Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

May 24, 2023 updated by: Zhuan Liao, Changhai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6493

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

CP patients with pancreatic duct stones who underwent ERCP between February 2012 and December 2021were identified. The diagnosis of CP was established based on computed tomography, magnetic resonance imaging or endoscopic ultrasound examinations.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of stone clearance in basket and balloon catheter groups
Time Frame: 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.
1 year after ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups
Time Frame: 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
1 year after ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhuan Liao, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

May 7, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Basket vs. Balloon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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