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Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP

NCT06197815 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2024-01-17

No results posted yet for this study

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skill and at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. It required the trainer to stand by the trainee in the procedure room to assist. There were insufficient patients for most trainees to achieve competence until the trainee graduate. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. We hypothesized that the trainee can be safely guided by a senior trainer off-site with the endoscopic view displayed on a screen. Using the teleguidance, the trainer can even continue to provide guidance when the trainees complete their training and return to their hospitals until they achieve the recommended clinical competency. Given the advantages of the off-site teleguidance, it could be an attractive substitute for hands-on assistance to ERCP training.

The primary aim of this study was to evaluate whether off-site assistance (OA group) could achieve a comparable success rate to standard hands-on assistance (HA group) with regard to the rates of successful selective biliary cannulation during ERCP training.

Conditions

  • ERCP Training

Interventions

BEHAVIORAL

The assistance type during ERCP

The senior trainer guides the trainees during ERCP procedure outside the operating room using communication equipment and the screen displaying an endoscopic view.

Sponsors & Collaborators

  • Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University

    collaborator UNKNOWN

  • Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University

    collaborator UNKNOWN

  • Air Force Military Medical University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2024-06-30
Completion
2024-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197815 on ClinicalTrials.gov