Balloon Catheter vs. Basket Catheter in Pancreatic Duct Stone Clearance

NCT05888012 | Completed DMC

• 1 other identifier: Basket vs. Balloon
• Study Type: observational
• Target: 6,493
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pancreatitis

Keywords

Pancreatic stone; Endoscopic retrograde cholangiopancreatography (ERCP); Basket catheter; Balloon catheter; Stone clearance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the rates of ERCP peri-procedural outcomes and the rates of complications of ERCP in basket and balloon catheter groups

  1 year after ERCP

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• CP patients with main pancreatic duct (MPD) stones who underwent ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhuan Liao

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: June 5, 2023
• Study Start: February 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: April 10, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-05

Locations

CN (1)