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Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Qi-yong Li, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01598142
First received: November 1, 2011
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • Cannulation success rate [ Time Frame: two years ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Qi-yong Li, Clinical Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT01598142     History of Changes
Other Study ID Numbers: YLS2011-105
Study First Received: November 1, 2011
Last Updated: May 14, 2012
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 17, 2013