Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP

Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP: a Randomized, Controlled, Noninferiority Study

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.

Study Overview

• Status: Recruiting
• Conditions: ERCP Training
• Intervention / Treatment: Behavioral: The assistance type during ERCP

• Study Type: Interventional
• Enrollment (Estimated): 754
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanglin Pan, MD; Phone Number: 86-29-84771536; Email: yanglinpan@hotmail.com
• Study Contact Backup: Name: Xu Wang; Phone Number: 13395437645; Email: wangx5991@163.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
      • Contact: Bo Ning, MD; Phone Number: 13996476336; Email: ningbo.bo@163.com
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Diseases, Fourth Military Medical University
      • Contact: Yanglin Pan, MD; Phone Number: 86-29-84771536; Email: yanglinpan@hotmail.com
  • Shanghai
    • Shanghai, Shanghai, China, 201823
      • Recruiting
      • Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
      • Contact: Mingxing Xia, MD; Phone Number: 13906524284; Email: xiamingxing1982@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Off-site assistance group; The trainer supervised the trainee's cannulation operation outside the procedure room through a high-definition screen displaying the endoscopic view. Trainees wear headphones, and trainers use intercom to provide the unlimited verbal instructions. The trainer was not allowed into the procedure room and touched the endoscope or accessories until the trainee ask for help or failed to achieve deep biliary cannulation. Then the trainer would then take over and continue with the cannulation. The trainer would halt and correct the trainee's inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications.	Behavioral: The 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.
Active Comparator: Hands-on assistance group; During trainees' attempted cannulation, the trainer gave unlimited verbal instructions with hands-on assistance limited to only adjustment of scope position if necessary. To avoid unintended cannulation, the trainer was not allowed to touch the control section of the scope or the sphincterotome used for cannulation. However, the trainer would correct any inappropriate maneuvers immediately to avoid unnecessary papillary trauma and potential complications. The trainees could ask for help or stop cannulation at any time if they were not comfortable continuing the procedure. The trainer would then take over and continue with the cannulation.	Behavioral: The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of successful biliary cannulation	The percentage of trainee successfully biliary cannulation	10 minutes

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Collaborators: Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University; Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: December 27, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: KY20232429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No