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

NCT06655051 | Recruiting DMC FDA Device

• 1 other identifier: ESSENCE202405
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pancreatitis; Benign Biliary Stricture

Keywords

chronic pancreatitis; benign biliary stricture; ERCP; ERBD; stent

Outcome Measures

Primary Outcomes (1)

• Long-term stricture resolution

  Stricture resolution assessed at the time of final stent removal as well as the absence of objective findings of stricture recurrence during the 18 months, post-stenting follow-up period.

  2 years after enrollment

Secondary Outcomes (6)

• Early clinical success

  6 months after enrollment

• Technical success

  6 months after enrollment

• Adverse events related to the device or procedure

  2 years after enrollment

• Length of stent placement and removal procedures

  6 months after enrollment

• Number of ERCP procedures after Initial stent placement.

  6 months after enrollment

Study Arms (2)

Fully covered self-expanding metal stent

ACTIVE COMPARATOR

A single biliary fcSEMS will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture.

Device: endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent)

single plastic stent

EXPERIMENTAL

A single biliary plastic stent will be placed under ERCP. During stenting period , if symptoms of biliary obstruction occur due to stent occlusion or migration, ERCP replacement or implantation of a new stent should be performed according to the condition. After 6 months of stenting, imaging evaluation will be performed. ERCP is not needed if the stent undergoes spontaneous complete distal migration and the patient is asymptomatic and has normal liver function. If the stent is visible, ERCP will be performed to remove the stent and the stricture will be evaluated. If stricture persists after 6 months of stenting, a follow-up treatment plan should be developed through multidisciplinary discussion. One month after ERCP, complications will be followed up by telephone. Follow-up after biliary stent removal will be conducted to inquire about symptoms, signs and liver function test results, and to evaluate the recurrence of biliary stricture.

Device: endoscopic retrograde biliary drainage (single plastic stent)

Interventions

endoscopic retrograde biliary drainage (single plastic stent) DEVICE

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 to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.

single plastic stent

endoscopic retrograde biliary drainage ( fully covered self-expanding metal stent) DEVICE

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 months after stenting to confirm spontaneous passage of the biliary duct stent, and the stent will be removed via ERCP if it is still in place.

Fully covered self-expanding metal stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Shanghai Changhai Hospital Clinical Research Ward

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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-0822-0832. Epub 2019 Jan 17.

  PMID: 30654394 BACKGROUND

• 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. 2014 Aug;147(2):385-95; quiz e15. doi: 10.1053/j.gastro.2014.04.043. Epub 2014 May 4.

  PMID: 24801350 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Strictures Secondary to Chronic Pancreatitis: A Multicenter Randomized Trial. Gastroenterology. 2021 Jul;161(1):185-195. doi: 10.1053/j.gastro.2021.03.015. Epub 2021 Mar 17.

  PMID: 33741314 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoshen Li, M.D.

  Changhai Hospital

  STUDY CHAIR

• Liang-Hao Hu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lianghao Hu, M.D.

CONTACT

+86-13817593520; lianghao-hu@smmu.edu.cn

Zhaoshen Li, M.D.

CONTACT

+86-13901960921; zhaoshen-li@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2024
• First Posted: October 23, 2024
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)