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Doi S, Namura Y, Kikuyama T, Saito G, Adachi T, Matsumoto K, Watanabe A, Tsunashima H, Katsukura N, Tsujikawa T, Yasuda I. Novel anti-reflux biliary metal stent with a distal tapered end for distal malignant biliary obstruction: a feasibility study. Endosc Int Open 2023; 11:E460-E465. [PMID: 37180308 PMCID: PMC10169231 DOI: 10.1055/a-2039-3853] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/07/2022] [Accepted: 02/15/2023] [Indexed: 05/16/2023] Open
Abstract
Background and study aims We developed a self-expandable metallic stent (SEMS) with a distal tapered end to reproduce the physiological bile flow with a pressure gradient due to the difference in the diameter. We aimed to evaluate the safety and efficacy of the newly developed distal tapered covered metal stent (TMS) for distal malignant biliary obstruction (DMBO). Patients and methods This single-center, prospective, single-arm study was conducted in patients with DMBO. The primary endpoint was time to recurrent biliary obstruction (TRBO), and the secondary endpoints were the survival time and incidence of adverse events (AEs). Results Thirty-five patients (15 men, 20 women; median age, 81 years [range: 53-92]) were enrolled between December 2017 and December 2019. The primary diseases were pancreatic head cancer in 25 cases, bile duct cancer in eight cases, and ampullary cancer in two cases. TMS was successfully placed in all cases. Acute cholecystitis occurred as an early AE (within 30 days) in two cases (5.7 %). The median TRBO was 503 days, median survival time was 239 days. RBO was observed in 10 cases (28.6 %), and the causes were distal migration in six cases, proximal migration in two cases, biliary sludge in one case, and tumor overgrowth in one case. Conclusions Endoscopic placement of the newly developed TMS in patients with DMBO is technically feasible and safe, and the TRBO was remarkably long. The anti-reflux mechanism based on the difference in diameter may be effective, and a randomized controlled trial with a conventional SEMS is required.
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Affiliation(s)
- Shinpei Doi
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Yuta Namura
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Tomohiro Kikuyama
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Go Saito
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Takako Adachi
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Kotaro Matsumoto
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Ayako Watanabe
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Hiromichi Tsunashima
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Nobuhiro Katsukura
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Takayuki Tsujikawa
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa Japan
| | - Ichiro Yasuda
- Third Department of Internal Medicine, University of Toyama, Toyama, Japan
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Susak YM, Markulan LL, Lobanov SM, Palitsya RY, Rudyk MP, Skivka LM. Effectiveness of a new approach to minimally invasive surgery in palliative treatment of patients with distal malignant biliary obstruction. World J Gastrointest Surg 2023; 15:698-711. [PMID: 37206076 PMCID: PMC10190736 DOI: 10.4240/wjgs.v15.i4.698] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/17/2022] [Revised: 02/05/2023] [Accepted: 03/06/2023] [Indexed: 04/22/2023] Open
Abstract
BACKGROUND Palliative endoscopic biliary drainage is the primary treatment option for the management of patients with jaundice which results from distal malignant biliary obstruction (DMBO). In this group of patients, decompression of the bile duct (BD) allows for pain reduction, symptom relief, chemotherapy administration, improved quality of life, and increased survival rate. To reduce the unfavorable effects of BD decompression, minimally invasive surgical techniques require continuous improvement.
AIM To develop a technique for internal-external biliary-jejunal drainage (IEBJD) and assess its effectiveness in comparison to other minimally invasive procedures in the palliative treatment of patients with DMBO.
METHODS A retrospective analysis of prospectively collected data was performed, which included 134 patients with DMBO who underwent palliative BD decompression. Biliary-jejunal drainage was developed to divert bile from the BD directly into the initial loops of the small intestine to prevent duodeno-biliary reflux. IEBJD was carried out using percutaneous transhepatic access. Percutaneous transhepatic biliary drainage (PTBD), endoscopic retrograde biliary stenting (ERBS), and internal-external transpapillary biliary drainage (IETBD) were used for the treatment of study patients. Endpoints of the study were the clinical success of the procedure, the frequency and nature of complications, and the cumulative survival rate.
RESULTS There were no significant differences in the frequency of minor complications between the study groups. Significant complications occurred in 5 (17.2%) patients in the IEBJD group, in 16 (64.0%) in the ERBS group, in 9 (47.4%) in the IETBD group, and in 12 (17.4%) in the PTBD group. Cholangitis was the most common severe complication. In the IEBJD group, the course of cholangitis was characterized by a delayed onset and shorter duration as compared to other study groups. The cumulative survival rate of patients who underwent IEBJD was 2.6 times higher in comparison to those of the PTBD and IETBD groups and 20% higher in comparison to that of the ERBS group.
CONCLUSION IEBJD has advantages over other minimally invasive BD decompression techniques and can be recommended for the palliative treatment of patients with DMBO.
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Affiliation(s)
- Yaroslav M Susak
- Department of Surgery with the Course of Emergency and Vascular Surgery, O.O. Bogomolets National Medical University, Kyiv 01601, Ukraine
| | - Leonid L Markulan
- Department of Surgery with the Course of Emergency and Vascular Surgery, O.O. Bogomolets National Medical University, Kyiv 01601, Ukraine
| | - Serhii M Lobanov
- Department of Surgery with the Course of Emergency and Vascular Surgery, O.O. Bogomolets National Medical University, Kyiv 01601, Ukraine
| | - Roman Y Palitsya
- Department of Abdominal Surgery, National Military Medical Clinical Centre “Main Military Clinical Hospital”, Kyiv 01133, Ukraine
| | - Mariia P Rudyk
- Department of Microbiology and Immunology, Taras Shevchenko National University of Kyiv, Kyiv 01033, Ukraine
| | - Larysa M Skivka
- Department of Microbiology and Immunology, Taras Shevchenko National University of Kyiv, Kyiv 01033, Ukraine
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Takeda T, Sasaki T, Yamada Y, Okamoto T, Mie T, Furukawa T, Kasuga A, Matsuyama M, Ozaka M, Sasahira N. The efficacy and safety of a duckbill-type anti-reflux metal stent as the initial metal stent for distal malignant biliary obstruction in unresectable pancreatic cancer. DEN OPEN 2023; 3:e205. [PMID: 36636718 PMCID: PMC9829095 DOI: 10.1002/deo2.205] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 11/18/2022] [Revised: 12/03/2022] [Accepted: 12/17/2022] [Indexed: 01/11/2023]
Abstract
Background The usefulness of duckbill-type anti-reflux metal stent (DMS) in self-expandable metal stent-naïve pancreatic cancer (PC) patients has not been well-studied. This study aimed to evaluate the efficacy and safety of DMS in such patients. Methods We analyzed consecutive patients with unresectable PC who received a covered metal stent (CMS) as the initial self-expandable metal stent at our institution. Technical success, functional success, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates were compared between DMS and conventional CMS (c-CMS). Results A total of 69 patients were included (DMS: 28, c-CMS: 41). Technical success, functional success, and AEs were similar between groups. Tumor ingrowth was more common in the DMS group (18% vs. 0%, p = 0.009), while non-occlusion cholangitis tended to be more common in the c-CMS group (0% vs. 15%, p = 0.074). Median time to RBO was similar between groups (276 vs. 273 days, p = 0.915). The anti-reflux valve of DMS was found torn in 56% of patients. Endoscopic reintervention was successful in all cases, despite failed stent removal in 88% of patients in the DMS group. Conclusions DMS was not associated with longer time to RBO compared to c-CMS in self-expandable metal stent-naïve patients.
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Affiliation(s)
- Tsuyoshi Takeda
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takashi Sasaki
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Yuto Yamada
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan,Department of Internal medicineDivision of Gastroenterology and HepatologyToho UniversityTokyoJapan
| | - Takeshi Okamoto
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takafumi Mie
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Takaaki Furukawa
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Akiyoshi Kasuga
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Matsuyama
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Masato Ozaka
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
| | - Naoki Sasahira
- Department of Hepato‐Biliary‐Pancreatic MedicineCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
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Long-term outcomes of duckbill-type anti-reflux metal stents versus conventional covered metal stents in reinterventions after covered biliary metal stent dysfunction in unresectable pancreatic cancer. Surg Endosc 2022; 37:3498-3506. [PMID: 36581786 DOI: 10.1007/s00464-022-09836-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/31/2022] [Accepted: 12/16/2022] [Indexed: 12/31/2022]
Abstract
BACKGROUND The use of duckbill-type anti-reflux metal stents (DMS) in reinterventions after covered metal stent (CMS) dysfunction has been reported in patients with distal malignant biliary obstruction (MBO). However, the superiority of DMS over conventional CMS (c-CMS) has not been established. Therefore, we conducted this retrospective study to evaluate the long-term efficacy and safety of DMS as a second stent in comparison with c-CMS. METHODS We investigated consecutive patients with distal MBO due to unresectable pancreatic cancer who underwent reintervention after dysfunction of initial biliary CMS at our institution. We compared causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), adverse events (AEs), and reintervention rates of DMS and c-CMS in this stenting. RESULTS A total of 76 patients were included (DMS 41 and c-CMS 35). While overall RBO rates were similar between the two groups (46% vs. 63%, p = 0.172), RBO due to non-occlusion cholangitis tended to be less frequent in the DMS group than in the c-CMS group (2% vs. 14%, p = 0.089). Median TRBO was significantly longer in the DMS group (286 days vs. 112 days, p = 0.029). DMS was identified as the only significant risk factor for TRBO (hazard ratio, 0.52; p = 0.044). Overall AE rates were significantly lower in the DMS group (2% vs. 23%, p = 0.010), with non-occlusion cholangitis being the most common AE in the c-CMS group. Endoscopic reintervention was successfully performed in all patients in both groups, despite failed stent removal in 15% of patients in DMS group. CONCLUSIONS DMS was associated with a significantly longer TRBO and lower rate of AEs compared with c-CMS in reinterventions after initial CMS dysfunction. DMS may be preferable to c-CMS as a second stent after biliary CMS dysfunction.
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Kobori I, Katayama Y, Hayakawa F, Fujiwara T, Kuwada M, Gyotoku Y, Kitahama A, Kusano Y, Tamano M. Usefulness of duckbill‐type anti‐reflux self‐expandable metal stents for distal malignant biliary obstruction with duodenal invasion: A pilot study. DEN OPEN 2022; 2:e103. [PMID: 35873508 PMCID: PMC9302046 DOI: 10.1002/deo2.103] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/26/2021] [Revised: 01/24/2022] [Accepted: 02/05/2022] [Indexed: 12/05/2022]
Abstract
Objectives Early obstruction of a self‐expandable metal stent placed for distal malignant biliary obstruction is more likely to occur in the presence of duodenal invasion. An anti‐reflux self‐expandable metal stent (ARMS) has been developed for the purpose of preventing duodenal fluid reflux into the bile duct. In this study, we evaluated the usefulness and safety of a duckbill‐type ARMS (D‐ARMS) in the situation of duodenal invasion. Methods We retrospectively analyzed 10 consecutive patients who received D‐ARMS for distal malignant biliary obstruction with duodenal invasion. We evaluated non‐occlusion cholangitis, recurrent biliary obstruction (RBO), and adverse events after D‐ARMS placement. Results There were no cases of non‐occlusion cholangitis. RBO was observed in 2 patients (20%), and time to RBO was 236 days and 117 days, respectively. The causes of RBO were overgrowth and sludge formation. The median time to RBO was 382 days (range, 117–382 days). Only one adverse event was observed (cholecystitis). Conclusions D‐ARMS shows potential as an optimal ARMS.
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Affiliation(s)
- Ikuhiro Kobori
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Yasumi Katayama
- Endoscopy Center, Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Fuki Hayakawa
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Takeshi Fujiwara
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Masaru Kuwada
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Yoshinori Gyotoku
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Akihiro Kitahama
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Yumi Kusano
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
| | - Masaya Tamano
- Department of Gastroenterology Dokkyo Medical University Saitama Medical Center Saitama Japan
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Su Y, Xiang Z, Song X, Zheng S, Xu X. Design and Optimization of a New Anti-reflux Biliary Stent With Retractable Bionic Valve Based on Fluid-Structure Interaction Analysis. Front Bioeng Biotechnol 2022; 10:824207. [PMID: 35419358 PMCID: PMC8995556 DOI: 10.3389/fbioe.2022.824207] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/29/2021] [Accepted: 03/14/2022] [Indexed: 11/13/2022] Open
Abstract
Duodenal biliary reflux has been a challenging common problem which could cause dreadful complications after biliary stent implantation. A novel anti-reflux biliary stent with a retractable bionic valve was proposed according to the concertina motion characteristics of annelids. A 2D equivalent fluid-structure interaction (FSI) model based on the axial section was established to analyze and evaluate the mechanical performances of the anti-reflux biliary stent. Based on this model, four key parameters (initial shear modulus of material, thickness, pitch, and width) were selected to investigate the influence of design parameters on anti-reflux performance via an orthogonal design to optimize the stent. The results of FSI analysis showed that the retrograde closure ratio of the retractable valve primarily depended on initial shear modulus of material (p < 0.05) but not mainly depended on the thickness, pitch, and width of the valve (p > 0.05). The optimal structure of the valve was finally proposed with a high retrograde closing ratio of 95.89%. The finite element model revealed that the optimized anti-reflux stent possessed improved radial mechanical performance and nearly equal flexibility compared with the ordinary stent without a valve. Both the FSI model and experimental measurement indicated that the newly designed stent had superior anti-reflux performance, effectively preventing the duodenobiliary reflux while enabling the bile to pass smoothly. In addition, the developed 2D equivalent FSI model provides tremendous significance for resolving the fluid-structure coupled problem of evolution solid with large deformation and markedly shortens the calculation time.
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Affiliation(s)
- Yushan Su
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Zhongxia Xiang
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Xiaofei Song
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Shuxian Zheng
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
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Сусак Я, Маркулан Л, Палица Р. External-Internal Biliary-Jejunal Drainage in Palliative Treatment of Distal Mechanical Jaundice. ХИРУРГИЯ. ВОСТОЧНАЯ ЕВРОПА 2021:205-219. [DOI: 10.34883/pi.2021.10.2.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/02/2025]
Abstract
Введение. Метод выбора дренирования желчных протоков у пациентов с дистальной злокачественной механической желтухой (ДЗМЖ) остается дискуссионным.Цель. Разработать и внедрить в клиническую практику методику наружно-внутреннего билиарно-еюнального дренирования и сравнить ее результаты с ретроградным эндоскопическим стентированием при паллиативном лечении дистальной механической желтухи.Материалы и методы. В проспективное исследование вошло 54 пациента с ДЗМЖ: 29 пациентам выполнена разработанная методика наружно-внутреннего билиарно-еюнального дренирования (группа НВБЕД); 25 – эндоскопическое ретроградное билиарное стентирование (группа ЭРБС) с использованием непокрытых металлических стентов. НВБЕД проводилась с использованием предложенного дренажа, устанавливаемого посредством чрескожного чреспеченочного доступа, при этом конец дренажа с дистальной группой боковых отверстий размещался в начальных петлях еюнум, проксимальная группа боковых отверстий – в расширенных желчных протоках над стенозом.Точками исследования были клинический успех процедуры, частота и характер осложнений, накопленная выживаемость, накопленное время проходимости стента.Результаты. Клинический успех процедуры достигнут в группе НВБЕД у 82,1% пациентов, в группе ЭРБС – у 84,0% (р>0,05).В группе НВБЕД осложнения возникли у 5 (17,9%) пациентов, в группе ЭРБС – у 16 (64,0%) (р=0,002), в том числе холангит – у 10,3% против 36,0% (р=0,024) и панкреатит у 6,9%, против 36,0% (р=0,023) соответственно.При использовании НВБЕД накопленное выживание составило 252,3 дня (95% ДИ: 207,5–297,1) против 203,3 дня (95% ДИ: 164,5–242,1) в группе ЭРБС (р=0,072). Это мы связываем со снижением частоты холангита в группе НВБЕД. В целом накопленное выживание составило 248,9 дня (95% ДИ: 212,2–285,5) при отсутствии у пациентов эпизодов холангита против 168,8 дня (95% ДИ: 132,3–205,4) при наличии холангита (р=0,005).У пациентов с холангитом накопленное время проходимости стентов составляло 157,1 дня (95% ДИ: 132,1–182,1), при отсутствии холангита – 269,6 дня (95% ДИ: 230,3–309,0), р=0,005. У пациентов с НВБЕД закупорки просвета дренажа не наблюдали.Заключение. Предложенная методика наружно-внутреннего билиарно-еюнального дренирования при паллиативном лечении дистальной механической желтухи предпочтительнее эндоскопического ретроградного билиарного стентирования.
Introduction. The choice of bile duct drainage in patients with distal malignant obstructive jaundice (DMOJ) remains controversial.Purpose. To develop and introduce into clinical practice a technique for external-internal biliary- jejunal drainage and compare its results with retrograde endoscopic stenting in palliative treatment of DMOJ.Materials and methods. The prospective study included 54 patients with DMOJ: 29 patients underwent the developed method of external-internal biliary-jejunal drainage (NVBED group); 25 – endoscopic retrograde biliary stenting (ERPS group) using metal stents. NVBED was carried out using the proposed drainage installed by means of a percutaneous transhepatic approach, while the end of the drainage with the distal group of lateral holes was located in the initial loops of the jejunum, the proximal group of lateral holes – in the dilated bile ducts above the stenosis.The points of the study were the clinical success of the procedure, frequency and nature of complications, accumulated survival rate, accumulated time of stent patency.Results. Clinical success of the procedure was achieved in 82.1% of patients in the NVBED group, and 84.0% of patients in the ERHD group, p>0.05.In the IVBED group, complications occurred in 5 (17.9%) patients, in the ERHD group – in 16 (64.0%) patients, p=0.002, including cholangitis – in 10.3% versus 36.0% (p=0.024) and pancreatitis – in 6.9% versus 36.0% (p=0.023), respectively.When using NVBED, the cumulative survival was 252.3 days (95% CI: 207.5–297.1) versus 203.3 days (95% CI: 164.5–242.1) in the ERBS group (p=0.072). We associate this with the decrease of the incidence of cholangitis in the IVBED group. Thus, the overall cumulative survival was 248.9 days (95% CI: 212.2–285.5) in the absence of cholangitis episodes versus 168.8 days (95% CI: 132.3–205.4) in the presence of cholangitis, p=0.005.In patients with cholangitis, the cumulative time of stent patency was 157.1 days (95% CI: 132.1– 182.1); in the absence of cholangitis – 269.6 days (95% CI: 230.3–309.0, p=0.005. In patients with NVBED, the drainage lumen blockage was not observed.Conclusion. The proposed method of external-internal biliary-jejunal drainage for palliative treatment of distal obstructive jaundice is preferable in comparison with endoscopic retrograde biliary stenting.
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Kin T, Ishii K, Okabe Y, Itoi T, Katanuma A. Feasibility of biliary stenting to distal malignant biliary obstruction using a novel designed metal stent with duckbill-shaped anti-reflux valve. Dig Endosc 2021; 33:648-655. [PMID: 32875614 DOI: 10.1111/den.13827] [Citation(s) in RCA: 21] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/21/2020] [Revised: 08/06/2020] [Accepted: 08/19/2020] [Indexed: 02/06/2023]
Abstract
OBJECTIVES Anti-reflux metal stent (ARMS) has been used to prevent recurrent biliary obstruction (RBO) due to sludge formation or food impaction. However, the most suitable ARMS remains to be identified. This study aimed to evaluate the feasibility, safety, and efficacy of biliary drainage using duckbill-shaped ARMS (D-ARMS). METHODS This was a multicenter, retrospective observational study conducted at three Japanese tertiary institutions. Patients with distal malignant biliary obstruction who underwent biliary stenting using D-ARMS were eligible to participate. Technical success, functional success, adverse event (AE), and time to RBO (TRBO) were evaluated. RESULTS Thirty patients underwent biliary stenting using D-ARMS from December 2018 to October 2019. The technical success rate and functional success rate were 93% and 87%, respectively. However, nonvisibility of the markers at the tip of the metal stent or spontaneous extension was occasionally observed, making biliary stenting using D-ARMS difficult. Early AE occurred in 10% of the patients including cholangitis and pancreatitis. During the median postprocedural observation time of 5.1 months (range, 0.8-22.8), RBO occurred in 33% and the median TRBO was 261 days. As for reintervention, D-ARMS could be extracted in 67% of the patients with RBO. However, the stent was torn off on removal in half of the patients. CONCLUSIONS Although some modifications are still needed, D-ARMS was feasible and safe for biliary drainage, and sufficient TRBO was achieved. Subsequent multi-institutional studies involving a larger number of patients and a longer follow-up period are warranted to validate the present results.
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Affiliation(s)
- Toshifumi Kin
- Center for Gastroenterology, Teine-Keijinkai Hospital, Hokkaido, Japan
| | - Kentaro Ishii
- Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan
| | - Yoshinobu Okabe
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Fukuoka, Japan
| | - Takao Itoi
- Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan
| | - Akio Katanuma
- Center for Gastroenterology, Teine-Keijinkai Hospital, Hokkaido, Japan
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Yamada Y, Sasaki T, Takeda T, Mie T, Furukawa T, Kasuga A, Matsuyama M, Ozaka M, Igarashi Y, Sasahira N. A novel laser-cut fully covered metal stent with anti-reflux valve in patients with malignant distal biliary obstruction refractory to conventional covered metal stent. JOURNAL OF HEPATO-BILIARY-PANCREATIC SCIENCES 2021; 28:563-571. [PMID: 33835728 DOI: 10.1002/jhbp.966] [Citation(s) in RCA: 17] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/31/2021] [Revised: 03/08/2021] [Accepted: 04/04/2021] [Indexed: 12/14/2022]
Abstract
BACKGROUND Stenting against recurrent biliary obstruction (RBO) after placement of covered metal stent (CMS) for distal malignant biliary obstruction (MBO) is still challenging. This study investigated the feasibility of a novel laser-cut fully CMS with anti-reflux valve in patients with distal MBO refractory to conventional CMS. METHODS Patients who underwent Duckbill-type metal stent (DMS) placement between June 2019 and May 2020 were included. Early complications, causes of RBO including non-occlusion cholangitis, and time to RBO (TRBO) were evaluated. TRBO of DMS was also compared with that of previous CMS. RESULTS Thirty patients were included: pancreatic cancer/metastatic lymph nodes in 29 patients/one patient; duodenal stenosis in 13 patients. Technical and functional success were achieved in all patients. Mild cholangitis and mild pancreatitis developed in each one. Median follow-up period was 167 days (range, 23-527 days). RBO occurred in nine patients (30%): sludge formation in four patients, hemobilia in one patient, symptomatic distal stent migration in three patients, and non-occlusion cholangitis in one patient. TRBO of DMS was significantly longer than that of previous CMS (median 224 days vs median 120 days, P = .0025). DMS was successfully removed in all of six patients when re-intervention was needed. CONCLUSIONS Duckbill-type metal stent might be safe and effective in patients with distal MBO refractory to conventional CMS.
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Affiliation(s)
- Yuto Yamada
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.,Division of Gastroenterology and Hepatology, Department of Internal Medicine, Omori Medical Center, Toho University, Tokyo, Japan
| | - Takashi Sasaki
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Tsuyoshi Takeda
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Takafumi Mie
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Takaaki Furukawa
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Akiyoshi Kasuga
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Masato Matsuyama
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Masato Ozaka
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
| | - Yoshinori Igarashi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Omori Medical Center, Toho University, Tokyo, Japan
| | - Naoki Sasahira
- Department of Hepato-Biliary-Pancreatic Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan
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10
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Hamada T, Nakai Y, Isayama H, Koike K. Antireflux metal stent for biliary obstruction: Any benefits? Dig Endosc 2021; 33:310-320. [PMID: 32250476 DOI: 10.1111/den.13679] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/01/2020] [Revised: 03/10/2020] [Accepted: 03/26/2020] [Indexed: 12/12/2022]
Abstract
Endoscopic retrograde cholangiopancreatography with stent placement has been utilized as standard palliative management of distal malignant biliary obstruction (MBO). Compared to plastic stents, metal stents can provide longer-term relief of symptoms. When a large-bore metal stent is placed across the ampulla, patients are predisposed to the risk of cholangitis or stent dysfunction due to reflux of duodenal contents. To mitigate the risk of adverse events associated with the duodenobiliary reflux, efforts have been directed to development of antireflux metal stents (ARMSs). The antireflux property has been introduced through adding of an antireflux valve to the duodenal stent end. Evidence from clinical studies indicates that ARMSs may not only reduce the risk of ascending cholangitis during follow-up but also prolong stent patency time. However, the results of clinical studies testing ARMSs are inconsistent owing to heterogeneous designs of antireflux valves and stent bodies. Metal stents are increasingly indicated for benign biliary strictures and MBO in the setting of neoadjuvant chemotherapy, and therefore, research is warranted to evaluate ARMSs for those indications. Given that endoscopic ultrasound (EUS)-guided transmural biliary drainage has gained popularity, the optimal timing of placing an ARMS in relation to EUS-guided and percutaneous drainage should be investigated. Development and evaluation of ARMSs require an integrative approach utilizing phantom and animal models, measurements of stent mechanical properties, and in vivo functional study after stent placement. In this review article, we summarize updated evidence on ARMSs for MBO and discuss issues that should be addressed in future studies.
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Affiliation(s)
- Tsuyoshi Hamada
- Departments of, Department of, Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Yousuke Nakai
- Departments of, Department of, Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.,Department of, Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, Juntendo University, Tokyo, Japan
| | - Kazuhiko Koike
- Departments of, Department of, Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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11
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Wang Y, Song XF, Su YS, Xu XS. Design and evaluation of a novel anti-reflux biliary stent with cone spiral valve. Proc Inst Mech Eng H 2020; 235:54-64. [PMID: 32988290 DOI: 10.1177/0954411920959986] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Endoscopic placement of biliary stent is a well-established palliative treatment for biliary obstruction. However, duodenobiliary reflux after stent placement has been a common problem which may lead to dreadful complications. This paper designed a novel anti-reflux biliary stent with a cone spiral valve. Fluid-Structure Interaction (FSI) simulations were established to evaluate the efficiency of the anti-reflux stent comparing with a clinically applied standard stent. According to the stress distribution of the valve, the fatigue performance in the stress concentration area was analyzed. The results show that when the antegrade flow through the valve, the cone spiral valve could stretch and open to realize adequate drainage under the normal physiological pressure of biliary tract; When the duodenal reflux through the valve, the valve would be compressed and close with a result of nearly zero at the outlet flow rate. Furthermore, the anti-reflux stent achieved improved radial mechanical performance with 2.7 times higher radial stiffness than standard stent. Finite element analysis (FEA) also indicates that compared with the standard stent, the addition of the anti-reflux valve had little negative effect on flexibility of the stent. Fatigue analysis results showed that the valve was reliable. This research provides the new stent with a cone spiral valve and proves that it is technically feasible and effective for preventing the duodenobiliary reflux while ensuring the antegrade bile flow without compromising the other biomechanical performances.
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Affiliation(s)
- Yue Wang
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Xiao-Fei Song
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Yu-Shan Su
- Key Laboratory of Mechanism Theory and Equipment Design of Ministry of Education, Tianjin University, Tianjin, China
| | - Xin-Sheng Xu
- Nankai Hospital, Nankai University, Tianjin, China
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12
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Shabunin AV, Tavobilov MM, Lebedev SS, Karpov AA. [Mechanisms and prevention of biliary stent occlusion]. Khirurgiia (Mosk) 2020:70-75. [PMID: 32500692 DOI: 10.17116/hirurgia202005170] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
One of significant achievements of modern endoscopy is development of retrograde biliary stenting for obstructive jaundice. This method ensured widespread application of endoscopic decompression in the treatment of patients with malignant biliary obstruction as preparation before radical surgery and final palliative care. Endoscopic retrograde transpapillary stenting firmly took its place together with antegrade and percutaneous stenting. There are certain advantages of this technique including minimally invasiveness and favorable quality of life. However, this approach is associated with some drawbacks associated with stent occlusion and difficult correction of this complication. The maximum diameter of the plastic stent (PS) is determined by the width of the working channel of the duodenoscope. In this regard, self-expandable metal stents (SEMS) were developed to increase the diameter of bile drainage channel. SEMS are associated with prolonged function. However, there is another problem. It is a germination of SEMS followed by impossible removal of the stent for its subsequent replacement. A further step in development of endoscopic biliary stents was the use of special SEMS coating to exclude tumor or granulation ingrowth. The problem of biliary stent occlusion remains relevant despite some improvement of stenting results. Mechanisms of occlusion of biliary stents and prevention of these events are discussed in this review.
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Affiliation(s)
- A V Shabunin
- Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.,Botkin Municipal Clinical Hospital of the Moscow Healthcare Department, Moscow, Russia
| | - M M Tavobilov
- Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.,Botkin Municipal Clinical Hospital of the Moscow Healthcare Department, Moscow, Russia
| | - S S Lebedev
- Russian Medical Academy for Continuing Professional Education of the Ministry of Health of Russia, Moscow, Russia.,Botkin Municipal Clinical Hospital of the Moscow Healthcare Department, Moscow, Russia
| | - A A Karpov
- Botkin Municipal Clinical Hospital of the Moscow Healthcare Department, Moscow, Russia
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13
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Kim SH, Oh CH, Lee JM, Choi SJ, Choi HS, Kim ES, Keum B, Jeen YT, Chun HJ, Lee HS, Kim CD. Early malfunction of a biliary self-expandable metal stent with an antireflux valve: A case report. Medicine (Baltimore) 2020; 99:e19750. [PMID: 32311973 PMCID: PMC7220473 DOI: 10.1097/md.0000000000019750] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022] Open
Abstract
RATIONALE Biliary drainage is essential to resolve jaundice in patients with malignant biliary obstruction. Recently, a biliary self-expandable metal stent (SEMS) with an antireflux valve was developed to prevent enteric-biliary reflux. Its antireflux valve was made of expanded polytetrafluoroethylene (ePTFE), a biostable and biocompatible material. Changes of the ePTFE membrane of medical devices are rarely reported in clinical practice. PATIENT CONCERNS A 59-year-old woman was admitted with a complaint of jaundice. Around 1 month before, she underwent endoscopic biliary stenting using a SEMS with an antireflux valve. DIAGNOSIS Acute cholangitis due to stent clogging was detected on abdominal computed tomography. INTERVENTIONS Endoscopic retrograde cholangiopancreatography and removal of the SEMS with deformity were performed. OUTCOMES The obstructive jaundice was rapidly resolved after the removal of the clogged stent. LESSONS Although the ePTFE membrane is widely used to make medical devices, unexpected changes could occur after the membrane is exposed to bile juice in the duodenum. When performing biliary stenting using a SEMS with an antireflux valve, both the risk of early malfunction and the benefit of the antireflux effect should be considered.
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Affiliation(s)
- Sang Hoon Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Chi Hyuk Oh
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, Korea
| | - Jae Min Lee
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Seong Ji Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Hyuk Soon Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Eun Sun Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Bora Keum
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Yoon Tae Jeen
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Hoon Jai Chun
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Hong Sik Lee
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
| | - Chang Duck Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine
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14
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Tringali A. Endoscopic Management in Malignant Biliary Strictures: Tips and Tricks. ENDOTHERAPY IN BILIOPANCREATIC DISEASES: ERCP MEETS EUS 2020:431-461. [DOI: 10.1007/978-3-030-42569-2_40] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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15
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Hamada T, Isayama H, Nakai Y, Iwashita T, Ito Y, Mukai T, Yagioka H, Saito T, Togawa O, Ryozawa S, Hirano K, Mizuno S, Yamamoto N, Kogure H, Yasuda I, Koike K. Antireflux covered metal stent for nonresectable distal malignant biliary obstruction: Multicenter randomized controlled trial. Dig Endosc 2019; 31:566-574. [PMID: 30803046 DOI: 10.1111/den.13381] [Citation(s) in RCA: 31] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/20/2018] [Accepted: 02/22/2019] [Indexed: 12/30/2022]
Abstract
BACKGROUND AND AIM An antireflux metal stent (ARMS) for nonresectable distal malignant biliary obstruction (MBO) may prevent recurrent biliary obstruction (RBO) as a result of duodenobiliary reflux and prolong time to RBO (TRBO). Superiority of ARMS over conventional covered self-expandable metal stents (SEMS) has not been fully examined. METHODS We conducted a multicenter randomized controlled trial to examine whether TRBO of an ARMS with a funnel-shaped valve was longer than that of a covered SEMS in SEMS-naïve patients. We enrolled 104 patients (52 patients per arm) at 11 hospitals in Japan. Secondary outcomes included causes of RBO, adverse events, and patient survival. RESULTS TRBO did not differ significantly between the ARMS and covered SEMS groups (median, 251 vs 351 days, respectively; P = 0.11). RBO as a result of biliary sludge or food impaction was observed in 13% and 9.8% of patients who received an ARMS and covered SEMS, respectively (P = 0.83). ARMS was associated with a higher rate of stent migration compared with the covered SEMS (31% vs 12%, P = 0.038). Overall rates of adverse events were 20% and 18% in the ARMS and covered SEMS groups, respectively (P = 0.97). No significant between-group difference in patient survival was observed (P = 0.26). CONCLUSIONS The current ARMS was not associated with longer TRBO compared with the covered SEMS. Modifications including addition of an anti-migration system are required to use the current ARMS as first-line palliative treatment of distal MBO (UMIN-CTR clinical trial registration number: UMIN000014784).
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Affiliation(s)
- Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.,Department of Oncologic Pathology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, USA
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.,Department of Gastroenterology, Graduate School of Medicine, Juntendo University
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Takuji Iwashita
- First Department of Internal Medicine, Gifu University Hospital
| | - Yukiko Ito
- Department of Gastroenterology, Japanese Red Cross Medical Center
| | - Tsuyoshi Mukai
- Department of Gastroenterology, Gifu Municipal Hospital, Gifu
| | - Hiroshi Yagioka
- Department of Gastroenterology, Tokyo Metropolitan Police Hospital
| | - Tomotaka Saito
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.,Department of Gastroenterology, JR Tokyo General Hospital
| | - Osamu Togawa
- Department of Gastroenterology, Kanto Central Hospital
| | - Shomei Ryozawa
- Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama
| | - Kenji Hirano
- Department of Gastroenterology, JCHO Tokyo Takanawa Hospital
| | - Suguru Mizuno
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo.,Department of Gastroenterology, Toshiba General Hospital, Tokyo
| | | | - Hirofumi Kogure
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
| | - Ichiro Yasuda
- Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kanagawa, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
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16
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Kwon CI. [Relief of Obstruction in the Management of Pancreatic Cancer]. THE KOREAN JOURNAL OF GASTROENTEROLOGY 2019; 74:69-80. [PMID: 31438658 DOI: 10.4166/kjg.2019.74.2.69] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/15/2019] [Revised: 07/01/2019] [Accepted: 07/05/2019] [Indexed: 11/03/2022]
Abstract
Pancreatic cancer is a major cause of cancer-related mortality and morbidity, and its incidence is increasing as the population is aging. On the other hand, significant improvement in the prognosis has not occurred. The absence of early diagnosis means that many patients are diagnosed only when they develop symptoms, such as jaundice, due to a biliary obstruction. The role of endoscopy in multidisciplinary care for patients with pancreatic cancer continues to evolve. Controversy remains regarding the best preoperative biliary drainage in patients with surgically resectable pancreatic head cancer. In general, patients undergoing a surgical resection usually do not require preoperative biliary drainage unless they have cholangitis or receive neoadjuvant chemotherapy. If biliary drainage is performed prior to surgery, the patient's condition and a multidisciplinary approach should be considered. With the increasing life expectancy of patients with pancreatic cancer, the need for more long-time biliary drainage or pre-operative biliary drainage is also increasing. Strong evidence of endoscopic retrograde cholangiopancreatography (ERCP) as a first-line and essential treatment for biliary decompression has been provided. On the other hand, the use of endoscopic ultrasound-guided biliary drainage as well as percutaneous biliary drainage has been also recommended. During ERCP, self-expandable metal stent could be recommended instead of a plastic stent for the purpose of long stent patency and minimizing stent-induced complications. In this review, several points of view regarding the relief of obstruction in patients with pancreatic cancer, and optimal techniques are being discussed.
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Affiliation(s)
- Chang-Il Kwon
- Digestive Disease Center, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea
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17
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Kwon CI, Moon JP, Yun H, Jeong S, Koh DH, Lee WJ, Ko KH, Kang DH. Evaluation of valve function in antireflux biliary metal stents. BMC Gastroenterol 2018; 18:150. [PMID: 30340463 PMCID: PMC6194677 DOI: 10.1186/s12876-018-0878-8] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2018] [Accepted: 10/02/2018] [Indexed: 02/08/2023] Open
Abstract
Background To overcome duodenobiliary reflux induced by biliary stents, antireflux valve (ARV) biliary stents have been developed and showed improvement in stent patency. However, negative study results have also been reported because stent patency may be decreased by the malfunction of ARV itself. Given such mixed results, the true efficacy of ARV remains unknown and the mechanism of its dysfunction needs to be clearly elucidated. The aim of this study was to investigate the exact mechanism of ARV dysfunction using in vitro phantom models. Methods Two experimental models were designed to evaluate two important environmental factors suspected to cause ARV malfunction, i.e. bile flow and pH. Three types of ARV metal stents from different companies were used for the experiments: a funnel type ARV, a windsock type ARV, and a wine glass-shaped ARV. Ten stents of each type were tested (five stents in the bile flow phantom model, and another five stents in the duodenal pH environmental model). To determine ARV malfunction, ARV-induced flow resistance was measured using a custom-made testing device. All stents from the two models were removed every 2 weeks for 12 weeks after stent insertion and were evaluated on morphological and functional changes of the ARV. Results Only ARV of wine glass-shaped ARV was morphologically changed due to silicone bond detachment in the bile flow model. All types of ARV were morphologically changed in the pH model. The morphological changes of ARV influenced the flow resistance. The antegrade pressure gradients were increased over time in the pH model (p < 0.05). Conclusions Morphological change of the ARVs may induce dysfunction of ARV metal stents, which is mainly due to duodenal pH environment. In the future, development of new ARV that is not affected by duodenal environmental factors can be expected to improve stent patency. Electronic supplementary material The online version of this article (10.1186/s12876-018-0878-8) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Chang-Il Kwon
- Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea
| | - Jong Pil Moon
- Interventional Research Center, M.I.Tech, Co. Ltd., Pyeongtaek, Republic of Korea
| | - Ho Yun
- Interventional Research Center, M.I.Tech, Co. Ltd., Pyeongtaek, Republic of Korea
| | - Seok Jeong
- Division of Gastroenterology, Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea
| | - Dong Hee Koh
- Division of Gastroenterology, Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University School of Medicine, Hwaseong, Republic of Korea
| | - Woo Jung Lee
- Division of Gastroenterology, Department of Internal Medicine, Temple University Hospital, Philadelphia, PA, USA
| | - Kwang Hyun Ko
- Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea
| | - Dae Hwan Kang
- Department of Internal Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
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18
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Gwon DI, Ko GY, Kim JW, Ko HK, Yoon HK, Sung KB. Double-Stent System with Long Duodenal Extension for Palliative Treatment of Malignant Extrahepatic Biliary Obstructions: A Prospective Study. Korean J Radiol 2018. [PMID: 29520180 PMCID: PMC5840051 DOI: 10.3348/kjr.2018.19.2.230] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
Objective To investigate the technical safety and clinical efficacy of a double-stent system with long duodenal extension in patients with malignant extrahepatic biliary obstruction. Materials and Methods This prospective study enrolled 48 consecutive patients (31 men, 17 women; mean age, 61 years; age range, 31–77 years) with malignant extrahepatic biliary obstructions from May 2013 to December 2015. All patients were treated with a double-stent system with long duodenal covered extension (16 cm or 21 cm). Results The stents were successfully placed in all 48 patients. There were five (10.4%) procedure-related complications. Minor complications were self-limiting hemobilia (n = 2). Major complications included acute pancreatitis (n = 1) and acute cholecystitis (n = 2). Successful internal drainage was achieved in 42 (87.5%) patients. Median patient survival and stent patency times were 92 days (95% confidence interval [CI], 61–123 days) and 83 days (95% CI, 46–120 days), respectively. Ten (23.8%) of the 42 patients presented with stent occlusion due to food impaction with biliary sludge, and required repeat intervention. Stent occlusion was more frequent in metastatic gastric cancer patients with pervious gastrectomy, but did not reach statistical significance (p = 0.069). Conclusion Percutaneous placement of a double-stent system with long duodenal extension is feasible and safe. However, this stent system does not completely prevent stent occlusion caused by food reflux.
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Affiliation(s)
- Dong Il Gwon
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
| | - Gi-Young Ko
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
| | - Jong Woo Kim
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
| | - Heung Kyu Ko
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
| | - Hyun-Ki Yoon
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
| | - Kyu-Bo Sung
- Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul 05505, Korea
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Antireflux Metal Stent for Initial Treatment of Malignant Distal Biliary Obstruction. Gastroenterol Res Pract 2018; 2018:3805173. [PMID: 29643916 PMCID: PMC5831319 DOI: 10.1155/2018/3805173] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2017] [Accepted: 01/02/2018] [Indexed: 12/14/2022] Open
Abstract
Objectives To compare the use of an antireflux metal stent (ARMS) with that of a conventional covered self-expandable metal stent (c-CSEMS) for initial stenting of malignant distal biliary obstruction (MDBO). Materials and Methods We retrospectively investigated 59 consecutive patients with unresectable MDBO undergoing initial endoscopic biliary drainage. ARMS was used in 32 patients and c-CSEMS in 27. Technical success, functional success, complications, causes of recurrent biliary obstruction (RBO), time to RBO (TRBO), and reintervention were compared between the groups. Results Stent placement was technically successful in all patients. There were no significant intergroup differences in functional success (ARMS [96.9%] versus c-CSEMS [96.2%]), complications (6.2 versus 7.4%), and RBO (48.4 versus 42.3%). Food impaction was significantly less frequent for ARMS than for c-CSEMS (P = 0.037), but TRBO did not differ significantly between the groups (log-rank test, P = 0.967). The median TRBO was 180.0 [interquartile range (IQR), 114.0–349.0] days for ARMS and 137.0 [IQR, 87.0–442.0] days for c-CSEMS. In both groups, reintervention for RBO was successfully completed in all patients thus treated. Conclusion ARMS offers no advantage for initial stent placement, but food impaction is significantly prevented by the antireflux valve.
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20
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He K, Miao Y, Zhao L, Fan Z, Liu L. Antireflux stent for distal malignant biliary obstruction: some inspiration from a randomized controlled trial. Gastrointest Endosc 2017; 85:462. [PMID: 28089040 DOI: 10.1016/j.gie.2016.07.009] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/28/2016] [Accepted: 07/03/2016] [Indexed: 02/08/2023]
Affiliation(s)
- Kexin He
- Digestive Endoscopy Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China
| | - Yuxia Miao
- Digestive Endoscopy Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China
| | - Lili Zhao
- Digestive Endoscopy Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China
| | - Zhining Fan
- Digestive Endoscopy Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China
| | - Li Liu
- Digestive Endoscopy Center, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China
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21
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Hamada T, Isayama H, Nakai Y, Togawa O, Takahara N, Uchino R, Mizuno S, Mohri D, Yagioka H, Kogure H, Matsubara S, Yamamoto N, Ito Y, Tada M, Koike K. Antireflux Metal Stent as a First-Line Metal Stent for Distal Malignant Biliary Obstruction: A Pilot Study. Gut Liver 2017; 11:142-148. [PMID: 27282268 PMCID: PMC5221872 DOI: 10.5009/gnl15579] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/12/2015] [Revised: 12/08/2015] [Accepted: 01/12/2016] [Indexed: 12/27/2022] Open
Abstract
BACKGROUND/AIMS In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent. METHODS Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement. RESULTS In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced nonocclusion cholangitis. CONCLUSIONS The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.
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Affiliation(s)
- Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
- Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo,
Japan
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Osamu Togawa
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Naminatsu Takahara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Rie Uchino
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Suguru Mizuno
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Dai Mohri
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Hiroshi Yagioka
- Department of Gastroenterology, Tokyo Metropolitan Police Hospital, Tokyo,
Japan
| | - Hirofumi Kogure
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Saburo Matsubara
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Natsuyo Yamamoto
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Yukiko Ito
- Department of Gastroenterology, Japanese Red Cross Medical Center, Tokyo,
Japan
| | - Minoru Tada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo,
Japan
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22
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Boulay BR, Birg A. Malignant biliary obstruction: From palliation to treatment. World J Gastrointest Oncol 2016; 8:498-508. [PMID: 27326319 PMCID: PMC4909451 DOI: 10.4251/wjgo.v8.i6.498] [Citation(s) in RCA: 61] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/17/2015] [Revised: 11/04/2015] [Accepted: 04/22/2016] [Indexed: 02/05/2023] Open
Abstract
Malignant obstruction of the bile duct from cholangiocarcinoma, pancreatic adenocarcinoma, or other tumors is a common problem which may cause debilitating symptoms and increase the risk of subsequent surgery. The optimal treatment - including the decision whether to treat prior to resection - depends on the type of malignancy, as well as the stage of disease. Preoperative biliary drainage is generally discouraged due to the risk of infectious complications, though some situations may benefit. Patients who require neoadjuvant therapy will require decompression for the prolonged period until attempted surgical cure. For pancreatic cancer patients, self-expanding metallic stents are superior to plastic stents for achieving lasting decompression without stent occlusion. For cholangiocarcinoma patients, treatment with percutaneous methods or nasobiliary drainage may be superior to endoscopic stent placement, with less risk of infectious complications or failure. For patients of either malignancy who have advanced disease with palliative goals only, the choice of stent for endoscopic decompression depends on estimated survival, with plastic stents favored for survival of < 4 mo. New endoscopic techniques may actually extend stent patency and patient survival for these patients by achieving local control of the obstructing tumor. Both photodynamic therapy and radiofrequency ablation may play a role in extending survival of patients with malignant biliary obstruction.
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23
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Kwon CI, Lehman GA. Mechanisms of Biliary Plastic Stent Occlusion and Efforts at Prevention. Clin Endosc 2016; 49:139-46. [PMID: 27000422 PMCID: PMC4821514 DOI: 10.5946/ce.2016.024] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2016] [Revised: 02/02/2016] [Accepted: 02/02/2016] [Indexed: 12/17/2022] Open
Abstract
Biliary stenting via endoscopic retrograde cholangiopancreatography has greatly improved the quality of patient care over the last 30 years. Plastic stent occlusion limits the life span of such stents. Attempts to improve plastic stent patency duration have mostly failed. Metal stents (self-expandable metal stents [SEMSs]) have therefore replaced plastic stents, especially for malignant biliary strictures. SEMS are at least 10 times more expensive than plastic stents. In this focused review, we will discuss basic mechanisms of plastic stent occlusion, along with a systematic summary of previous efforts and related studies to improve stent patency and potential new techniques to overcome existing limitations.
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Affiliation(s)
- Chang-Il Kwon
- Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
| | - Glen A Lehman
- Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, IN, USA
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24
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Hamada T, Nakai Y, Isayama H, Koike K. Against duodenobiliary reflux: implications from a randomized controlled trial. Gastrointest Endosc 2016; 83:673-4. [PMID: 26897052 DOI: 10.1016/j.gie.2015.09.042] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/30/2015] [Accepted: 09/30/2015] [Indexed: 12/11/2022]
Affiliation(s)
- Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Yousuke Nakai
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Hiroyuki Isayama
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
| | - Kazuhiko Koike
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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25
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Lee YN, Moon JH, Choi HJ. Response. Gastrointest Endosc 2016; 83:674-5. [PMID: 26897053 DOI: 10.1016/j.gie.2015.11.022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2015] [Accepted: 11/16/2015] [Indexed: 02/08/2023]
Affiliation(s)
- Yun Nah Lee
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChungHyang University School of Medicine, Bucheon and Seoul, Korea
| | - Jong Ho Moon
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChungHyang University School of Medicine, Bucheon and Seoul, Korea
| | - Hyun Jong Choi
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChungHyang University School of Medicine, Bucheon and Seoul, Korea
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26
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Ferreira R, Loureiro R, Nunes N, Santos AA, Maio R, Cravo M, Duarte MA. Role of endoscopic retrograde cholangiopancreatography in the management of benign biliary strictures: What’s new? World J Gastrointest Endosc 2016; 8:220-231. [PMID: 26962404 PMCID: PMC4766255 DOI: 10.4253/wjge.v8.i4.220] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2015] [Revised: 08/18/2015] [Accepted: 12/15/2015] [Indexed: 02/05/2023] Open
Abstract
Benign biliary strictures comprise a heterogeneous group of diseases. The most common strictures amenable to endoscopic treatment are post-cholecystectomy, post-liver transplantation, related to primary sclerosing cholangitis and to chronic pancreatitis. Endoscopic treatment of benign biliary strictures is widely used as first line therapy, since it is effective, safe, noninvasive and repeatable. Endoscopic techniques currently used are dilation, multiple plastic stents insertion and fully covered self-expandable metal stents. The main indication for dilation alone is primary sclerosing cholangitis related strictures. In the vast majority of the remaining cases, temporary placement of multiple plastic stents with/without dilation is considered the treatment of choice. Although this approach is effective, it requires multiple endoscopic sessions due to the short duration of stent patency. Fully covered self-expandable metal stents appear as a good alternative to plastic stents, since they have an increased radial diameter, longer stent patency, easier insertion technique and similar efficacy. Recent advances in endoscopic technique and various devices have allowed successful treatment in most cases. The development of novel endoscopic techniques and devices is still ongoing.
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Abstract
Many advances have been achieved in biliary stenting over the past 30 years. Endoscopic stent placement has become the primary management therapy to relieve obstruction in patients with benign or malignant biliary tract diseases. Compared with plastic stents, a self-expandable metallic stent (SEMS) has been used for management in patients with malignant strictures because of a larger lumen and longer stent patency. Recently, SEMS has been used for various benign biliary strictures and leaks. In this article, we briefly review the characteristics of SEMS as well as complications of stent placement. We review the current guidelines for managing malignant and benign biliary obstructions. Recent developments in biliary stenting are also discussed.
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Affiliation(s)
- Hyeong Seok Nam
- Department of Internal Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
| | - Dae Hwan Kang
- Department of Internal Medicine, Pusan National University School of Medicine and Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
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28
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Antireflux metallic biliary stents: Where do we stand? Gastrointest Endosc 2016; 83:413-5. [PMID: 26773637 DOI: 10.1016/j.gie.2015.10.016] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2015] [Accepted: 10/14/2015] [Indexed: 12/11/2022]
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29
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Leong QW, Shen ML, Au KW, Luo D, Lau JY, Wu JC, Chan FK, Sung JJ. A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis. Gastrointest Endosc 2016; 83:387-93. [PMID: 26024583 DOI: 10.1016/j.gie.2015.04.027] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2014] [Accepted: 04/15/2015] [Indexed: 12/11/2022]
Abstract
BACKGROUND There is as yet no ideal design of a plastic biliary stent with the longest patency period. OBJECTIVE To study the safety and effective patency period of a new plastic antireflux biliary stent in the clinical setting. DESIGN We conducted a prospective, randomized trial to compare the patency of 2 similar plastic biliary stents, one of which has an antiduodenobiliary reflux property. SETTING The study was conducted at 2 separate tertiary centers in 2 countries. PATIENTS Patients with inoperable distal malignant biliary obstruction were recruited. INTERVENTIONS One of the 2 types of plastic stents under study was randomly chosen and inserted in the common bile duct of the study subjects. The subjects were followed until the end of study or occlusion occurrence. MAIN OUTCOME MEASUREMENTS Our primary endpoint was the time to stent occlusion in days, with stent-related adverse events and all-cause mortality the secondary endpoints. RESULTS A total of 16 subjects were recruited for the study; 7 were allocated to group A (ordinary Tannenbaum stent) and 9 to group B (antireflux biliary stent). Five of 7 subjects (71%) in group B had stent occlusion within 8 days, and the primary end point was reached in all 7 subjects within 30 days, whereas the primary endpoint was not reached within 30 days in any of the subjects in group A. Our data showed a significantly shorter stent patency period in group B compared with group A (P < .003). LIMITATIONS Small sample size. CONCLUSION Routine use of antireflux plastic biliary stents in the palliative management of malignant biliary obstructions cannot be recommended at present. (Clinical trial registration number: NCT01142921.).
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Affiliation(s)
| | - Mira L Shen
- Tan Tock Seng Hospital, Republic of Singapore
| | - Kim W Au
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
| | - Derek Luo
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
| | - James Y Lau
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
| | - Justin C Wu
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
| | - Francis K Chan
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
| | - Joseph J Sung
- Institute of Digestive Disease, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong SAR
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30
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Lee YN, Moon JH, Choi HJ, Choi MH, Lee TH, Cha SW, Cho YD, Choi SY, Lee HK, Park SH. Effectiveness of a newly designed antireflux valve metal stent to reduce duodenobiliary reflux in patients with unresectable distal malignant biliary obstruction: a randomized, controlled pilot study (with videos). Gastrointest Endosc 2016; 83:404-12. [PMID: 26385187 DOI: 10.1016/j.gie.2015.08.084] [Citation(s) in RCA: 49] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2015] [Accepted: 08/30/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS In patients with unresectable distal malignant biliary obstruction (MBO), endoscopic biliary drainage by using self-expandable metal stents (SEMSs) is an established palliative treatment. However, the placement of a SEMS across the major duodenal papilla prompts reflux of duodenal contents. In this study, we evaluated stent patency and duodenobiliary reflux caused by a newly developed SEMS with an antireflux valve (ARV) of the windsock type, compared with a conventional covered SEMS (cSEMS) in patients with MBO. METHODS Between January 2013 and September 2014, 77 patients with unresectable distal MBO were assigned randomly to groups treated with an ARV metal stent (ARVMS) group (39 patients) or a conventional cSEMS group (38 patients). In all patients, a barium meal examination was performed to evaluate reflux of barium within the SEMS and intrahepatic bile ducts. The primary outcome was stent patency duration. Secondary outcomes were the rates of technical and clinical success, duodenobiliary reflux on barium meal examination, factors causing stent dysfunction, overall patient survival, and adverse events. RESULTS Stent placement was technically successful in all patients. The clinical success rates were not statistically significantly different between the ARVMS and cSEMS groups (97.4% vs 97.4%, P = 1.000). Overall reflux of barium was significantly lower in the ARVMS group than the cSEMS group (7.7% vs 100%, P < .001). The cumulative duration of stent patency was significantly longer in the ARVMS group than in the cSEMS group (median ± SD, 407 ± 92 vs 220 ± 37 days; P = .013). On multivariate analysis, complete duodenobiliary reflux (odds ratio, 5.7, P = .004) and ampullary cancer (odds ratio, 8.98, P = .012) were identified as independent risk factors for stent dysfunction. There was no significant difference between the 2 groups in overall patient survival or in the incidence of adverse events. CONCLUSIONS The newly developed ARVMS seemed to have a superior duration of stent patency and comparable safety compared with the cSEMS. In addition, the duodenobiliary reflux related to stent dysfunction can be prevented effectively by ARVMS. Further randomized, controlled trials using large numbers of subjects are required to confirm the benefit of SEMSs with antireflux function. (Clinical trial registration number: UMIN000012734.).
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Affiliation(s)
- Yun Nah Lee
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Jong Ho Moon
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Hyun Jong Choi
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Moon Han Choi
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Tae Hoon Lee
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Sang-Woo Cha
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Young Deok Cho
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Seo-Youn Choi
- Department of Radiology, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Hae Kyung Lee
- Department of Radiology, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
| | - Sang-Heum Park
- Digestive Disease Center and Research Institute, Department of Internal Medicine, SoonChunHyang University School of Medicine, Bucheon and Seoul, South Korea
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31
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Abstract
Endoscopic stenting is increasingly being used in the management of gastrointestinal luminal obstruction, and has become the current treatment of choice for the palliation of blockage caused by malignant or benign growths. A variety of stents have been developed to enhance the efficacy of the procedure, and improvements are ongoing. In this article, we review the history of, and recent advances in, gastrointestinal stenting. We describe the rationale behind the design as well as the resulting outcome for each stent type.
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Affiliation(s)
- Jin-Seok Park
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
| | - Seok Jeong
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. ; National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea
| | - Don Haeng Lee
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. ; National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea. ; Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea
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32
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Stents with specialized functions: drug-eluting stents and stents with antireflux devices. GASTROINTESTINAL INTERVENTION 2015. [DOI: 10.1016/j.gii.2015.03.004] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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33
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Hamada T, Isayama H, Nakai Y, Togawa O, Kogure H, Takahara N, Mohri D, Sasaki T, Matsubara S, Yamamoto N, Hirano K, Tada M, Koike K. Antireflux metal stent with an antimigration system for distal malignant biliary obstruction: a feasibility pilot study. Surg Laparosc Endosc Percutan Tech 2015; 25:212-217. [PMID: 25856131 DOI: 10.1097/sle.0000000000000149] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
An antireflux metal stent (ARMS) for distal malignant biliary obstruction has been reported to be useful, but the effectiveness of a flared-end structure to prevent migration on ARMS remains unclear. To evaluate the feasibility of a newly designed ARMS with both ends flared, 8 patients with covered metal stent occlusion due to sludge or food impaction were enrolled. ARMS were placed successfully after endoscopic removal of the occluded stents in all patients, and no procedure-related complication was observed. The median time to recurrent biliary obstruction was 71 days. ARMS occlusion occurred in 3 (38%) patients (sludge in 2 patients and hemobilia in 1). ARMS migration occurred in 1 (13%) patient. As a late complication, cholecystitis occurred in 1 (13%) patient. In conclusion, our newly designed ARMS with an antimigration system was technically feasible and safe, and a further investigation is warranted to evaluate the effectiveness of the current antimigration system.
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Affiliation(s)
- Tsuyoshi Hamada
- Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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34
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Park JS, Jeong S, Lee DH. Recent Advances in Gastrointestinal Stent Development. Clin Endosc 2015; 48:209-15. [PMID: 26064820 PMCID: PMC4461664 DOI: 10.5946/ce.2015.48.3.209] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2015] [Accepted: 05/06/2015] [Indexed: 12/17/2022] Open
Abstract
Endoscopic stenting is increasingly being used in the management of gastrointestinal luminal obstruction, and has become the current treatment of choice for the palliation of blockage caused by malignant or benign growths. A variety of stents have been developed to enhance the efficacy of the procedure, and improvements are ongoing. In this article, we review the history of, and recent advances in, gastrointestinal stenting. We describe the rationale behind the design as well as the resulting outcome for each stent type.
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Affiliation(s)
- Jin-Seok Park
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea
| | - Seok Jeong
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. ; National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea
| | - Don Haeng Lee
- Digestive Disease Center, Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea. ; National Center of Efficacy Evaluation for the Development of Health Products Targeting Digestive Disorders (NCEED), Incheon, Korea. ; Utah-Inha DDS & Advanced Therapeutics Research Center, Incheon, Korea
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35
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Huang X, Shen L, Jin Y, Chen L, Zhou D, Xu G, Ni C. Comparison of uncovered stent placement across versus above the main duodenal papilla for malignant biliary obstruction. J Vasc Interv Radiol 2015; 26:432-7. [PMID: 25595724 DOI: 10.1016/j.jvir.2014.11.008] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2014] [Revised: 11/02/2014] [Accepted: 11/04/2014] [Indexed: 01/17/2023] Open
Abstract
PURPOSE To evaluate the differences in efficiency and complications of metal stent insertion across versus above the main duodenal papilla (MDP) in patients with malignant obstruction of the common bile duct (CBD). MATERIALS AND METHODS Records of 98 consecutive patients who underwent stent insertion for malignant CBD obstruction between 2004 and 2010 were retrospectively reviewed. Fifty-one patients (group 1) and 47 patients (group 2) were treated with stent insertion across and above the MDP, respectively. Primary stent patency, overall survival, complications, and changes in serum bilirubin level following stent insertion were assessed. RESULTS Infection appeared in 12 and four patients, respectively, in groups 1 and 2. The respective mean primary stent patency times were 307.8 days ± 20.2 and 490.7 days ± 40.7, and mean survival times were 245.1 days ± 17.4 and 286.3 days ± 20.2. Bilirubin reduction rates were 55.7% ± 16.6 and 61.1% ± 13.7 at 1 week and 84.2% ± 5.7 and 86.2% ± 5.7 at 1 month in groups 1 and 2, respectively. In group 2, the rate of infection was significantly lower (P = .044) and primary stent patency was longer (P = .019). However, there was no significant difference between groups in survival time (P = .074) or bilirubin reduction rate at 1 week (P = .083) or 1 month (P = .082). CONCLUSIONS Bile stent insertion above the MDP may achieve longer stent patency and a lower infection rate compared with placement across the MDP. For patients with malignant CBD obstruction, biliary stents should be placed above the papilla if papillary lesions are not invaded.
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Affiliation(s)
- Xianchen Huang
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Liming Shen
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Yiqi Jin
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Lei Chen
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Dayong Zhou
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Guoxiong Xu
- Department of Vascular Surgery and Interventional Radiology, Nanjing Medical University Affiliated Suzhou Hospital, 188 Shizi St., Suzhou 215006, China
| | - Caifang Ni
- Department of Interventional Radiology, First Affiliated Hospital of Soochow University, 188 Shizi St., Suzhou 215006, China..
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36
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Park AW. Covered metallic stents in malignant common bile duct obstruction: to use or not to use--that is the question! J Vasc Interv Radiol 2014; 25:1920-1. [PMID: 25457140 DOI: 10.1016/j.jvir.2014.09.008] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/12/2014] [Revised: 09/12/2014] [Accepted: 09/15/2014] [Indexed: 10/24/2022] Open
Affiliation(s)
- Auh Whan Park
- Vascular and Interventional Radiology Section, University of Virginia Health System, 1215 Lee St., Charlottesville, VA 22908.
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37
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Boulay BR, Parepally M. Managing malignant biliary obstruction in pancreas cancer: choosing the appropriate strategy. World J Gastroenterol 2014; 20:9345-53. [PMID: 25071329 PMCID: PMC4110566 DOI: 10.3748/wjg.v20.i28.9345] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/29/2013] [Revised: 01/30/2014] [Accepted: 03/12/2014] [Indexed: 02/06/2023] Open
Abstract
Most patients with pancreatic cancer develop malignant biliary obstruction. Treatment of obstruction is generally indicated to relieve symptoms and improve morbidity and mortality. First-line therapy consists of endoscopic biliary stent placement. Recent data comparing plastic stents to self-expanding metallic stents (SEMS) has shown improved patency with SEMS. The decision of whether to treat obstruction and the means for doing so depends on the clinical scenario. For patients with resectable disease, preoperative biliary decompression is only indicated when surgery will be delayed or complications of jaundice exist. For patients with locally advanced disease, self-expanding metal stents are superior to plastic stents for long-term patency. For patients with advanced disease, the choice of metallic or plastic stent depends on life expectancy. When endoscopic stent placement fails, percutaneous or surgical treatments are appropriate. Endoscopic therapy or surgical approach can be used to treat concomitant duodenal and biliary obstruction.
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Yu H, Miao L. Biliary stenting for cholangiocarcinoma: An update. Shijie Huaren Xiaohua Zazhi 2014; 22:648-653. [DOI: 10.11569/wcjd.v22.i5.648] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
Cholangiocarcinoma (bile duct cancer) is the most common malignant tumor of the biliary tree. This devastating malignancy presents late, and is notoriously difficult to diagnose, thus resulting a high mortality. The majority of cholangiocarcinoma patients present with an unresectable disease, and survive less than 12 mo following diagnosis. Biliary stent placement is an effective palliative therapy for malignant biliary obstruction, which can significantly improve the quality of life, and extend the survival time of patients. Different biliary stent placement methods would closely affect the prognosis of patients. The purpose of this article is to review the treatment efficacy, insertion paths and types of biliary stents. This paper also covers emerging biliary stents including drug stents, and biliary stent combination local therapy.
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Kwon CI, Ko KH, Hahm KB, Kang DH. Functional self-expandable metal stents in biliary obstruction. Clin Endosc 2013; 46:515-21. [PMID: 24143314 PMCID: PMC3797937 DOI: 10.5946/ce.2013.46.5.515] [Citation(s) in RCA: 28] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/04/2013] [Revised: 06/28/2013] [Accepted: 06/29/2013] [Indexed: 12/20/2022] Open
Abstract
Biliary stents are widely used not only for palliative treatment of malignant biliary obstruction but also for benign biliary diseases. Each plastic stent or self-expandable metal stent (SEMS) has its own advantages, and a proper stent should be selected carefully for individual condition. To compensate and overcome several drawbacks of SEMS, functional self-expandable metal stent (FSEMS) has been developed with much progress so far. This article looks into the outcomes and defects of each stent type for benign biliary stricture and describes newly introduced FSEMSs according to their functional categories.
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Affiliation(s)
- Chang-Il Kwon
- Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea
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