Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

May 14, 2012 updated by: Qi-yong Li, Qi-Yong Li

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

465

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • the First Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: experienced assistant group
experienced endoscopist with an experienced assistant.
Procedure: Team 1
experienced endoscopist with a experienced assistant
Other Names:
  • experienced
Other: new trained assistant group
same experienced endoscopist with a new trained assistant
Procedure: Team 2
same experienced endoscopist with a new trained assistant
Other Names:
  • new trained

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cannulation success rate
Time Frame: two years
two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidences of post-ERCP pancreatitis
Time Frame: two years
two years
Incidences of bleeding
Time Frame: two years
two years
Incidences of perforation
Time Frame: two years
two years
Incidences of infection
Time Frame: two years
two years
Number of attempts at cannulation
Time Frame: two years
two years
Cannulation time
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qi-Yong Li

Investigators

  • Principal Investigator: Qi-Yong Li, MD, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YLS2011-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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