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Clinical Trials/NCT06197815
NCT06197815
Recruiting
Not Applicable

Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study

Air Force Military Medical University, China3 sites in 1 country754 target enrollmentDecember 3, 2020
ConditionsERCP Training

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ERCP Training
Sponsor
Air Force Military Medical University, China
Enrollment
754
Locations
3
Primary Endpoint
Rates of successful biliary cannulation
Status
Recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 3, 2020
End Date
August 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Air Force Military Medical University, China
Responsible Party
Principal Investigator
Principal Investigator

Yanglin Pan

Professor

Air Force Military Medical University, China

Eligibility Criteria

Inclusion Criteria

  • Patients aged 18-90 years who received ERCP
  • Patients with native papilla

Exclusion Criteria

  • Patients with altered anatomy (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

Outcomes

Primary Outcomes

Rates of successful biliary cannulation

Time Frame: 10 minutes

The percentage of trainee successfully biliary cannulation

Secondary Outcomes

  • Competency score from the trainer and endoscopic video(1 day)
  • Incidences of PEP and other adverse events(1 month)
  • Ionizing radiation time(1 day)
  • Cannulation time(1 day)

Study Sites (3)

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