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

A

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

ERCP Training

Treatments

Behavioral: The assistance type during ERCP

Study type

Interventional

Funder types

Other

Identifiers

NCT06197815
KY20232429

Details and patient eligibility

About

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.

Enrollment

754 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Patients aged 18-90 years who received ERCP
  2. Patients with native papilla

Exclusion criteria

  1. Patients with altered anatomy (Billroth I/II, Roux-en-Y)
  2. Type II duodenal stenosis
  3. Previously failed cannulation
  4. Chronic pancreatitis with stones in the pancreatic head
  5. Hemodynamic instability
  6. Lactating or pregnant women
  7. Inability to give written informed consent

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

754 participants in 2 patient groups

Off-site assistance group
Experimental group
Description:
The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic view. Trainees wear headphones, and trainers use intercom to provide the unlimited verbal instructions. The trainer was not allowed into the procedure room and touched the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. Then the trainer would then take over and continue with the cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications.
Treatment:
Behavioral: The assistance type during ERCP
Hands-on assistance group
Active Comparator group
Description:
During trainees' attempted cannulation, the trainer gave unlimited verbal instructions with hands-on assistance limited to only adjustment of scope position if necessary. To avoid unintended cannulation, the trainer was not allowed to touch the control section of the scope or the sphincterotome used for cannulation. However, the trainer would correct any inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. The trainees could ask for help or stop cannulation at any time if they were not comfortable continuing the procedure. The trainer would then take over and continue with the cannulation.
Treatment:
Behavioral: The assistance type during ERCP

Trial contacts and locations

3

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Central trial contact

Xu Wang; Yanglin Pan, MD

Data sourced from clinicaltrials.gov

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