RecruitingNot ApplicableNCT06655051

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

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

Sponsor

Changhai Hospital

Enrollment

134 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pancreatitis Benign Biliary Stricture

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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.

Exclusion Criteria12

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.

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Interventions

DEVICEendoscopic 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.

DEVICEendoscopic 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.