Clinical trial NCT06197815: Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP
Official title: Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ERCP Training
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
Collaborators: name: Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
name: Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
First posted: 2024-01-09
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rates of successful biliary cannulation
timeFrame: 10 minutes
Secondary outcomes:
measure: Cannulation time
timeFrame: 1 day
measure: Competency score from the trainer and endoscopic video
timeFrame: 1 day
measure: Incidences of PEP and other adverse events
timeFrame: 1 month
measure: Ionizing radiation time
timeFrame: 1 day
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases, Fourth Military Medical University
state: Shaanxi
city: Shanghai
country: China
facility: Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
state: Shanghai
Study officials:
References: