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Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598142
First Posted: May 15, 2012
Last Update Posted: May 15, 2012
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.
Information provided by (Responsible Party):
Qi-yong Li, Zhejiang University
  Purpose
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

Condition Intervention
Biliary Diseases Pancreas Diseases Procedure: Team 1 Procedure: Team 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Qi-yong Li, Zhejiang University:

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

Secondary Outcome Measures:
  • Incidences of post-ERCP pancreatitis [ Time Frame: two years ]
  • Incidences of bleeding [ Time Frame: two years ]
  • Incidences of perforation [ Time Frame: two years ]
  • Incidences of infection [ Time Frame: two years ]
  • Number of attempts at cannulation [ Time Frame: two years ]
  • Cannulation time [ Time Frame: two years ]

Enrollment: 465
Study Start Date: October 2007
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01598142


Locations
China, Zhejiang
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Qi-yong Li
Investigators
Principal Investigator: Qi-Yong Li, MD Zhejiang University
  More Information

Responsible Party: Qi-yong Li, Clinical Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01598142     History of Changes
Other Study ID Numbers: YLS2011-105
First Submitted: November 1, 2011
First Posted: May 15, 2012
Last Update Posted: May 15, 2012
Last Verified: May 2012

Keywords provided by Qi-yong Li, Zhejiang University:
Endoscopic retrograde cholangiopancreatography (ERCP)
Guidewires
Cannulation
Single-operator
C-Hook

Additional relevant MeSH terms:
Pancreatic Diseases
Gallbladder Diseases
Digestive System Diseases
Biliary Tract Diseases