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Completed

NCT Number: NCT05888012

Balloon Catheter vs. Basket Catheter in 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.

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

basket catheter

Device

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

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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