Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training

May 28, 2023 updated by: Yanglin Pan, Air Force Military Medical University, China

Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial

Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skills and need at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. Traditional hands-on ERCP training requires the trainer to be on-site to assist the trainee with ERCP operations. We hypothesized that the trainee can be safely guided by trainer off-site with interactive audio and endoscopic and fluoroscopic view. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. Teleguidance facilitated ERCP cannulation is a strategy to provide expert cannulation guidance to trainee in settings where such expertise is not on-site. Teleguidance not only reduces unnecessary radiation exposure of endoscopist, but also provides remote assistance for trainees to complete training or further improve skills. Given the advantages of the off-site teleguidance, it could be an attractive substitute for on-site hands-on ERCP training.

The primary aim of this study was to evaluate whether off-site assistance (Off group) could achieve a comparable success rate to on-site assistance (On group) regarding the rates of successful selective biliary cannulation during ERCP training.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hui Luo, M.D.
  • Phone Number: 86-20-84771536
  • Email: fmmulh@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Endoscopic center, Xijing Hospital of Digestive Diseases
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-90 years old
  • With native papilla

Exclusion Criteria:

  • History of partial or total gastrectomy (Billroth I/II, Roux-en-Y)
  • Type II duodenal stenosis
  • Previously failed cannulation
  • Chronic pancreatitis with stones in the pancreatic head
  • Hemodynamic instability
  • Lactating or pregnant women
  • Inability to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Off-site assistance group
The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom. The trainer was not allowed to enter the procedure room and touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation.
Procedure: Off-site assistance
The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom.
No Intervention: On-site assistance group
The trainer supervised the trainee's cannulation operation in the procedure room. The trainer was allowed to provide unlimited verbal instructions to the trainee on-site. The trainer was not allowed to touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of selective cannulation by trainee
Time Frame: up to one year
The rate of successful selective cannulation by trainee during the training period.
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: up to one year
Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery）; Bleeding (mild, moderate, severe);
up to one year
Radiation exposure time
Time Frame: up to one year
Radiation exposure time for trainee and trainer
up to one year
Performance score of selective cannulation
Time Frame: up to one year
The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better
up to one year
Final success rate of cannulation
Time Frame: up to one year
The overall rate of successful selective cannulation by trainee and trainer
up to one year
Total time of successful cannulation
Time Frame: up to one year
Total time required for successful cannulation
up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2020

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20201005-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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