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Xing L, Liu YT, Ye X, Wang TT, Wu J, Xia MX, Hu B, Gao DJ. Long slim versus conventional self-expandable metallic stent in bilateral endoscopic side-by-side deployment for unresectable malignant hilar biliary obstruction. Gastrointest Endosc 2025:S0016-5107(25)00073-2. [PMID: 39924062 DOI: 10.1016/j.gie.2025.01.040] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2024] [Revised: 12/26/2024] [Accepted: 01/31/2025] [Indexed: 02/11/2025]
Abstract
BACKGROUND AND AIMS The goal of this study was to compare the advantages of long slim metal stents (LSMSs) versus conventional metal stents in bilateral endoscopic side-by-side (SBS) deployment for malignant hilar biliary obstruction (MHBO). METHODS A total of 140 consecutive patients with MHBO treated by endoscopic bilateral SBS deployment at a high-volume tertiary referral center were analyzed retrospectively; this included 50 patients in the LSMS group and the other 90 patients in the conventional SBS group as control. Propensity score matching at a 1:2 ratio was used to reduce selection bias. The primary outcome was stent patency. RESULTS After propensity score matching, no significant difference was observed in stent patency (267 vs 268 days; P = .923) or overall survival (225 vs 211 days; P = .883) between the 2 groups. The technical success rate was 100% in both groups, and the clinical success rate was 91.1% in the LSMS group and 92.9% in the control group (P = .735). Early and late adverse events were similar (24.4% vs 34.3%, P = .423; 42.2% vs 38.6%, P = .697); the procedure time and bilateral metal stenting time in the LSMS group were significantly shorter (41.0 minutes vs 57.5 minutes, P = .000; 19.0 minutes vs 28.5 minutes, P = .000). The success rate of endoscopic bilateral revisionary stent insertion in the LSMS group was also higher (100% vs 33.3%; P = .000). CONCLUSIONS Bilateral LSMS placement is a viable option for patients with MHBO. It includes advantages of less operative difficulty and easier future re-intervention over conventional SBS stenting.
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Affiliation(s)
- Ling Xing
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Yan-Ting Liu
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Xin Ye
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Tian-Tian Wang
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Jun Wu
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Ming-Xing Xia
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Bing Hu
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China
| | - Dao-Jian Gao
- Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Naval Medical University, Shanghai, China.
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Tsauo J, Fu Y, Liu Y, Zhang X, Zhao H, Li X. Characteristics of four commonly used self-expanding biliary stents: an in vitro study. Eur Radiol Exp 2024; 8:24. [PMID: 38369648 PMCID: PMC10874915 DOI: 10.1186/s41747-024-00425-5] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2023] [Accepted: 12/19/2023] [Indexed: 02/20/2024] Open
Abstract
BACKGROUND Knowledge of the characteristics of self-expanding metal stents (SEMSs) is essential during selection process to ensure the best therapeutic outcomes for patients with malignant biliary obstruction. The aim of this study was to evaluate the characteristics of four commonly used SEMSs. METHODS This in vitro study analyzed the radial force (RF), crush resistance (CR), axial force (AF), conformability, surface quality, foreshortening, and radiopacity of the following SEMSs: uncovered Wallflex™, EGIS single bare, Zilver 635®, and E-Luminexx™. Two samples of each SEMS type were included in this study, all having identical specifications with a diameter of 10 mm and a length of 6 cm. One sample from each type was analyzed for surface quality, followed by CR, conformability, and foreshortening. The other sample was analyzed for radiopacity, followed by RF and AF. RESULTS The uncovered Wallflex™ exhibited low RF, high CR, high AF, good conformability, poor surface quality, high foreshortening, and good radiopacity. The EGIS single bare demonstrated high RF, high CR, low AF, moderate conformability, good surface quality, high foreshortening, and poor radiopacity. The Zilver 635® displayed moderate RF, low CR, low AF, moderate conformability, moderate surface quality, no foreshortening, and good radiopacity. The E-Luminexx™ showed high RF, moderate CR, high AF, poor conformability, poor surface quality, no foreshortening, and good radiopacity. CONCLUSIONS There was considerable variation in the characteristics among the four evaluated SEMSs. These characteristics should be carefully considered during selection to ensure optimal therapeutic outcomes for patients. RELEVANCE STATEMENT The selection of self-expanding metal stents for treating malignant biliary obstruction requires careful consideration of various characteristics, including their radial force, crush resistance, axial force, conformability, surface quality, foreshortening, and radiopacity. KEY POINTS • The characteristics of self-expanding metal stents (SEMSs) can vary considerably. • Specific situations may warrant the use of SEMSs with particular characteristics over others. • Characteristics of SEMSs must be considered during selection for optimal outcomes.
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Affiliation(s)
- Jiaywei Tsauo
- Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
- Department of Interventional Radiology, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, 510080, China
| | - Yan Fu
- Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Yue Liu
- Department of Etiology and Carcinogenesis and State Key Laboratory of Molecular Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Xiaowu Zhang
- Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
| | - He Zhao
- Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China
| | - Xiao Li
- Department of Interventional Therapy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China.
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Miyazawa M, Takatori H, Okafuji H, Hayashi T, Toyama T, Yamada S, Kitamura K, Arai K, Sakai Y, Yamashita T, Yamashita T, Mizukoshi E, Honda M, Kaneko S. Efficacy of a novel self-expandable metal stent with dumbbell-shaped flare ends for distal biliary obstruction due to unresectable pancreatic cancer. Sci Rep 2022; 12:21100. [PMID: 36473910 PMCID: PMC9727129 DOI: 10.1038/s41598-022-25186-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/15/2022] [Accepted: 11/25/2022] [Indexed: 12/12/2022] Open
Abstract
This study aimed to evaluate the efficacy of a novel fully covered self-expandable metal stent (SEMS) with dumbbell-shaped flare ends for the palliation of distal biliary obstruction (DBO) due to unresectable pancreatic cancer (UPC). Patients with DBO due to UPC who received the novel HILZO fully covered stent (HFS), the WALLFLEX partially covered stent (WPS) or fully covered stent (WFS) were analyzed. The incidence of recurrent biliary obstruction (RBO), time to RBO (TRBO), and the incidence of complications were compared among the three SEMS groups. Eighty-four patients (HFS, n = 36; WPS, n = 20; WFS, n = 28) were included. The incidence of RBO was low in the HFS group (versus the WPS and WFS group, p = 0.033 and 0.023, respectively). TRBO in the HFS group was longer than that in the WFS group (p = 0.049). Placement of the HFS was an independent factor for long TRBO in multivariable analysis (p = 0.040). The incidence of pancreatitis and cholecystitis in the HFS group was low (one for each). It is recommended to use the HFS for the palliation of DBO due to UPC from the viewpoint of the low incidence of RBO and complications.
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Affiliation(s)
- Masaki Miyazawa
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Hajime Takatori
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Hirofumi Okafuji
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tomoyuki Hayashi
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tadashi Toyama
- grid.9707.90000 0001 2308 3329Innovative Clinical Research Center, Kanazawa University, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Shinya Yamada
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Kazuya Kitamura
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Kuniaki Arai
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Yoshio Sakai
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Taro Yamashita
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Tatsuya Yamashita
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Eishiro Mizukoshi
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Masao Honda
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
| | - Shuichi Kaneko
- grid.412002.50000 0004 0615 9100Department of Gastroenterology, Kanazawa University Hospital, 13-1, Takara-Machi, Kanazawa City, Ishikawa Prefecture 920-8641 Japan
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Gao DJ, Xing L, Ye X, Wang TT, Wu J, Xia MX, Hu B. Long Slimmer Metal Stent Is Feasible and Effective for Endoscopic Dual Stent-by-Stent Placement in Malignant Hilar Biliary Stricture. Dig Dis Sci 2022; 67:1073-1082. [PMID: 33675491 DOI: 10.1007/s10620-021-06906-6] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/21/2020] [Accepted: 02/19/2021] [Indexed: 12/27/2022]
Abstract
BACKGROUND Bilateral endoscopic biliary stenting remains technically challenging, which limits its wider clinical application. AIMS We have developed a novel long (10-12 cm) and slimmer (6 mm) self-expanded metal stent. The aim of this study was to evaluate the feasibility, efficacy, and safety of the new metal stent for palliative treatment of malignant hilar biliary strictures (MHBS). METHODS This retrospective study of prospectively collected data included 45 patients with unresectable malignant hilar biliary strictures of Bismuth type II or higher. A pair of long slimmer metal stents were sequentially placed into the intrahepatic duct using the stent-by-stent mode. The success rate and short- and long-term clinical outcomes were observed. RESULTS The technical success rate was 100%, with a mean procedure time of 43.7 ± 11.5 min. The clinical success was achieved in 44 patients (97.8%). Early adverse events included mild acute pancreatitis (n = 2) and cholangitis (n = 3). Later cholangitis occurred in 14 of the 45 patients due to stent occlusions. The median stent patency was 260 days (95% CI 228.3-291.7). Stent malfunctions occurred in 23 of the 45 patients, and 15 of them received bilateral endoscopic plastic stents placements. The technical success for the re-intervention was 100% with the mean procedure time of 24.3 ± 4.5 min. The median overall survival of the whole group was 229 days (95% CI 171.2-286.8). CONCLUSIONS The long slimmer metal stent for bilateral endoscopic stent-by-stent placement proved to be safe, feasible, and effective for MHBS and facilitates endoscopic re-intervention as well.
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Affiliation(s)
- Dao-Jian Gao
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Ling Xing
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Xin Ye
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Tian-Tian Wang
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Jun Wu
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Ming-Xing Xia
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China
| | - Bing Hu
- Department of Endoscopy, Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, 225 Changhai Road, Shanghai, 200438, People's Republic of China.
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Elshimi E, Morad W, Elshaarawy O, Attia A. Optimization of biliary drainage in inoperable distal malignant strictures. World J Gastrointest Endosc 2020; 12:285-296. [PMID: 32994859 PMCID: PMC7503617 DOI: 10.4253/wjge.v12.i9.285] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/09/2020] [Revised: 07/03/2020] [Accepted: 07/26/2020] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Given most patients with distal malignant biliary obstruction present in the non-resectable stage, palliative endoscopic biliary drainage with fully covered metal stent (FCMS) or uncovered metal stent (UCMS) is the only available measure to improve patients’ quality of life. Half covered metal stent (HCMS) has been recently introduced commercially. The adverse effects and stent function between FCMS and UCMS have been extensively discussed.
AIM To study the duration of stent patency of HCMS and compare it with FCMS and UCMS to optimize biliary drainage in inoperable patients with distal malignant obstruction. Secondary aims in our study included evaluation of patients’ survival and the rates of adverse events for each type of stent.
METHODS We studied 210 patients and randomized them into three equal groups; HCMS, FCMS and UCMS were inserted endoscopically.
RESULTS Stent occlusion occurred in (18.6%, 17.1% and 15.7% in HCMS, FCMS and UCMS groups, respectively, P = 0.9). Stent migration occurred only in patients with FCMS (8.6% of patients). Cholangitis and cholecystitis occurred in 11.4% and 5.7% of patients, respectively, in FCMS. Tumor growth occurred only in 10 cases among patients with UCMS after a median of 140 d, sludge occurred in nine, seven and one patients in HCMS, FCMS and UCMS, respectively (P = 0.04).
CONCLUSION Given the prolonged stent functioning time, the use of HCMS is preferred over the use of UCMS and FCMS for optimizing biliary drainage in patients with distal malignant biliary obstruction.
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Affiliation(s)
- Esam Elshimi
- Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebine Elkom 32111, Egypt
| | - Wesam Morad
- Department of Epidemiology and Preventive Medicine, National Liver Institute, Menoufia University, Shebine Elkom 32111, Egypt
| | - Omar Elshaarawy
- Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebine Elkom 32111, Egypt
| | - Ahmed Attia
- Department of Hepatology and Gastroenterology, National Liver Institute, Menoufia University, Shebine Elkom 32111, Egypt
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Shamah SP, Chapman CG, Haider H, Liao C, Waxman I, Siddiqui UD. Partially Covered Versus Uncovered Self-Expandable Metal Stents: Coating Nor Diameter Affect Clinical Outcomes. Dig Dis Sci 2019; 64:2631-2637. [PMID: 31041643 DOI: 10.1007/s10620-019-05643-1] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/11/2019] [Accepted: 04/23/2019] [Indexed: 12/18/2022]
Abstract
INTRODUCTION Jaundice is a common initial presentation of malignant biliary stricture. In patients with life expectancies that are greater than 3 months, self-expanding metal stents (SEMS) offer a larger diameter stent with longer patency and fewer complications compared to plastic stents. There have been conflicting results in the published literature as to efficacy and safety between the various SEMS types and diameters. We compared stent coating (PCSEMS vs USEMS) and diameter on clinical outcomes regarding management of malignant biliary obstruction. METHODS A retrospective cohort study was conducted using a database of consecutive patients who underwent an ERCP with biliary SEMS placement (only 8 and 10 mm) between 2009 and 2017. RESULTS In total, 278 patients who had SEMS at ERCP for malignant biliary obstruction were included (213 PCSEMS vs 65 USEMS). The groups were demographically evenly matched. Clinical success rates and patency duration were not statistically significant between PCSEMS and USEMS (98.1% vs 95.5%, P = 0.36, and 302.5 vs 225.5 days, P = 0.72, respectively). Adverse event rates were similar between both PCSEMS and USEMS with regard to overall adverse events. Stent diameter did not have an impact on overall clinical success (98.9% vs 95.3%, P = 0.11) or patency duration (239 days vs 336 days, P = 0.51). CONCLUSIONS Our comparison of PCSEMS versus USEMS and 8 mm versus 10 mm showed no difference in clinical efficacy or adverse events between the two SEMS coatings and diameter, illustrating that coating and size do not matter in regard to stent choice, despite prior suggestive data.
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Affiliation(s)
- S P Shamah
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA.
| | - C G Chapman
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA
| | - H Haider
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA
| | - C Liao
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA
| | - I Waxman
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA
| | - U D Siddiqui
- Center for Endoscopic Research and Therapeutics (CERT), University of Chicago Medicine, 5700 S. Maryland Avenue, MC 8043, Chicago, IL, 60637, USA
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Conio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc 2018; 88:283-291.e3. [PMID: 29653120 DOI: 10.1016/j.gie.2018.03.029] [Citation(s) in RCA: 67] [Impact Index Per Article: 9.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2017] [Accepted: 03/30/2018] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstructions. We aimed to compare stent patency, the adverse events rate, and overall survival of covered versus uncovered self-conformable metal stents in patients with primary malignant extrahepatic biliary strictures, not eligible for surgery. METHODS This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS), and 80 patients received uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) of 158 patients were analyzed. RESULTS Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; P = .031). Adverse events occurred with 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%); P = .061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly because of sludge or overgrowth; late stent occlusion because of tumor ingrowth occurred in 13.2% of patients in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (P = .23). CONCLUSION The number of stent-related adverse events was higher, although not significantly, among patients in the FCSEMS group. FCSEMSs had a significantly higher rate of migration than USEMSs, and stent occlusion occurred earlier. A significant difference in the patency rate was observed in favor of the USEMS group. (Clinical trial registration number: NCT02102984.).
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Affiliation(s)
- Massimo Conio
- Gastroenterology Department, General Hospital, Sanremo (IM)
| | | | - Angelo Caruso
- Gastroenterology and Digestive Endoscopy Department, Azienda Ospedaliera Universitaria di Modena, Sant'Agostino Estense Hospital, Baggiovara (MO)
| | | | - Todd H Baron
- Division of Gastroenterology and Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
| | - Luca De Luca
- Gastroenterology and Digestive Endoscopy Unit, Ospedali Riuniti Marche Nord, Pesaro
| | - Sergio Signorelli
- Gastroenterology and Gastrointestinal Endoscopy Unit, ASST, Papa Giovanni XXIII, Bergamo, Italy
| | - Mattia Crespi
- Gastroenterology Department, General Hospital, Sanremo (IM)
| | - Mario Marini
- Gastroenterology and Operative Endoscopy Unit, Santa Maria Alle Scotte Hospital, Siena, Italy
| | - Paolo Ravelli
- Gastroenterology and Gastrointestinal Endoscopy Unit, ASST, Papa Giovanni XXIII, Bergamo, Italy
| | - Rita Conigliaro
- Gastroenterology and Digestive Endoscopy Department, Azienda Ospedaliera Universitaria di Modena, Sant'Agostino Estense Hospital, Baggiovara (MO)
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Flores Carmona DY, Alonso Lárraga JO, Hernández Guerrero A, Ramírez Solís ME. Comparison of covered and uncovered self-expandable stents in the treatment of malignant biliary obstruction. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2017; 108:246-9. [PMID: 26999335 DOI: 10.17235/reed.2016.4161/2015] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
BACKGROUND AND OBJECTIVE Drainage with metallic stents is the treatment of choice in malignant obstructive jaundice. Technical and clinical success with metallic stents is obtained in over 90% and 80% of cases, respectively. There are self-expandable metallic stents designed to increase permeability. The aim of this study was to describe the results obtained with totally covered self-expandable and uncovered self-expandable metallic stents in the palliative treatment of malignant biliary obstruction. PATIENTS AND METHODS Sixty eight patients with malignant obstructive jaundice secondary to pancreatobiliary or metastatic disease not amenable to surgery were retrospectively included. Two groups were created: group A (covered self-expandable metallic stents) (n = 22) and group B (uncovered self-expandable metallic stents) (n = 46). RESULTS Serum total bilirubin, direct bilirubin, alkaline phosphatase and gamma glutamyl transferase levels decreased in both groups and no statistically significant difference was detected (p = 0.800, p = 0.190, p = 0.743, p = 0.521). Migration was greater with covered stents but it was not statistically significant either (p = 0.101). Obstruction was greater in the group with uncovered stents but it was not statistically significant either (p = 0.476). CONCLUSION There are no differences when using covered self-expandable stents or uncovered self-expandable stents in terms of technical and clinical success or complications in the palliative treatment of malignant obstructive jaundice.
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Covered Stents versus Uncovered Stents for Unresectable Malignant Biliary Strictures: A Meta-Analysis. BIOMED RESEARCH INTERNATIONAL 2016; 2016:6408067. [PMID: 27051667 PMCID: PMC4802019 DOI: 10.1155/2016/6408067] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/15/2015] [Revised: 01/29/2016] [Accepted: 02/17/2016] [Indexed: 12/17/2022]
Abstract
Aim. To summarize the covered or uncovered SEMS for treatment of unresectable malignant distal biliary obstruction, comparing the stent patency, patient survival, and incidence of adverse events between the two SEMSs. Methods. The meta-analysis search was performed independently by two of the authors, using MEDLINE, EMBASE, OVID, and Cochrane databases on all studies between 2010 and 2015. Pooled effect was calculated using either the fixed or the random effects model. Results. Statistics shows that there is no difference between SEMSs in the hazard ratio for patient survival (HR 1.04; 95% CI, 0.92–1.17; P = 0.55) and stent patency (HR 0.87, 95% CI: 0.58 to 1.30, P = 0.5). However, incidence of adverse events (OR: 0.74, 95% CI: 0.57 to 0.97, P = 0.03) showed significant different results in the covered SEMS, with dysfunctions events (OR: 0.75, 95% CI: 0.56 to 1.00, P = 0.05) playing a more important role than complications (OR: 0.87, 95% CI: 0.58 to 1.30, P = 0.50). Conclusions. Covered SEMS group had lower incidence of adverse events. There is no significant difference in dysfunctions, but covered SEMS trends to be better, with no difference in stent patency, patient survival, and complications.
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Shatzel J, Kim J, Sampath K, Syed S, Saad J, Hussain ZH, Mody K, Pipas JM, Gordon S, Gardner T, Rothstein RI. Drug eluting biliary stents to decrease stent failure rates: A review of the literature. World J Gastrointest Endosc 2016; 8:77-85. [PMID: 26839648 PMCID: PMC4724033 DOI: 10.4253/wjge.v8.i2.77] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/03/2015] [Revised: 08/11/2015] [Accepted: 10/28/2015] [Indexed: 02/05/2023] Open
Abstract
Biliary stenting is clinically effective in relieving both malignant and non-malignant obstructions. However, there are high failure rates associated with tumor ingrowth and epithelial overgrowth as well as internally from biofilm development and subsequent clogging. Within the last decade, the use of prophylactic drug eluting stents as a means to reduce stent failure has been investigated. In this review we provide an overview of the current research on drug eluting biliary stents. While there is limited human trial data regarding the clinical benefit of drug eluting biliary stents in preventing stent obstruction, recent research suggests promise regarding their safety and potential efficacy.
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Percutaneous transhepatic cholangiography and intraductal radiofrequency ablation combined with biliary stent placement for malignant biliary obstruction. J Vasc Interv Radiol 2015; 26:715-21. [PMID: 25817458 DOI: 10.1016/j.jvir.2015.01.037] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/17/2014] [Revised: 01/30/2015] [Accepted: 01/30/2015] [Indexed: 12/25/2022] Open
Abstract
PURPOSE To determine the safety and feasibility of percutaneous transhepatic cholangiography (PTC) and intraductal radiofrequency (RF) ablation combined with biliary stent placement for malignant biliary obstruction. MATERIALS AND METHODS Data from patients with unresectable malignant biliary obstruction who underwent PTC, intraductal RF ablation, and biliary stent placement (n = 12) or PTC and biliary stent placement only (control group; n = 14) were reviewed. Postoperative complications, jaundice remission, and stent patency were assessed. RESULTS All procedures were successful. No severe complications (eg, biliary bleeding, perforation) occurred. Two experimental group patients developed cholangitis, which resolved with conservative treatment. The 1-week jaundice remission and 3-month stent patency rates were similar in both groups, but the 6-month stent patency rate was higher in the experimental group (P < .05). In the experimental group, one death occurred as a result of gastrointestinal hemorrhage (unrelated to stent placement) by 3 months, and there were two cases of recurrent jaundice by 6 months. The latter two patients underwent repeat PTC, ablation, and stent placement. In the control group, one death occurred as a result of hepatic failure caused by progressive jaundice at 3 months, and another death resulted from disseminated intravascular coagulation caused by jaundice recurrence at 138 days after stent placement. In addition, seven patients developed jaundice recurrence (50-151 d after stent placement). PTC and repeat stent placement were performed in these patients. CONCLUSIONS Percutaneous transhepatic cholangiography and intraductal RF ablation combined with biliary stent placement for malignant biliary obstruction is safe and feasible and effectively prolongs stent patency time.
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Sigurdardottir KR, Oldervoll L, Hjermstad MJ, Kaasa S, Knudsen AK, Løhre ET, Loge JH, Haugen DF. How are palliative care cancer populations characterized in randomized controlled trials? A literature review. J Pain Symptom Manage 2014; 47:906-914.e17. [PMID: 24018205 DOI: 10.1016/j.jpainsymman.2013.06.005] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/26/2013] [Revised: 06/05/2013] [Accepted: 06/14/2013] [Indexed: 02/08/2023]
Abstract
CONTEXT The difficulties in defining a palliative care patient accentuate the need to provide stringent descriptions of the patient population in palliative care research. OBJECTIVES To conduct a systematic literature review with the aim of identifying which key variables have been used to describe adult palliative care cancer populations in randomized controlled trials (RCTs). METHODS The data sources used were MEDLINE (1950 to January 25, 2010) and Embase (1980 to January 25, 2010), limited to RCTs in adult cancer patients with incurable disease. Forty-three variables were systematically extracted from the eligible articles. RESULTS The review includes 336 articles reporting RCTs in palliative care cancer patients. Age (98%), gender (90%), cancer diagnosis (89%), performance status (45%), and survival (45%) were the most frequently reported variables. A large number of other variables were much less frequently reported. CONCLUSION A substantial variation exists in how palliative care cancer populations are described in RCTs. Few variables are consistently registered and reported. There is a clear need to standardize the reporting. The results from this work will serve as the basis for an international Delphi process with the aim of reaching consensus on a minimum set of descriptors to characterize a palliative care cancer population.
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Affiliation(s)
- Katrin Ruth Sigurdardottir
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Sunniva Centre for Palliative Care, Haraldsplass Deaconess Hospital, Bergen, Norway; Regional Centre of Excellence for Palliative Care, Western Norway, Haukeland University Hospital, Bergen, Norway.
| | - Line Oldervoll
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Røros Rehabilitation Centre, Røros, Norway
| | - Marianne Jensen Hjermstad
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Regional Centre for Excellence in Palliative Care, South Eastern Norway, Oslo University Hospital, Oslo, Norway
| | - Stein Kaasa
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
| | - Anne Kari Knudsen
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
| | - Erik Torbjørn Løhre
- Department of Oncology, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway
| | - Jon Håvard Loge
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; National Resource Centre for Late Effects After Cancer Treatment, Oslo University Hospital, Oslo, Norway
| | - Dagny Faksvåg Haugen
- European Palliative Care Research Centre, Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway; Regional Centre of Excellence for Palliative Care, Western Norway, Haukeland University Hospital, Bergen, Norway
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Shimizu S, Naitoh I, Nakazawa T, Hayashi K, Miyabe K, Kondo H, Yoshida M, Yamashita H, Umemura S, Hori Y, Ohara H, Joh T. Predictive factors for pancreatitis and cholecystitis in endoscopic covered metal stenting for distal malignant biliary obstruction. J Gastroenterol Hepatol 2013; 28:68-72. [PMID: 23020651 DOI: 10.1111/j.1440-1746.2012.07283.x] [Citation(s) in RCA: 57] [Impact Index Per Article: 4.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/14/2012] [Indexed: 12/18/2022]
Abstract
BACKGROUND AND AIM Pancreatitis and cholecystitis are major complications after self-expandable metal stent (SEMS) placement in distal malignant biliary obstruction. We aimed to clarify predictive factors for pancreatitis and cholecystitis after covered SEMS placement. METHODS We retrospectively reviewed 74 consecutive patients with distal malignant biliary obstruction who underwent initial endoscopic drainage using covered SEMS. Predictive factors for pancreatitis and cholecystitis were evaluated in the 74 patients described above and in 66 patients who had not undergone cholecystectomy. RESULTS The incidences of pancreatitis and cholecystitis were 10.8% (8/74) and 6.1% (4/66), respectively. Univariate analysis revealed that non-pancreatic cancer (P = 0.018) and contrast injection into the pancreatic duct (P = 0.030) were significant predictive factors for pancreatitis. Multivariate analysis revealed that non-pancreatic cancer (odds ratio [OR], 4.21; 95% confidence interval [CI], 1.63-14.18; P = 0.007) and contrast injection into the pancreatic duct (OR, 3.34; 95% CI, 1.33-9.60; P = 0.016) were significant independent predictive factors for pancreatitis. On the other hand, univariate and multivariate analyses revealed that tumor involvement to the orifice of the cystic duct (OCD) was a significant independent predictive factor for cholecystitis (OR, 5.85; 95% CI, 1.91-27.74; P = 0.005). CONCLUSIONS Non-pancreatic cancer and contrast injection into the pancreatic duct were predictive factors for pancreatitis, and tumor involvement to the OCD was a positive predictive factor for cholecystitis after endoscopic covered SEMS placement for distal malignant biliary obstruction.
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Affiliation(s)
- Shuya Shimizu
- Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
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Jaganmohan S, Lee JH. Self-expandable metal stents in malignant biliary obstruction. Expert Rev Gastroenterol Hepatol 2012; 6:105-14. [PMID: 22149586 DOI: 10.1586/egh.11.95] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Malignant biliary obstruction can be due to direct tumor infiltration, extrinsic compression, adjacent inflammation, desmoplastic reaction from tumors or, more commonly, a combination of the above factors. Pancreatic cancer is the most common cause of malignant biliary obstruction, and jaundice occurs in 70-90% of the patients during the course of the disease. Compared with the uncovered metal stents, covered metal stents have longer patency and a lower rate of tumor ingrowth, but have a higher rate of stent migration. To combat the occlusion and provide an antitumor effect, drug-eluting stents were developed. A duodenal stricture complicates biliary stent placement in 10-20% of patients with distal biliary obstruction due to pancreatic cancer. When both strictures are considered, a biliary stent can be placed either preceding or following duodenal stent placement. Complications of self-expandable metal stents include stent occlusion, stent migration, cholecystitis and pancreatitis.
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Affiliation(s)
- Sathya Jaganmohan
- Department of Gastroenterology, Hepatology, and Nutrition, MD Anderson Cancer Center, University of Texas, Houston, TX, USA
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Akamatsu N, Sugawara Y, Shin N, Komagome M, Ishida T, Ozawa F, Odaka A, Hashimoto D. One-step percutaneous transhepatic insertion of a balloon-expanding metallic stent for obstructive jaundice. J Gastroenterol Hepatol 2011; 26:1795-1803. [PMID: 21649728 DOI: 10.1111/j.1440-1746.2011.06803.x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND AND AIM The aim of this study was to evaluate the efficacy and safety of one-step percutaneous transhepatic insertion of the Express LD stent, a balloon-expanding stainless steel stent used for the management of distal artery stenosis in the treatment of obstructive jaundice caused by various inoperable malignancies. METHODS Seventy-one consecutive patients with unresectable malignant biliary obstruction who underwent Express LD stent placement between 2007 and 2010 at our institute were reviewed. RESULTS Mean stent patency was 165 ± 144 days and mean patient survival was 180 ± 156 days, while the cumulative stent patency rate and patient survival rate at 6 and 12 months were 79% and 65%, and 38% and 16%, respectively. Stents were successfully placed in all cases without any stent migration or misplacement. Stent failure occurred in 14 patients (20%), and 16 complications were observed, including 12 cholangitis (17%), two cholecysitis (3%), and two pancreatitis (3%). Y-configuration stenting for hilar bile duct obstruction was the only independent prognostic factor for stent failure. CONCLUSIONS One-step percutaneous transhepatic insertion of the Express LD stent is effective and safe for the management of obstructive jaundice caused by inoperable malignancies.
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Affiliation(s)
- Nobuhisa Akamatsu
- Department of Hepato-biliary-pancreatic Surgery, Saitama Medical Center, Saitama Medical University, Saitama, Japan
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Saleem A, Leggett CL, Murad MH, Baron TH. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 2011; 74:321-327.e1-3. [PMID: 21683354 DOI: 10.1016/j.gie.2011.03.1249] [Citation(s) in RCA: 190] [Impact Index Per Article: 13.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/18/2011] [Accepted: 03/28/2011] [Indexed: 02/06/2023]
Abstract
BACKGROUND Self-expandable metal stents (SEMSs) are used for palliation of malignant biliary obstruction. OBJECTIVE We performed a meta-analysis to compare stent patency and stent survival of covered SEMSs (CSEMSs) and uncovered SEMSs (USEMSs) in patients with unresectable distal malignant biliary obstruction. DESIGN Meta-analysis. SETTING Tertiary-care facility. PATIENTS A comprehensive search of several databases (from each database's earliest inclusive dates to November 2010, any language, and any population) was conducted. The search identified 337 potential abstracts and titles, of which 16 were retrieved in full text. Review of references identified 17 additional studies. We found 5 multicenter, randomized trials involving 781 patients. INTERVENTION Placement of covered and uncovered SEMSs for treatment of distal malignant biliary obstruction. MAIN OUTCOME MEASUREMENTS Stent patency, stent survival, patient survival, and cause for stent dysfunction (ingrowth, overgrowth, migration, and sludge formation). RESULTS The median length of follow-up was 212 days. Compared with USEMSs, CSEMSs were associated with significantly prolonged stent patency (weighted mean difference [WMD] 60.56 days; 95% confidence interval [CI], 25.96, 95.17; I² = 0%) and longer stent survival (WMD 68.87 days; 95% CI, 25.64, 112.11; I(2) = 79%). Stent migration, tumor overgrowth, and sludge formation were significantly higher with CSEMSs (relative risk [RR] 8.11; 95% CI, 1.47, 44.76; I² = 0%), (RR 2.02; 95% CI, 1.08, 3.78; I² = 0%), (RR 2.89; 95% CI, 1.27, 6.55; I² = 0%). LIMITATIONS Relatively low number of studies available and the fact that 2 of the 5 studies were from one institution. Also, the limited availability of some stents used in the trials may limit the applicability of these results. CONCLUSION CSEMSs have a significantly longer duration of patency compared with USEMSs in patients with distal malignant biliary obstruction. Stent dysfunction occurs at a similar rate, although there is a trend toward later obstruction with CSEMSs.
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Affiliation(s)
- Atif Saleem
- Department of Internal Medicine, Mayo Clinic, College of Medicine, Rochester, Minnesota, USA
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Ferreira LEVVDC, Baron TH. Endoscopic stenting for palliation of malignant biliary obstruction. Expert Rev Med Devices 2011; 7:681-91. [PMID: 20822390 DOI: 10.1586/erd.10.36] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Malignant biliary obstruction results in jaundice, often with symptoms that decrease the quality of life. Biliary stent placement has largely supplanted surgical bypass for palliation of malignant biliary obstruction. Traditional rigid plastic stents are commonly used, inexpensive and easily removed, although with limited duration of stent patency. Self-expandable metal stents (SEMS) attain larger luminal diameters and provide longer patency than traditional rigid plastic stents in patients with distal bile duct obstruction. SEMS are composed of a variety of metals and can be uncoated, partially covered, or fully covered. Data do not support a prolongation of patency with covered SEMS for distal obstruction, although they have the potential for removability. The data to support SEMS for palliation of hilar biliary obstruction are not as convincing and reintervention for stent occlusion can be difficult. In this article, the design and performance of expandable metal stents for treatment of malignant biliary obstruction will be reviewed.
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Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc 2011; 73:149-53. [PMID: 21184881 DOI: 10.1016/j.gie.2010.09.031] [Citation(s) in RCA: 222] [Impact Index Per Article: 15.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/16/2010] [Accepted: 09/15/2010] [Indexed: 02/08/2023]
Abstract
BACKGROUND In unresectable malignant bile duct obstruction in a patient with a life expectancy longer than 3 months, the use of self-expandable metal stents (SEMSs) is the standard technique to ensure continued biliary drainage. As many as 50% of patients with SEMSs will present with stent occlusion within 6 months. Changes to stent design and composition and concomitant therapy have failed to improve stent patency; therefore, alternative techniques to safely prolong stent patency are required. OBJECTIVE To demonstrate the safety of endobiliary bipolar radiofrequency ablation (RFA) in patients with malignant biliary obstruction and to report the 90-day biliary patency of this novel procedure. DESIGN Open-label pilot study. SETTING Single tertiary care unit. PATIENTS A total of 22 patients with unresectable malignant bile duct obstruction. INTERVENTIONS Bipolar RFA within the bile duct. MAIN OUTCOME MEASUREMENTS Immediate and 30-day complications and 90-day stent patency. RESULTS A total of 22 patients (16 pancreatic, 6 cholangiocarcinoma) were recruited between January 2009 and April 2010. Deployment of an RFA catheter was successful in 21 patients. SEMS placement was achieved in all cases of successful RFA catheter deployment. One patient failed to demonstrate successful biliary decompression after SEMS placement and died within 90 days. All other patients maintained stent patency at 30 days. One patient had asymptomatic biochemical pancreatitis, 2 patients required percutaneous gallbladder drainage, and 1 patient developed rigors. At 90-day follow-up, 1 additional patient had died with a patent stent, and 3 patients had occluded biliary stents. LIMITATIONS Cohort study. CONCLUSIONS Endobiliary RFA treatment appears to be safe. Randomized studies with prolonged follow-up are warranted.
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Kullman E, Frozanpor F, Söderlund C, Linder S, Sandström P, Lindhoff-Larsson A, Toth E, Lindell G, Jonas E, Freedman J, Ljungman M, Rudberg C, Ohlin B, Zacharias R, Leijonmarck CE, Teder K, Ringman A, Persson G, Gözen M, Eriksson O. Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study. Gastrointest Endosc 2010; 72:915-923. [PMID: 21034892 DOI: 10.1016/j.gie.2010.07.036] [Citation(s) in RCA: 220] [Impact Index Per Article: 14.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2010] [Accepted: 07/24/2010] [Indexed: 02/07/2023]
Abstract
BACKGROUND Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. OBJECTIVE To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. DESIGN Randomized, multicenter trial conducted between January 2006 and October 2008. SETTING Ten sites serving a total catchment area of approximately 2.8 million inhabitants. PATIENTS A total of 400 patients with unresectable distal malignant biliary obstruction. INTERVENTIONS ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. MAIN OUTCOME MEASUREMENTS Time to stent failure, survival time, and complication rate. RESULTS The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). LIMITATIONS Randomization was not blinded. CONCLUSIONS There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents.
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Ross WA, Egwim CI, Wallace MJ, Wang M, Madoff DC, Lee JH. Outcomes in lymphoma patients with obstructive jaundice: a cancer center experience. Dig Dis Sci 2010; 55:3271-7. [PMID: 20632106 DOI: 10.1007/s10620-010-1310-6] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/15/2010] [Accepted: 06/14/2010] [Indexed: 12/13/2022]
Abstract
BACKGROUND Little information is available to guide clinicians on the optimal approach to managing obstructive jaundice in lymphoma patients. AIMS The aim of this study was to review our experience in treating lymphoma patients with obstructive jaundice in order to develop guidelines as to the best interventional approach. METHODS We reviewed the medical records of all lymphoma patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) and/or percutaneous biliary drainage (PBD) for obstructive jaundice between June 2002 and October 2008. RESULTS We identified 35 lymphoma patients who underwent ERCP and/or PBD for obstructive jaundice. The mean age was 57.6 years. Most patients (66%) had diffuse large B-cell lymphoma. Stents were placed by ERCP in 25 patients and PBD in nine. Serum bilirubin levels normalized following ERCP or PBD in 29 of 33 (85%) patients with stricture. Stricture resolution occurred in 12 cases. Patients who had obstructive jaundice at the time of their lymphoma diagnosis had significantly longer mean overall survival following intervention than patients in whom obstructive jaundice developed later in the course of their disease (21.3 months vs. 4.5 months, P = 0.0001). CONCLUSIONS ERCP and/or PBD effectively normalized serum bilirubin levels. Plastic stents should be used in patients who have obstructive jaundice at the time of lymphoma diagnosis because these strictures tend to resolve before stent exchanges are necessary. For patients in whom obstructive jaundice develops later in the course of their disease, the limited prognosis often makes a single intervention with insertion of a plastic stent sufficient to provide adequate biliary decompression.
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Affiliation(s)
- William A Ross
- Department of Gastroenterology, Hepatology and Nutrition, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
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Coté GA, Kumar N, Ansstas M, Edmundowicz SA, Jonnalagadda S, Mullady DK, Azar RR. Risk of post-ERCP pancreatitis with placement of self-expandable metallic stents. Gastrointest Endosc 2010; 72:748-54. [PMID: 20630513 DOI: 10.1016/j.gie.2010.05.023] [Citation(s) in RCA: 103] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/02/2010] [Accepted: 05/11/2010] [Indexed: 12/11/2022]
Abstract
BACKGROUND There are conflicting data on the risk of post-ERCP pancreatitis (PEP) related to self-expandable metallic stents (SEMSs). OBJECTIVE To compare rates of PEP in patients who undergo biliary drainage with SEMSs or polyethylene stents (PSs). DESIGN Retrospective, cohort study. SETTING Tertiary-care medical center. PATIENTS This study involved patients undergoing ERCP for malignant biliary obstruction between January 2005 and October 2008. INTERVENTION First-time placement of a SEMS or PS for biliary decompression. MAIN OUTCOME MEASUREMENTS Early post-ERCP complications, particularly PEP. RESULTS We identified 544 eligible patients, 248 SEMSs (102 covered), and 296 PSs. The etiology of malignant biliary obstruction was similar between groups, with 55% from pancreatic cancer. The frequency of PEP was significantly higher in the SEMS group (7.3%) versus the PS group (1.3%) (OR 5.7 [95% CI, 1.9-17.1]). On univariate analysis, patient age of <40 years, a history of PEP, and at least 1 pancreatic duct injection were also significant predictors of PEP, whereas female sex and having pancreatic cancer were not. When significant variables were added to a multiple-predictor regression model, the odds of PEP from SEMS placement increased to 6.8 (95% CI, 2.2, 21.4). However, the frequency of PEP was similar between covered (6.9%) and uncovered (7.5%) SEMSs (OR 0.9 [CI, 0.3-2.4]). Purported SEMS-specific risk factors, including the use of cSEMSs, overlapping SEMSs, or having a biliary sphincterotomy were not found to be significant contributors to the higher risk. LIMITATIONS Retrospective design. CONCLUSION After we controlled for confounding variables, the frequency of PEP was significantly higher with placement of a SEMS compared with a PS. Rates of PEP were comparable with use of covered and uncovered SEMSs.
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Affiliation(s)
- Gregory A Coté
- Division of Gastroenterology, Washington University, St Louis School of Medicine, St Louis, Missouri, USA.
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Considering an investment in precious metals? Time to take stock. Gastrointest Endosc 2010; 72:755-7. [PMID: 20883852 DOI: 10.1016/j.gie.2010.06.050] [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: 06/17/2010] [Accepted: 06/28/2010] [Indexed: 02/08/2023]
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Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc 2009; 70:445-53. [PMID: 19482279 DOI: 10.1016/j.gie.2008.11.018] [Citation(s) in RCA: 109] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/30/2008] [Accepted: 11/05/2008] [Indexed: 12/17/2022]
Abstract
BACKGROUND The Wallstent has remained the industry standard for biliary self-expanding metal stents (SEMSs). Recently, stents of differing designs, compositions, and diameters have been developed. OBJECTIVE To compare the new nitinol 6-mm and 10-mm Zilver stents with the 10-mm stainless steel Wallstent and determine the mechanism of obstruction. DESIGN Randomized, prospective, controlled study. SETTING Nine centers experienced in SEMS placement during ERCP. PATIENTS A total of 241 patients presenting between September 2003 and December 2005 with unresectable malignant biliary strictures at least 2 cm distal to the bifurcation. MAIN OUTCOME MEASUREMENT Stent occlusions requiring reintervention and death. RESULTS At interim analysis, a significant increase in occlusions was noted in the 6-mm Zilver group at the P = .04 level, resulting in arm closure but continued follow-up. Final study arms were 64, 88, and 89 patients receiving a 6-mm Zilver, 10-mm Zilver, and 10-mm Wallstent, respectively. Stent occlusions occurred in 25 (39.1%) of the patients in the 6-mm Zilver arm, 21 (23.9%) of the patients in the 10-mm Zilver arm, and 19 (21.4%) of the patients in the 10-mm Wallstent arm (P = .02). The mean number of days of stent patency were 142.9, 185.8, and 186.7, respectively (P = .057). No differences were noted in secondary endpoints, and the study was ended at the 95% censored study endpoints. Biopsy specimens of ingrowth occlusive tissue revealed that 56% were caused by benign epithelial hyperplasia. CONCLUSIONS SEMS occlusions were much more frequent with a 6-mm diameter SEMS and equivalent in the two 10-mm arms despite major differences in stent design, material, and expansion, suggesting that diameter is the critical feature. Malignant tumor ingrowth produced only a minority of the documented occlusions.
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The evolution and the natural selection process in the stenting of malignant bile duct obstruction: size does matter! Gastrointest Endosc 2009; 70:454-6. [PMID: 19699977 DOI: 10.1016/j.gie.2009.03.026] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2009] [Accepted: 03/12/2009] [Indexed: 02/08/2023]
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A comparison of the Niti-D biliary uncovered stent and the uncovered Wallstent in malignant biliary obstruction. Gastrointest Endosc 2009; 70:45-51. [PMID: 19559832 DOI: 10.1016/j.gie.2008.10.029] [Citation(s) in RCA: 40] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2008] [Accepted: 10/13/2008] [Indexed: 12/18/2022]
Abstract
BACKGROUND The conformability of uncovered self-expandable metal stents (SEMSs) plays an important role in maintaining stent patency. However, whether increased conformability can prolong the duration of SEMS patency remains to be proved. OBJECTIVE The aim of this study was to examine the efficacy and complication rates of the Niti-D biliary uncovered metal stent (NDS), which is more conformable than the uncovered Wallstent. DESIGN Nonrandomized, retrospective study. SETTING Tertiary-care academic medical center. PATIENTS From March 2005 to July 2007, 101 patients received an NDS (41 cases) or a Wallstent (60 cases) for malignant biliary obstruction. INTERVENTIONS SEMS placement. RESULTS Stent occlusion occurred in 11 patients (26.8%) with the NDS and 17 patients (28.3%) with the Wallstent. The median duration of stent patency tended to be longer for the NDS group (153 days) than for the Wallstent group (124 days); however, the difference was not statistically significant (P = .204). The median duration of overall survival of patients was 160 days for the NDS and 148 days for the Wallstent. The subgroup analysis showed that 27 patients had hilar obstruction (NDS 13, Wallstent 14). The median duration of stent patency was 249 days for the NDS group and 76 days for the Wallstent group; this difference was statistically significant (P = .006). The complications included pancreatitis in 3 NDS cases and 5 Wallstent cases. LIMITATION The absence of prospective randomized recruitment. CONCLUSION The results of this study showed no significant differences between the NDS and the Wallstent for the palliative endoscopic management of malignant biliary obstruction. There were no significant differences in patency, complication rates, and patient survival between the more conformable NDS and the conventional Wallstent. However, the NDS, which has good conformability, may be preferred for hilar obstruction.
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Abstract
BACKGROUND Endoscopic stent insertion is the optimum method of palliation for malignant biliary obstruction. Various types of self-expanding metal stents have been introduced in the market. Whether one type of stents is superior to the others in terms of stent patency remains undefined. GOALS This randomized trial compared 2 uncovered metal stents with similar technical characteristics, but significant cost difference, in the palliation of inoperable malignant biliary strictures. STUDY Ninety-two patients with inoperable biliary obstruction were randomized to receive either a 10-mm diameter Hanaro or Luminex uncovered metal stent. The duration of stent patency, the overall patient survival, the mechanism of stent occlusion, and the adverse events were analyzed. RESULTS Eighty-nine patients were included in the analysis; 44 received Hanaro stents and 45 Luminex stents. The overall median patency rates between the 2 stents did not differ (328 d for the Hanaro vs. 289 d for the Luminex stent; P=0.815). Similarly, no difference was found between the overall median survival rates by the 2 stents (347 d for the Hanaro vs. 307 d for the Luminex stent; P=0.654). Two major procedure-related complications occurred, perforation (Hanaro stent) and proximal stent migration (Luminex stent). Stent occlusion requiring reintervention occurred in 25 patients (11 with the Hanaro vs. 14 with the Luminex stent; P=0.521). CONCLUSIONS The 2 uncovered metal stents are comparable in terms of placement, occlusion rates, overall stent patency, and patient survival; Hanaro stent insertion, however, seems to be a cost-saving strategy at least in Greece.
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Sanders M, Papachristou GI, McGrath KM, Slivka A. Endoscopic palliation of pancreatic cancer. Gastroenterol Clin North Am 2007; 36:455-76, xi. [PMID: 17533090 DOI: 10.1016/j.gtc.2007.04.001] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Endoscopic approaches have revolutionized the palliation of advanced pancreatic cancer. The ideal management consists of a multidisciplinary approach involving surgeons, endoscopists, radiologists, and oncologists. Concurrent advances in the fields of interventional radiology and laparoscopic surgical oncology should be readdressed and directly compared with endoscopic approaches in randomized controlled trials. Exciting novel endoscopic techniques are being developed and evaluated; however, these approaches require further validation with randomized clinical trials to determine the safety and efficacy when compared with more traditional approaches.
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Affiliation(s)
- Michael Sanders
- Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh Medical Center, Mezzanine Level, C-Wing, UPMC Presbyterian, 200 Lothrop Street, Pittsburgh, PA 15213, USA.
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Cipolletta L, Rotondano G, Marmo R, Bianco MA. Endoscopic palliation of malignant obstructive jaundice: an evidence-based review. Dig Liver Dis 2007; 39:375-88. [PMID: 17317347 DOI: 10.1016/j.dld.2006.12.016] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2006] [Revised: 11/14/2006] [Accepted: 12/14/2006] [Indexed: 12/11/2022]
Abstract
Endoscopic stent insertion is considered the method of choice for palliative treatment of malignant biliary obstruction. Nonetheless, relevant studies are often underpowered or outdated and do not compare actual surgical outcomes with latest stent technology. Purpose of this review was to assess, with an evidence-based methodology, the role of endoscopic versus surgical palliation of patients with malignant obstructive jaundice with special reference to clinical effectiveness, safety aspects and economic outcomes.
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Affiliation(s)
- L Cipolletta
- Department of Gastroenterology and Digestive Endoscopy, Hospital Maresca, Torre del Greco, Naples, Italy
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Malignant distal biliary obstruction: a systematic review and meta-analysis of endoscopic and surgical bypass results. Cancer Treat Rev 2006; 33:213-21. [PMID: 17157990 DOI: 10.1016/j.ctrv.2006.10.006] [Citation(s) in RCA: 128] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2006] [Revised: 10/24/2006] [Accepted: 10/24/2006] [Indexed: 12/17/2022]
Abstract
BACKGROUND Surgical bypass and endoscopic stents are available for palliative bypass of malignant distal biliary obstruction. AIM Comparison of reported outcomes in randomized controlled trials (RCTs) which included surgery, endoscopic plastic stents or endoscopic metal stents in palliative relief of malignant distal biliary obstruction. METHODS Systematic review and meta-analysis of published literature and conference proceedings review to June 2006. RESULTS We found 24 studies, containing 2436 patients, which met our inclusion criteria. Endoscopic stenting with plastic stents (three studies) is associated with a lower risk of complications (RR 0.60, 95% CI 0.45-0.81), but a higher risk of recurrent biliary obstruction (RR 18.59, 95% CI 5.33 -64.86) than traditional surgical bypass. Self-expanding metal stents (seven studies) are associated with a significantly reduced risk of recurrent biliary obstruction at 4 months (RR 0.44, 95% CI 0.3, 0.63), or prior to death or end of study (RR 0.52, 95% CI 0.39-0.69), but are not superior to plastic stents in terms of technical success, therapeutic success, mortality or complications. Cost-effectiveness outcomes were not suitable for meta-analysis. No other plastic stent designs have been demonstrated to be superior to polyethylene stents (12 studies). CONCLUSIONS Endoscopic metal stents are the intervention of choice in patients with malignant distal biliary obstruction, producing similar outcomes to plastic stents, but with improved patency rates.
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Katsinelos P, Paikos D, Kountouras J, Chatzimavroudis G, Paroutoglou G, Moschos I, Gatopoulou A, Beltsis A, Zavos C, Papaziogas B. Tannenbaum and metal stents in the palliative treatment of malignant distal bile duct obstruction: a comparative study of patency and cost effectiveness. Surg Endosc 2006; 20:1587-93. [PMID: 16897286 DOI: 10.1007/s00464-005-0778-1] [Citation(s) in RCA: 64] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/16/2005] [Accepted: 04/02/2006] [Indexed: 02/08/2023]
Abstract
BACKGROUND Stent clogging is the major limitation of palliative treatment for malignant biliary obstruction. Metal stents have much better patency than plastic stents, but are more expensive. Preliminary data suggest that the recently designed plastic (Tannenbaum) stent has better duration of patency than the polyethylene stent. This study aimed to compare the efficacy and cost effectiveness between the Tannenbaum stent without side holes and the uncovered metal stent for patients with malignant distal common bile duct obstruction. METHODS In this study, 47 patients (median age, 73 years, range, 56-86 years) with inoperable malignant distal common bile duct strictures were prospectively randomized to receive either a Tannenbaum stent (n = 24) or an uncovered self-expandable metal stent (n = 23). The patients were clinically evaluated, and biochemical tests were analyzed if necessary until their death or surgery for gastric outlet obstruction. Cumulative first stent patency and patient survival were compared between the two groups. Cost-effectiveness analysis also was performed for the two study groups. RESULTS The two groups were comparable in terms of age, gender, and diagnosis. The median first stent patency was longer in the metal group than in the Tannenbaum stent group (255 vs 123.5 days; p = 0.002). There was no significant difference in survival between the two groups. The total cost associated with the Tannenbaum stents was lower than for the metal stents (17,700 vs 30,100 euros; p = 0.001), especially for patients with liver metastases (3,000 vs 6,900 euros; p < 0.001). CONCLUSIONS Metal stent placement is an effective treatment for inoperable malignant distal common bile duct obstruction, but Tannenbaum stent placement is a cost-saving strategy, as compared with metal stent placement, especially for patients with liver metastases and expected short survival time.
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Affiliation(s)
- P Katsinelos
- Department of Endoscopy and Motility Unit, Central Hospital, 41 Ethnikis Aminis St., Thessaloniki, 546 35, Greece
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Leung J, Rahim N. The role of covered self-expandable metallic stents in malignant biliary strictures. Gastrointest Endosc 2006; 63:1001-3. [PMID: 16733116 DOI: 10.1016/j.gie.2006.02.011] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2006] [Accepted: 02/05/2006] [Indexed: 02/08/2023]
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Somogyi L, Chuttani R, Croffie J, DiSario J, Liu J, Mishkin DS, Shah R, Tierney W, Wong Kee Song LM, Petersen BT. Biliary and pancreatic stents. Gastrointest Endosc 2006; 63:910-9. [PMID: 16733103 DOI: 10.1016/j.gie.2006.01.013] [Citation(s) in RCA: 36] [Impact Index Per Article: 1.9] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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Soderlund C, Linder S. Covered metal versus plastic stents for malignant common bile duct stenosis: a prospective, randomized, controlled trial. Gastrointest Endosc 2006; 63:986-95. [PMID: 16733114 DOI: 10.1016/j.gie.2005.11.052] [Citation(s) in RCA: 230] [Impact Index Per Article: 12.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/04/2005] [Accepted: 11/08/2005] [Indexed: 12/12/2022]
Abstract
BACKGROUND Most patients with malignant common bile duct strictures are suited only for palliation of jaundice by placement of a polyethylene (PE) stent using an endoscopic retrograde cholangiographic technique. Occlusion of these stents occurs after 3 to 4 months, whereas uncovered self-expanding metal stents (SEMS) remain open twice as long. The initial higher cost of the latter might be balanced by a decreased need for repeat intervention. OBJECTIVE To compare the patency of 10F PE stents and covered 30F steel SEMS (Wallstent; Boston Scientific Nordic AB, Helsingborg, Sweden). DESIGN Single-center, prospective, randomized, controlled trial. SETTING General hospital in Stockholm, Sweden, which has a catchment area of 0.6 million people. PATIENTS Non-referred, unresectable malignant common bile duct strictures. INTERVENTIONS Endoscopic retrograde cholangiography with plastic stents or covered SEMS. MAIN OUTCOME MEASUREMENTS Time to stent failure, requiring a new stent. LIMITATIONS Similar setting and patients, and costs in Scandinavia. RESULTS Fifty-one and 49 patients were allocated to the PE stent and SEMS groups, respectively. Fifty-six patients died without stent failure within 10 months (median, 2.6 months). Twenty-two PE stent and 9 SEMS patients (P = .009) developed failure after a median of 1.1 and 3.5 months, respectively (P = .007). Median patency times were 1.8 and 3.6 months in the PE and SEMS groups, respectively (P = .002). Median survival was 4.5 months; in 35 patients with distant metastases, the median survival was 2.5 months (P = .002)(PE group, 1.9 months). CONCLUSIONS The more-effective SEMS are recommended in unresectable patients with malignant common bile duct strictures, who survive a median of 4.5 months. Less costly plastic stents are preferable in the one third of patients who have distant metastases. In our study, the cost was equal.
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Affiliation(s)
- Claes Soderlund
- Karolinska Institutet, Upper GI Surgery, Department of Surgery, South Hospital, SE 118-83 Stockholm, Sweden
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Park DH, Kim MH, Choi JS, Lee SS, Seo DW, Kim JH, Han J, Kim JC, Choi EK, Lee SK. Covered versus uncovered wallstent for malignant extrahepatic biliary obstruction: a cohort comparative analysis. Clin Gastroenterol Hepatol 2006; 4:790-6. [PMID: 16716757 DOI: 10.1016/j.cgh.2006.03.032] [Citation(s) in RCA: 106] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS We examined the use of both covered and uncovered Wallstents in patients with malignant extrahepatic biliary obstruction to determine whether use of covered Wallstents prolonged stent patency without increasing procedure-related complications. METHODS Commercially available silicone-covered Wallstents were prospectively evaluated in 98 patients who underwent insertion from December 2002-December 2004. Those data were compared with data obtained by retrospectively studying 108 consecutive patients who underwent endoscopic insertion of uncovered Wallstents between January 2000-November 2002, and for whom accurate and complete follow-up details were available. RESULTS The mean stent patency was similar for both groups, 148.9 days (range, 3-667 days) for covered Wallstents and 143.5 days (3-910 days) for uncovered Wallstents (P = .531). The 2 groups also did not significantly differ in terms of cumulative stent patency according to the Kaplan-Meier lifetime table. The incidence of mild pancreatitis was similar in both groups, occurring in 6 patients with covered stents (6/98, 6.1%) and 2 patients with uncovered stents (2/108, 1.9%) (P = .154). Excluding those patients who had previously undergone cholecystectomy, acute cholecystitis occurred in 5 of 88 patients with covered Wallstents (6.1%) and 1 of 100 patients with uncovered stents (1%) (P = .104). Stent migration occurred in 6 patients with covered stents (6.1%) and 0 patients with uncovered stents (P = .011). CONCLUSION Covered Wallstents might not prolong stent patency compared with uncovered Wallstents when used in the management of malignant extrahepatic biliary obstruction.
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Affiliation(s)
- Do Hyun Park
- Department of Internal Medicine, Soon Chun Hyang University Cheonan Hospital, Cheonan, Korea
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Moss AC, Morris E, MacMathuna P, Cochrane Upper GI and Pancreatic Diseases Group. Palliative biliary stents for obstructing pancreatic carcinoma. Cochrane Database Syst Rev 2006; 2006:CD004200. [PMID: 16625598 PMCID: PMC6769023 DOI: 10.1002/14651858.cd004200.pub4] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND Palliative endoscopic stents or surgical by-pass are often required for inoperable pancreatic carcinoma to relieve symptomatic obstruction of the distal biliary tree. The optimal method of intervention remains unknown. OBJECTIVES To compare surgery, metal endoscopic stents and plastic endoscopic stents in the relief of distal biliary obstruction in patients with inoperable pancreatic carcinoma. SEARCH STRATEGY We searched the databases of the Cochrane Upper Gastrointestinal and Pancreatic Group specialised register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CancerLit, Current Concepts Database and BIDS (September 2002 to September 2004). The searches were re-run in December 2005 and we are awaiting further details on two trials. Reference lists of articles and published abstracts from UEGW and DDW were hand-searched. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing surgery to endoscopic stenting, endoscopic metal stents to plastic stents, and different types of endoscopic plastic and metal stents, used to relieve obstruction of the distal bile duct in patients with inoperable pancreatic carcinoma. DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data. Adverse effects information was collected from the trials. MAIN RESULTS Twenty-one trials involving 1,454 people were included. Based on meta-analysis, endoscopic stenting with plastic stents appears to be associated with a reduced risk of complications (RR 0.60, 95% CI 0.45 - 0.81), but with higher risk of recurrent biliary obstruction prior to death (RR 18.59, 95% CI 5.33 - 64.86) when compared with surgery. There was a trend towards higher 30-day mortality in the surgical group (p=0.07, RR 0.58, 95% CI 0.32, 1.04). There was no evidence of a difference in technical or therapeutic success. Other outcomes were not suitable for meta-analysis. No trials comparing endoscopic metal stents to surgery were identified. In endoscopic stent comparisons, metal biliary stents appear to have a lower risk of recurrent biliary obstruction than plastic stents (RR 0.52, 95% CI 0.39 - 0.69). There was no significant statistical difference in technical success, therapeutic success, complications or 30-day mortality using meta-analysis. A narrative review of studies of the cost-effectiveness of metal stents drew conflicting conclusions, but results may be dependent on the patients' length of survival.Neither Teflon, hydrourethane, or hydrophilic coating appear to improve the patency of plastic stents above polyethylene in the trials reviewed. Only perflouro alkoxy plastic stents had superior outcome to polyethylene stents in one trial. The single eligible trial comparing types of metal stents reported higher patency with covered stents, but also a higher risk of complications. These results are based on review of the trials individual results only. AUTHORS' CONCLUSIONS Endoscopic metal stents are the intervention of choice at present in patients with malignant distal obstructive jaundice due to pancreatic carcinoma. In patients with short predicted survival, their patency benefits over plastic stents may not be realised. Further RCTs are needed to determine the optimal stent type for these patients.
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Affiliation(s)
- Alan C Moss
- Beth Israel Deaconess Medical CenterCenter for Inflammatory Bowel DiseaseRabb/Rose 1, EastBrookline AveBostonMAUSA02215
| | - Eva Morris
- University of LeedsCancer Epidemiology GroupLevel 6, Bexley WingSt James Institute of OncologyLeedsWest YorkshireUKLS9 7TF
| | - Padraic MacMathuna
- Mater Misericordiae University HospitalEccles StreetDublinIrelandDublin 7
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Nakai Y, Isayama H, Komatsu Y, Tsujino T, Toda N, Sasahira N, Yamamoto N, Hirano K, Tada M, Yoshida H, Kawabe T, Omata M. Efficacy and safety of the covered Wallstent in patients with distal malignant biliary obstruction. Gastrointest Endosc 2005; 62:742-8. [PMID: 16246690 DOI: 10.1016/j.gie.2005.06.030] [Citation(s) in RCA: 111] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/22/2004] [Accepted: 06/08/2005] [Indexed: 02/06/2023]
Abstract
BACKGROUND The aim of this study was to evaluate the efficacy and the safety of the covered Wallstent, a commercially available silicone-covered, self-expandable metallic stent (covered Wallstent), for the treatment of distal malignant biliary obstruction. METHODS Sixty-nine consecutive patients with unresectable distal malignant biliary obstruction who underwent covered Wallstent placement between October 2001 and October 2003 were studied at 4 affiliated hospitals. RESULTS Mean stent patency and mean survival were 139.1 days and 200.9 days, respectively. Stent occlusion occurred in 7 cases (10.1%), but tumor ingrowth was not observed. Seventeen complications, including 5 cholangitis (7.2%), 4 stent migration (5.8%), 4 cholecystitis (5.8%), and 4 pancreatitis (5.8%) were observed in 16 patients (23.2%). Stent misplacement was observed in 7 patients (10.1%). CONCLUSIONS Covered Wallstent is effective in preventing tumor ingrowth for the treatment of distal malignant biliary obstruction. However, the overall complication rate may be higher than uncovered self-expanding metal stents and covered self-expanding metal stents of different design.
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Affiliation(s)
- Yousuke Nakai
- Department of Gastroenterology, Faculty of Medicine, University of Tokyo, Japan
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Hammarström LE. Endobiliary stents for palliation in patients with malignant obstructive jaundice. J Clin Gastroenterol 2005; 39:413-21. [PMID: 15815210 DOI: 10.1097/01.mcg.0000159270.35609.3a] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND Endobiliary drainage for malignant obstructive jaundice presents a viable palliative alternative. Its role and efficacy depend on factors related to the stent, procedure, and patient. GOALS To review the evidence in the literature in which settings plastic or metal stents are cost-effective, and whether adjuvant measures or patient-related factors affect duration of stent patency. STUDY Using databases a literature search was performed for papers published from 1979 to April 2004. All retrieved papers reporting experimental or clinical observations were rated according to strength of evidence, and carefully analyzed. RESULTS AND CONCLUSIONS Metal stents (Wallstent) stay patent longer than plastic stents (large-bore polyethylene with side-holes), overall median 250 and 110 days, respectively, and seem cost-effective in patients with longer than about 6 months survival, which cannot be accurately predicted. Antibiotics or choleretic agents do not prolong stent patency in clinical settings. In case of stent occlusion, indicated stent exchanges and insertion of a plastic stent, respectively, seem cost-effective in patients initially treated with plastic and metal stents.
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Chen Y, Wang XL, Yan ZP, Cheng JM, Wang JH, Gong GQ, Qian S, Luo JJ, Liu QX. HDR- 192Ir intraluminal brachytherapy in treatment of malignant obstructive jaundice. World J Gastroenterol 2004; 10:3506-10. [PMID: 15526374 PMCID: PMC4576236 DOI: 10.3748/wjg.v10.i23.3506] [Citation(s) in RCA: 43] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
AIM: To determine the feasibility and safety of intraluminal brachytherapy in treatment of malignant obstructive jaundice (MOJ) and to evaluate the clinical effect of intraluminal brachytherapy on stent patency and patient survival.
METHODS: Thirty-four patients with MOJ were included in this study. Having biliary stent placed, all patients were classified into intraluminal brachytherapy group (group A, n = 14) and control group (group B, n = 20) according to their own choice. Intraluminal brachytherapy regimen included: HDR-192Ir was used in the therapy, fractional doses of 4-7 Gy were given every 3-6 d for 3-4 times, and standard points were established at 0.5-1.0 cm. Some patients of both groups received transcatheter arterial chemoembolization (TACE) after stent placement.
RESULTS: In group A, the success rate of intraluminal brachytherapy was 98.0%, RTOG grade 1 acute radiation morbidity occurred in 3 patients, RTOG/EORTC grade 1 late radiation morbidity occurred in 1 patient. Mean stent patency of group A (12.6 mo) was significantly longer than that of group B (8.3 mo) (P < 0.05). There was no significant difference in the mean survival (9.4 mo vs 6.0 mo) between the two groups.
CONCLUSION: HDR-192Ir intraluminal brachytherapy is a safe palliative therapy in treating MOJ, and it may prolong stent patency and has the potentiality of extending survival of patients with MOJ.
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Affiliation(s)
- Yi Chen
- Department of Radiology, Affiliated Zhongshan Hospital, Medical Center of Fudan University, Shanghai 200032, China
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Hasebe O, Arakura N, Imai Y, Nagata A. FACTORS AFFECTING THE PATENCY OF EXPANDABLE METALLIC STENT FOR MALIGNANT BILIARY OBSTRUCTION. Dig Endosc 2004. [DOI: 10.1111/j.1443-1661.2004.00397.x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/23/2023]
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