Biliary Tract Diseases, ERCP Training, Pancreatic Diseases
Conditions
Brief summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging procedure. It takes time to learn the basic skills and need at least 180 - 200 cases for trainees to achieve competency in ERCP. Hands-on practice in patients remains the gold standard for ERCP training. Traditional hands-on ERCP training requires the trainer to be on-site to assist the trainee with ERCP operations. We hypothesized that the trainee can be safely guided by trainer off-site with interactive audio and endoscopic and fluoroscopic view. Technology-enabled health care at a distance has profound scientific potential and accordingly has been met with growing interest. Teleguidance facilitated ERCP cannulation is a strategy to provide expert cannulation guidance to trainee in settings where such expertise is not on-site. Teleguidance not only reduces unnecessary radiation exposure of endoscopist, but also provides remote assistance for trainees to complete training or further improve skills. Given the advantages of the off-site teleguidance, it could be an attractive substitute for on-site hands-on ERCP training. The primary aim of this study was to evaluate whether off-site assistance (Off group) could achieve a comparable success rate to on-site assistance (On group) regarding the rates of successful selective biliary cannulation during ERCP training.
Interventions
PROCEDUREOff-site assistance
The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-90 years old * With native papilla
Exclusion criteria
* History of partial or total gastrectomy (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of selective cannulation by trainee | up to one year | The rate of successful selective cannulation by trainee during the training period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | up to one year | Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery）; Bleeding (mild, moderate, severe); |
| Performance score of selective cannulation | up to one year | The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better |
| Final success rate of cannulation | up to one year | The overall rate of successful selective cannulation by trainee and trainer |
| Total time of successful cannulation | up to one year | Total time required for successful cannulation |
| Radiation exposure time | up to one year | Radiation exposure time for trainee and trainer |
Countries
China
Contacts
Primary ContactYanglin Pan, M.D.
Backup ContactHui Luo, M.D.
Outcome results
None listed