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

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

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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