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Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598142
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Qi-yong Li, Zhejiang University

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

Condition or disease Intervention/treatment Phase
Biliary Diseases Pancreas Diseases Procedure: Team 1 Procedure: Team 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
Study Start Date : October 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
experienced assistant group
experienced endoscopist with an experienced assistant.
Procedure: Team 1
experienced endoscopist with a experienced assistant
Other Name: experienced

new trained assistant group
same experienced endoscopist with a new trained assistant
Procedure: Team 2
same experienced endoscopist with a new trained assistant
Other Name: new trained

Primary Outcome Measures :
  1. Cannulation success rate [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Incidences of post-ERCP pancreatitis [ Time Frame: two years ]
  2. Incidences of bleeding [ Time Frame: two years ]
  3. Incidences of perforation [ Time Frame: two years ]
  4. Incidences of infection [ Time Frame: two years ]
  5. Number of attempts at cannulation [ Time Frame: two years ]
  6. Cannulation time [ Time Frame: two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01598142

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China, Zhejiang
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Qi-yong Li
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Principal Investigator: Qi-Yong Li, MD Zhejiang University
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Responsible Party: Qi-yong Li, Clinical Professor, Zhejiang University Identifier: NCT01598142    
Other Study ID Numbers: YLS2011-105
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Qi-yong Li, Zhejiang University:
Endoscopic retrograde cholangiopancreatography (ERCP)
Additional relevant MeSH terms:
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Pancreatic Diseases
Gallbladder Diseases
Digestive System Diseases
Biliary Tract Diseases