Back to resultsSingle-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique
Primary Purpose
Biliary Diseases, Pancreas Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Team 1
Team 2
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Diseases focused on measuring Endoscopic retrograde cholangiopancreatography (ERCP), Guidewires, Cannulation, Single-operator, C-Hook
Eligibility 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
Sites / Locations
- The First Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
experienced assistant group
new trained assistant group
Arm Description
experienced endoscopist with an experienced assistant.
same experienced endoscopist with a new trained assistant
Outcomes
Primary Outcome Measures
Cannulation success rate
Secondary Outcome Measures
Incidences of post-ERCP pancreatitis
Incidences of bleeding
Incidences of perforation
Incidences of infection
Number of attempts at cannulation
Cannulation time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01598142
Brief Title
Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique
Official Title
Single-operator Wire-guided ERCP Cannulation Technique: a Single-center Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qi-yong Li
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Diseases, Pancreas Diseases
Keywords
Endoscopic retrograde cholangiopancreatography (ERCP), Guidewires, Cannulation, Single-operator, C-Hook
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experienced assistant group
Arm Type
Other
Arm Description
experienced endoscopist with an experienced assistant.
Arm Title
new trained assistant group
Arm Type
Other
Arm Description
same experienced endoscopist with a new trained assistant
Intervention Type
Procedure
Intervention Name(s)
Team 1
Other Intervention Name(s)
experienced
Intervention Description
experienced endoscopist with a experienced assistant
Intervention Type
Procedure
Intervention Name(s)
Team 2
Other Intervention Name(s)
new trained
Intervention Description
same experienced endoscopist with a new trained assistant
Primary Outcome Measure Information:
Title
Cannulation success rate
Time Frame
two years
Secondary Outcome Measure Information:
Title
Incidences of post-ERCP pancreatitis
Time Frame
two years
Title
Incidences of bleeding
Time Frame
two years
Title
Incidences of perforation
Time Frame
two years
Title
Incidences of infection
Time Frame
two years
Title
Number of attempts at cannulation
Time Frame
two years
Title
Cannulation time
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi-Yong Li, MD
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Learn more about this trial
Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique
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