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

Launched by CHANGHAI HOSPITAL · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two types of stents used to treat a condition called benign biliary stricture, which can happen in people with chronic pancreatitis. The researchers want to see if a single plastic stent works just as well as a fully covered self-expanding metal stent in helping to relieve symptoms caused by this stricture. Participants will be randomly assigned to receive one of these stents, and their progress will be monitored for a total of 18 months.

To be eligible for this study, participants should be 18 years or older, diagnosed with chronic pancreatitis, and have a documented problem with their bile duct that is causing symptoms. However, there are some exclusions, such as those who have had certain types of stenting before or have other serious liver or bile duct conditions. If you join the trial, you can expect to receive one of the stents and have regular check-ups to see how you are doing over the following months. This study aims to find the best treatment option and improve care for patients dealing with this issue.

Gender

ALL

Eligibility criteria

• 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.