NCT06655051 Single Plastic Stent Vs. Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis
| NCT ID | NCT06655051 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | Chronic Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 134 participants in total. It began in 2025-04-30 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Zhaoshen Li, M.D.
STUDY CHAIR
Changhai Hospital
Frequently Asked Questions
Who can join the NCT06655051 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06655051 currently recruiting?
Yes, NCT06655051 is actively recruiting participants. Contact the research team at lianghao-hu@smmu.edu.cn for enrollment information.
Where is the NCT06655051 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06655051 clinical trial?
NCT06655051 is sponsored by Changhai Hospital. The principal investigator is Zhaoshen Li, M.D. at Changhai Hospital. The trial plans to enroll 134 participants.