Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05888012

Collaborator

(none)

6,493

Enrollment

Location

134.2

Actual Duration (Months)

48.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Device: basket catheter Device: balloon catheter

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 Design

Study Type:

Observational

Actual Enrollment :

6493 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy and Safety Comparison of Balloon Catheter and Basket Catheter for Endoscopic Pancreatic Duct Stone Clearance

Actual Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Apr 10, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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