Bossuyt
- Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands
| | - Geert R D’Haens
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Krisztina B Gecse
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Karin Horsthuis
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, Vrije Universiteit, De Boelelaan 1117, Amsterdam, The Netherlands
| | - Harmanna J Snijder
- Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Jeroen A W Tielbeek
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands,Department of Radiology, Spaarne Gasthuis, Haarlem, The Netherlands
| | - Christianne J Buskens
- Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
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Garg P, Kaur B, Yagnik VD, Dawka S, Menon GR. Guidelines on postoperative magnetic resonance imaging in patients operated for cryptoglandular anal fistula: Experience from 2404 scans. World J Gastroenterol 2021; 27:5460-5473. [PMID: 34588745 PMCID: PMC8433608 DOI: 10.3748/wjg.v27.i33.5460] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/08/2021] [Revised: 06/12/2021] [Accepted: 08/05/2021] [Indexed: 02/06/2023] Open
Abstract
Magnetic resonance imaging (MRI) is considered the gold standard for the evaluation of anal fistulas. There is sufficient literature available outlining the interpretation of fistula MRI before performing surgery. However, the interpretation of MRI becomes quite challenging in the postoperative period after the surgery of fistula has been undertaken. Incidentally, there are scarce data and no set guidelines regarding analysis of fistula MRI in the postoperative period. In this article, we discuss the challenges faced while interpreting the postoperative MRI, the timing of the postoperative MRI, the utility of MRI in the postoperative period for the management of anal fistulas, the importance of the active involvement and experience of the treating clinician in interpreting MRI scans, and the latest advancements in the field.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula 134113, Haryana, India
- Department of Colorectal Surgery, Indus International Hospital, Mohali 140201, Punjab, India
| | - Baljit Kaur
- Department of Radiology, SSRD Magnetic Resonance Imaging Institute, Chandigarh 160011, Chandigarh, India
| | - Vipul D Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Center, Patan 384265, Gujarat, India
| | - Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive, Mauritius
| | - Geetha R Menon
- Department of Statistics, Indian Council of Medical Research, New Delhi 110029, New Delhi, India
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25
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Gu B, De Gregorio M, Pipicella JL, Vande Casteele N, Andrews JM, Begun J, Connell W, D'Souza B, Gholamrezaei A, Hart A, Liew D, Radford-Smith G, Rimola J, Sutherland T, Toong C, Woods R, Wu Y, Xuan W, Williams AJ, Ng W, Ding NS, Connor S. Prospective randomised controlled trial of adults with perianal fistulising Crohn's disease and optimised therapeutic infliximab levels: PROACTIVE trial study protocol. BMJ Open 2021; 11:e043921. [PMID: 34210720 PMCID: PMC8252869 DOI: 10.1136/bmjopen-2020-043921] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
INTRODUCTION Perianal fistulising Crohn's disease (pfCD) can be somewhat treatment refractory. Higher infliximab trough levels (TLIs) may improve fistula healing rates; however, it remains unclear whether escalating infliximab therapy to meet higher TLI targets using proactive, or routine, therapeutic drug monitoring (TDM) improves outcomes. This randomised controlled trial aimed to assess whether infliximab therapy targeting higher TLIs guided by proactive TDM improves outcomes compared with standard therapy. METHODS AND ANALYSIS Patients with active pfCD will be randomised 1:1 to either the proactive TDM arm or standard dosing arm and followed up for 54 weeks. Patients in the proactive TDM arm will have infliximab dosing optimised to target higher TLIs. The targets will be TLI ≥ 25 µg/mL at week 2, ≥ 20 µg/mL at week 6 and ≥ 10 µg/mL during maintenance therapy. The primary objective will be fistula healing at week 32. Secondary objectives will include fistula healing, fistula closure, radiological fistula healing, patient-reported outcomes and economic costs up to 54 weeks. Patients in the standard dosing arm will receive conventional infliximab dosing not guided by TLIs (5 mg/kg at weeks 0, 2 and 6, and 5 mg/kg 8 weekly thereafter). Patients aged 18-80 years with pfCD with single or multiple externally draining complex perianal fistulas who are relatively naïve to infliximab treatment will be included. Patients with diverting ileostomies or colostomies and pregnant or breast feeding will be excluded. Fifty-eight patients per arm will be required to detect a 25% difference in the primary outcome measure, with 138 patients needed to account for an estimated 6.1% primary non-response rate and 10% dropout rate. ETHICS AND DISSEMINATION Results will be presented in peer-reviewed journals and international conferences. Ethics approval has been granted by the South Western Sydney Local Health District Human Research Ethics Committee in Australia. TRIAL REGISTRATION NUMBER Australian New Zealand Clinical Trials Registry (ACTRN12621000023853); Pre-results.
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Affiliation(s)
- Bonita Gu
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
| | - Michael De Gregorio
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
- Department of Gastroenterology and Hepatology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Joseph Louis Pipicella
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
- Biostatistics Unit, The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia
| | - Niels Vande Casteele
- Department of Medicine, University of California San Diego, La Jolla, California, USA
| | - Jane M Andrews
- Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
- Faculty of Health Sciences, The University of Adelaide, Adelaide, South Australia, Australia
| | - Jakob Begun
- Immunity, Infection, and Inflammation Program, Mater Research Institute, Brisbane, Queensland, Australia
- Department of Gastroenterology, Mater Hospital Brisbane, Brisbane, Queensland, Australia
| | - William Connell
- Department of Gastroenterology and Hepatology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Basil D'Souza
- Department of Colorectal Surgery, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Ali Gholamrezaei
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
- Biostatistics Unit, The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia
| | - Ailsa Hart
- Inflammatory Bowel Diseases Unit, St Mark's Hospital, Harrow, UK
| | - Danny Liew
- School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
| | - Graham Radford-Smith
- Department of Gastroenterology and Hepatology, Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
| | - Jordi Rimola
- Inflammatory Bowel Disease Unit, Department of Radiology, Hospital Clinic de Barcelona, Barcelona, Spain
| | - Tom Sutherland
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
- Medical Imaging Department, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Catherine Toong
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Immunology, NSW Health Pathology, Liverpool Hospital, Sydney, New South Wales, Australia
| | - Rodney Woods
- Department of Colorectal Surgery, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Yang Wu
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
| | - Wei Xuan
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Biostatistics Unit, The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia
| | - Astrid-Jane Williams
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
| | - Watson Ng
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
| | - Nik Sheng Ding
- Department of Medicine, The University of Melbourne, Melbourne, Victoria, Australia
- Department of Gastroenterology and Hepatology, St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
| | - Susan Connor
- South Western Sydney Clinical School, University of New South Wales, Sydney, New South Wales, Australia
- Department of Gastroenterology and Hepatology, Liverpool Hospital, Sydney, New South Wales, Australia
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Nuñez F P, Mahadevan U, Quera R, Bay C, Ibañez P. Treat-to-target approach in the management of inflammatory Bowel disease. GASTROENTEROLOGIA Y HEPATOLOGIA 2021; 44:312-319. [PMID: 33070988 DOI: 10.1016/j.gastrohep.2020.06.032] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 05/23/2020] [Accepted: 06/29/2020] [Indexed: 12/11/2022]
Abstract
With the advent of biologic and small molecule therapies, there has been a substantial change in the treatment of inflammatory bowel disease. These advances have had a great impact in preventing disease progression, intestinal damage and, therefore, have contributed to a better quality of life. Discordance between symptom control and mucosal healing has been demonstrated. This has led to the search for new disease control targets. The treat to target strategy, based on expert recommendations and now a randomized controlled trial, has determined that clinical and endoscopic remission should be the goal of therapy. Biomarkers (fecal calprotectin) can be a surrogate target. Although histological healing has shown benefits, there is inadequate evidence and inadequate therapy for that to be a fixed goal at this time. This review will focus on therapeutic goals, according to the evidence currently available, and evaluate strategies to achieve them.
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Affiliation(s)
- Paulina Nuñez F
- Division of Gastroenterology, Unversity of Chile, Hospital San Juan de Dios, Santiago, Chile a Division of Gastroenterology, Unversity of Chile, Hospital San Juan de Dios, Santiago, Chile.
| | - Uma Mahadevan
- Division of Gastroenterology, University of California, San Francisco, United States
| | - Rodrigo Quera
- Inflammatory Bowel Disease Program, Gastroenterology Department, Clínica Las Condes, Santiago, Chile
| | - Constanza Bay
- Department of Pediatrics, Pontifical Catholic University of Chile, Santiago, Chile
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27
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Meima ‐ van Praag EM, van Rijn KL, Monraats MA, Buskens CJ, Stoker J. Magnetic resonance imaging after ligation of the intersphincteric fistula tract for high perianal fistulas in Crohn's disease: a retrospective cohort study. Colorectal Dis 2021; 23:169-177. [PMID: 32767809 PMCID: PMC7891352 DOI: 10.1111/codi.15296] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2020] [Accepted: 07/28/2020] [Indexed: 12/16/2022]
Abstract
AIM Ligation of the intersphincteric fistula tract (LIFT) is increasingly being used for surgical closure of high perianal fistulas in Crohn's disease. Currently, data on postoperative MRI findings are scarce, although they are considered important for assessing healing and recurrence. Our aim, therefore, was to evaluate fistula characteristics on MRI and their relationship with clinical outcomes after LIFT. METHOD Consecutive Crohn's patients treated with LIFT between 2007 and 2018 who underwent baseline and follow-up MRI were retrospectively included. MRIs were scored by two radiologists according to characteristics based on the original and modified Van Assche indices. MRI findings, with emphasis on fibrosis, and the relationship with clinical healing, re-interventions and recurrences are described. RESULTS Twelve patients were included [four men, median age 34 (interquartile range 28-39) years]. Follow-up MRI was performed at a median of 5.5 months (interquartile range 2.5-6.0) after LIFT. At baseline, all patients showed a tract with predominantly granulation tissue, which changed to predominantly fibrotic in seven (in three of whom it was completely fibrotic). All patients with a (predominantly) fibrotic tract had clinical closure and no re-interventions or recurrences during long-term follow-up. In contrast, of the five patients with persisting granulation tissue, two reached clinical healing, two needed re-intervention and one had a recurrence. CONCLUSION Markedly decreased fistula activity can be observed on MRI after LIFT. The majority of patients develop a predominantly fibrotic tract relatively soon after LIFT without clinical recurrence, suggesting a highly effective therapy. Unfavourable clinical outcomes were only present in patients with persisting granulation tissue, indicating the potential prognostic value of MRI.
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Affiliation(s)
- E. M. Meima ‐ van Praag
- Department of SurgeryAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - K. L. van Rijn
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - M. A. Monraats
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - C. J. Buskens
- Department of SurgeryAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - J. Stoker
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
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28
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Miranda EF, Nones RB, Kotze PG. Correlation of serum levels of anti-tumor necrosis factor agents with perianal fistula healing in Crohn's disease: a narrative review. Intest Res 2020; 19:255-264. [PMID: 33147899 PMCID: PMC8322024 DOI: 10.5217/ir.2020.00029] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/16/2020] [Accepted: 06/26/2020] [Indexed: 02/07/2023] Open
Abstract
With the overspread use of measurement of serum levels of anti-tumor necrosis factor (TNF) agents (therapeutic drug monitoring, TDM), new therapeutic strategies have been used in the management of Crohn’s disease (CD). Different targets are correlated with increased levels of circulating drugs. Recent evidence demonstrated that higher serum levels of anti-TNF agents may be associated to better outcomes in perianal fistulizing CD (PFCD). Overall, patients with healed fistulas had higher serum levels of infliximab and adalimumab as compared to those with active drainage. This was demonstrated in some cohort studies, in induction and maintenance, in adults and children with PFCD. In this narrative review, authors summarize current evidence on the use of serum level measurement of anti-TNF agents and its correlation with perianal fistula healing in CD patients. Data on the use of TDM in PFCD is discussed in detail. The retrospective design of the studies and the lack of objective parameters to measure fistula healing are the main limitations of published data. Prospective studies, with central reading of objective radiological parameters, such as pelvic magnetic resonance imaging scores, can improve the level of evidence on the possible advantages of TDM in perianal fistula in CD and are warranted.
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Affiliation(s)
- Eron Fabio Miranda
- Colorectal Surgery Unit, IBD Outpatient Clinics, Catholic University of Paraná (PUCPR), Curitiba, Brazil
| | | | - Paulo Gustavo Kotze
- Colorectal Surgery Unit, IBD Outpatient Clinics, Catholic University of Paraná (PUCPR), Curitiba, Brazil
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