Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

NCT ID: NCT01598142

Last Updated: 2012-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2011-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Biliary Diseases Pancreas Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experienced assistant group

experienced endoscopist with an experienced assistant.

Group Type OTHER

Team 1

Intervention Type PROCEDURE

experienced endoscopist with a experienced assistant

new trained assistant group

same experienced endoscopist with a new trained assistant

Group Type OTHER

Team 2

Intervention Type PROCEDURE

same experienced endoscopist with a new trained assistant

Interventions

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Team 1

experienced endoscopist with a experienced assistant

Intervention Type PROCEDURE

Team 2

same experienced endoscopist with a new trained assistant

Intervention Type PROCEDURE

Other Intervention Names

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experienced new trained

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qi-yong Li

OTHER

Sponsor Role lead

Responsible Party

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Qi-yong Li

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Qi-Yong Li, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

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The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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YLS2011-105

Identifier Type: -

Identifier Source: org_study_id

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