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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Pancreatitis Benign Biliary Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fully covered self-expanding metal stent

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

single plastic stent

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.

Group Type EXPERIMENTAL

endoscopic retrograde biliary drainage (single plastic stent)

Intervention Type 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.

Interventions

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

Intervention Type DEVICE

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 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older;
2. Patients diagnosed with CP;
3. 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;
4. Confirmation of bile duct stricture by imaging assessment.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No