Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
Recruiting now · Not applicable
Conditions studied: Chronic Pancreatitis, Benign Biliary Stricture
In brief
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.
Key facts
- Study ID
- NCT06655051
- Run by
- Changhai Hospital
- People needed
- 134
- Starts
- 2025-04-30
- Expected to finish
- 2030-12-31
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Shanghai Changhai Hospital Clinical Research Ward — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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