Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis

Официальное название

Efficacy and Safety of Single Plastic Stent Compared With Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Single Center，Prospective，Non-inferiority, Open Label, Randomized, Controlled Trial

Обзор

The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is: Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？ Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.

Подробное описание

Although a number of previous studies have shown that the drainage and dilation effect of a single plastic stent is limited for benign biliary stricture (BBS) secondary to chronic pancreatitis (CP), the poor management of CP itself in most studies may explain the unsatisfactory efficacy of a single biliary plastic stent in relieving CP secondary BBS. Investigators believe that the effective management of CP is an important step to solve the BBS secondary to CP, especially the effective removal of pancreatic duct stones, the relief of pancreatic duct obstruction and the maintenance of pancreatic duct patency. Previous data showed that in CP patients treated with ESWL combined with ERCP, 72.4% could achieve complete removal of main pancreatic duct stones and 90.8% could achieve successful endoscopic decompression. Under the premise of effectively removing the stones of the main pancreatic duct at the head of the pancreas and maintaining the patency of the pancreatic duct, using a single plastic stent for stent drainage of BBS is effective, and a single plastic stent has potential advantages such as lower stent displacement rate and cheaper. Therefore, investigators design a single-center, prospective, open-label, randomized controlled, non-inferiority trial to compare the effectiveness, safety, and cost-effectiveness of a single plastic stent and fcSEMS for the removal of CP secondary BBS under the premise that the primary disease, i.e. CP itself, was effectively managed.

Вмешательства

• Устройство endoscopic retrograde biliary drainage (single plastic stent)
  Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A single plastic stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 months after stenting
• Устройство endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)
  Participants will undergo ERCP. A flexible tube is inserted into the duodenum, crossing the sphincter of Oddi to access the biliary system. And the location, diameter, and length of biliary stricture will be evaluated by injection of contrast media. A fully covered self-expanding metal stent is then placed across the biliary stricture, allowing the bile duct to resume drainage. The participants will be observed closely after ERCP and record complications. Imaging evaluation will be conducted 6 m

Первичные конечные точки

• Long-term stricture resolution [Срок оценки: 2 years after enrollment]

Вторичные конечные точки (6)

• Early clinical success [Срок оценки: 6 months after enrollment]
• Technical success [Срок оценки: 6 months after enrollment]
• Adverse events related to the device or procedure [Срок оценки: 2 years after enrollment]
• Length of stent placement and removal procedures [Срок оценки: 6 months after enrollment]
• Number of ERCP procedures after Initial stent placement. [Срок оценки: 6 months after enrollment]
• Number of stents placed [Срок оценки: 6 months after enrollment]

Критерии участия

Критерии включения

• Age 18 or older;
• Patients diagnosed with CP;
• Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase in total bilirubin or alkaline phosphatase levels(> 2 times the upper limit of normal) for more than 4 weeks;
• Confirmation of bile duct stricture by imaging assessment.

Критерии исключения

• Prior plastic stenting exceeding six months or any metal stenting;
• Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
• Biliary stricture of benign etiology other than chronic pancreatitis;
• Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
• Stricture within 2 cm of common bile duct bifurcation;
• Biliary stricture of malignant etiology;
• Patients with acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations or biliary fistula;
• Symptomatic duodenal stenosis (with gastric stasis);
• Subjects for whom endoscopic techniques are contraindicated;
• Pregnancy, incarceration;
• Life expectancy < 1 year;
• Other conditions that inappropriate to participant in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Changhai Hospital Clinical Research Ward — Шанхай

Публикации

• Ramchandani M, Pal P, Costamagna G. Management of Benign Biliary Stricture in Chronic Pancreatitis. Gastrointest Endosc Clin N Am. 2023 Oct;33(4):831-844. doi: 10.1016/j.giec.2023.04.002. Epub 2023 May 11. PMID 37709414
• Dumonceau JM, Delhaye M, Tringali A, Arvanitakis M, Sanchez-Yague A, Vaysse T, Aithal GP, Anderloni A, Bruno M, Cantu P, Deviere J, Dominguez-Munoz JE, Lekkerkerker S, Poley JW, Ramchandani M, Reddy N, van Hooft JE. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Updated August 2018. Endoscopy. 2019 Feb;51(2):179-193. doi: 10.1055/a-0 PMID 30654394
• Deviere J, Nageshwar Reddy D, Puspok A, Ponchon T, Bruno MJ, Bourke MJ, Neuhaus H, Roy A, Gonzalez-Huix Llado F, Barkun AN, Kortan PP, Navarrete C, Peetermans J, Blero D, Lakhtakia S, Dolak W, Lepilliez V, Poley JW, Tringali A, Costamagna G; Benign Biliary Stenoses Working Group. Successful management of benign biliary strictures with fully covered self-expanding metal stents. Gastroenterology. 20 PMID 24801350
• Haapamaki C, Kylanpaa L, Udd M, Lindstrom O, Gronroos J, Saarela A, Mustonen H, Halttunen J. Randomized multicenter study of multiple plastic stents vs. covered self-expandable metallic stent in the treatment of biliary stricture in chronic pancreatitis. Endoscopy. 2015 Jul;47(7):605-10. doi: 10.1055/s-0034-1391331. Epub 2015 Jan 15. PMID 25590182
• Cote GA, Slivka A, Tarnasky P, Mullady DK, Elmunzer BJ, Elta G, Fogel E, Lehman G, McHenry L, Romagnuolo J, Menon S, Siddiqui UD, Watkins J, Lynch S, Denski C, Xu H, Sherman S. Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial. JAMA. 2016 Mar 22-29;315(12):1250-7. doi: 10.1001/jama.2016.2619. PMID 27002446
• Ramchandani M, Lakhtakia S, Costamagna G, Tringali A, Puspoek A, Tribl B, Dolak W, Deviere J, Arvanitakis M, van der Merwe S, Laleman W, Ponchon T, Lepilliez V, Gabbrielli A, Bernardoni L, Bruno MJ, Poley JW, Arnelo U, Lau J, Roy A, Bourke M, Kaffes A, Neuhaus H, Peetermans J, Rousseau M, Reddy DN. Fully Covered Self-Expanding Metal Stent vs Multiple Plastic Stents to Treat Benign Biliary Strictur PMID 33741314

Идентификаторы

NCT: NCT06655051 · ESSENCE202405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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