Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05888012
• Other study ID #: Basket vs. Balloon
• Status: Completed
• Start date: February 1, 2012
• Est. completion date: April 10, 2023

Study information

• Verified date: May 2023
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6493
• Est. completion date: April 10, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Device:
• basket catheter
Stone extraction is completed with either a basket or balloon catheter at the time of ERCP. The basket catheter is made of nickel-titanium wires which can be manipulated to trap and withdraw stones.
• balloon catheter
Stone extraction is completed with either a basket or balloon catheter at the time of ERCP. The balloon catheter is made of latex, which is inflated after passing the stone, thus pushing the stone outwards.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of stone clearance in basket and balloon catheter groups	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.	1 year after ERCP
Secondary	the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups	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	1 year after ERCP