Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

Biliary Diseases Clinical Trial

Official title:

Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598142
• Other study ID #: YLS2011-105
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: May 14, 2012
• Start date: October 2007
• Est. completion date: February 2011

Study information

• Verified date: May 2012
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Diseases
• Gallbladder Diseases
• Pancreas Diseases
• Pancreatic Diseases

Intervention

Procedure:
• Team 1
experienced endoscopist with a experienced assistant
• Team 2
same experienced endoscopist with a new trained assistant

Locations

Country	Name	City	State
China	The First Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Qi-yong Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cannulation success rate		two years	Yes
Secondary	Incidences of post-ERCP pancreatitis		two years	Yes
Secondary	Incidences of bleeding		two years	Yes
Secondary	Incidences of perforation		two years	Yes
Secondary	Incidences of infection		two years	Yes
Secondary	Number of attempts at cannulation		two years	Yes
Secondary	Cannulation time		two years	Yes