Clinical trial NCT05249400: Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
Official title: Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERCP Training
Biliary Tract Diseases
Pancreatic Diseases
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 600
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: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success rate of selective cannulation by trainee
timeFrame: up to one year
Secondary outcomes:
measure: Complication rate
timeFrame: up to one year
measure: Performance score of selective cannulation
timeFrame: up to one year
measure: Final success rate of cannulation
timeFrame: up to one year
measure: Total time of successful cannulation
timeFrame: up to one year
measure: Radiation exposure time
timeFrame: up to one year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
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