ERCP Training
Conditions
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.
Interventions
BEHAVIORALThe 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
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of successful biliary cannulation | 10 minutes | The percentage of trainee successfully biliary cannulation |
Secondary
| Measure | Time frame |
|---|---|
| Cannulation time | 1 day |
| Competency score from the trainer and endoscopic video | 1 day |
| Incidences of PEP and other adverse events | 1 month |
| Ionizing radiation time | 1 day |
Countries
China
Contacts
Primary ContactYanglin Pan, MD
Backup ContactXu Wang
Outcome results
None listed