Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

Completed

• Conditions: Chronic Pancreatitis

• Registration Number: NCT05888012
• Lead Sponsor: Changhai Hospital

Brief Summary

The aim of the study is to compare the safety and efficacy of the basket catheter with that of the balloon catheter for endoscopic extraction of pancreatic stones.

Detailed Description

This is a retrospective cohort study. Patients with chronic pancreatitis who underwent ERCP for pancreatic duct stone extraction using either a basket or a balloon catheter were enrolled in this study.

Study Timeline

• Study Start: 2012-02-01
• Primary Completion: 2021-12-31
• Study Completion: 2023-04-10
• Status Verified: 2023-05
• Study First Submitted: 2023-05-07
• Study First Submitted QC: 2023-05-24
• Last Update Submitted: 2023-05-24
• Study First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6493

Inclusion Criteria

• CP patients with main pancreatic duct (MPD) stones who underwent ERCP

Exclusion Criteria

• Patients had undergone pancreatic surgery or gastrectomy with Billroth II reconstruction prior to the ERCP procedure
• Patients were suspected of having a malignant tumor
• Patients combined with bile duct stones
• Patients had severe pancreatic duct structure
• Patients with insufficient clinical data
• Patients with previous ERCP treatment
• Patients had received both catheters

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the rate of stone clearance in basket and balloon catheter groups	1 year after ERCP	complete clearance, defined as fragmentation of the pancreatic stones to \< 3 mm and clearance of more than 90% of the fragments; partial clearance, defined as clearance of 50-90% of the fragments; and unsuccessful clearance, defined as the presence of pancreatic stones ≥ 3 mm or clearance of less than 50% of the fragments.

Secondary Outcome Measures

Name	Time	Method
the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups	1 year after ERCP	ERCP peri-procedural outcomes included difficult cannulation, endoscopic sphincterotomy, dilation of stenosis, and extraction through the minor papilla. Major post-ERCP complications, which were defined according to the Consensus Criteria, included post-ERCP pancreatitis (PEP), bleeding, infection, perforation, and basket impaction

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China