Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: ERCP Training; Pancreatic Diseases; Biliary Tract Diseases

Treatments: Procedure: Off-site assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT05249400

KY20201005-2

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 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 and fluoroscopic view. The trainer was allowed to provide unlimited verbal instructions to the trainee by an intercom. The trainer was not allowed to enter the procedure room and touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation.

Treatment:

Procedure: Off-site assistance

On-site assistance group

No Intervention group

Description:

The trainer supervised the trainee's cannulation operation in the procedure room. The trainer was allowed to provide unlimited verbal instructions to the trainee on-site. The trainer was not allowed to touch the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. Then the trainer would then take over and continue with the cannulation.