Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

Not Applicable

Completed

• Conditions: Biliary Diseases; Pancreas Diseases
• Interventions: Procedure: Team 1; Procedure: Team 2

• Registration Number: NCT01598142
• Lead Sponsor: Qi-yong Li

Brief Summary

The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

Detailed Description

A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2010-12
• Study Completion: 2011-02
• Study First Submitted: 2011-11-01
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Study First Posted: 2012-05-15
• Last Update Posted: 2012-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 465

Inclusion Criteria

• hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP

Exclusion Criteria

• previous endoscopic sphincterotomy,
• surgically altered anatomy (e.g. Billroth II gastrectomy) or
• diagnostic duodenoscopy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experienced assistant group	Team 1	experienced endoscopist with an experienced assistant.
new trained assistant group	Team 2	same experienced endoscopist with a new trained assistant

Primary Outcome Measures

Name	Time	Method
Cannulation success rate	two years

Secondary Outcome Measures

Name	Time	Method
Incidences of infection	two years
Number of attempts at cannulation	two years
Cannulation time	two years
Incidences of post-ERCP pancreatitis	two years
Incidences of bleeding	two years
Incidences of perforation	two years

Trial Locations

Locations (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China