Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pancreatitis

Intervention / Treatment
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* Device: basket catheter
* Device: balloon catheter


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|
|Device: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic stone, Endoscopic retrograde cholangiopancreatography (ERCP), Basket catheter, Balloon catheter, Stone clearance