Long-Term Outcomes of Different Stents for Benign Biliary Strictures Caused by Chronic Pancreatitis

Completed

• Conditions: Stenting Treatment; ERCP; ESWL; Chronic Pancreatitis; Benign Biliary Strictures

• Registration Number: NCT06981975
• Lead Sponsor: Changhai Hospital

Brief Summary

This observational study aims to observe and compare the long-term effectiveness and safety of different types of stents for benign biliary strictures secondary to chronic pancreatitis.

Detailed Description

Chronic pancreatitis (CP) is a debilitating condition that often results in the development of benign biliary strictures (BBS), which significantly contribute to morbidity. BBS are prevalent among a substantial number of CP patients, causing complications such as cholestasis and jaundice. Endoscopic biliary stenting has traditionally been the primary treatment for BBS, initially employing single plastic stents (SPS), which yielded suboptimal outcomes.

Nowadays, fully covered self-expanding metal stents (fcSEMS) and multiple plastic stents (MPS) are considered the first line therapies for BBS caused by CP. However, advancements in lithotripsy and endoscopic retrograde cholangiopancreatography have led to a marked increase in the successful rate of pancreatic duct decompression. This progress necessitates a reevaluation of the effectiveness of SPS.

The objective of this study is to assess and compare the long-term outcomes of various stenting types in patients with BBS due to CP. It is expected that the study's results will provide valuable insights into the optimal stenting strategies for BBS in CP patients. These insights have the potential to greatly influence clinical practice and guide the development of treatment guidelines.

Study Timeline

• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-20
• Study First Posted: 2025-05-21
• Study Start: 2025-05-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Primary Completion: 2025-06-03
• Study Completion: 2025-06-03
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Diagnosis of chronic pancreatitis
• Benign biliary strictures secondary to chronic pancreatitis
• Patients who have undergone endoscopic biliary stenting for the management of BBS between January 2011 and December 2021.
• Complete Treatment Records

Exclusion Criteria

• Patients diagnosed with pancreatic cancer within two years following the diagnosis of CP.
• Incomplete Records of endoscopic biliary stenting treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term clinical success	14 year follow up	Being recurrence-free from the time of initial stent removal or spontaneous stent passage

Secondary Outcome Measures

Name	Time	Method
Early clinical success	1 year since the initial procedure	Benign biliary stricture resolution within 1 year since the initial procedure
Total stenting time	14 year follow up	Total stents placement duration of the initial treatment period (from stent placement to stent removal or spontaneous passage)
Technical success	14 year follow up	Technical success defined as the ability to deploy the stent(s) in satisfactory position during initial stent placement procedure.
Procedure- or device-related adverse events	14 year follow-up	Device or procedure related serious adverse events from the initial stent placement procedure to the 14 year follow-up.
Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures	14 year follow up	Number of Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures during the initial treatment period (excluding ERCP treatment after stricture recurrence)
Total number of stents placed	14 year follow up	Total number of stents placed during the initial treatment period (excluding stents placed for stricture recurrence)
Stricture recurrence	14 year follow up	Abnormalities in liver function tests and the need for repeat intervention after a period of stent removal

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China