Comparison of Off-site vs. hands-on Assistance for Trainees During ERCP
1 other identifier
interventional
754
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 3, 2020
CompletedFirst Submitted
Initial submission to the registry
December 27, 2023
CompletedFirst Posted
Study publicly available on registry
January 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJanuary 17, 2024
January 1, 2024
3.5 years
December 27, 2023
January 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rates of successful biliary cannulation
The percentage of trainee successfully biliary cannulation
10 minutes
Secondary Outcomes (4)
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
Study Arms (2)
Off-site assistance group
EXPERIMENTALThe 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.
Hands-on assistance group
ACTIVE COMPARATORDuring 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.
Interventions
The senior trainer guides the trainees during ERCP procedure outside the operating room using communication equipment and the screen displaying an endoscopic view.
Eligibility Criteria
You may qualify if:
- Patients aged 18-90 years who received ERCP
- Patients with native papilla
You may not qualify if:
- Patients with altered anatomy (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Department of Gastroenterology, The Second Affiliated Hospital Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
Department of Endoscopy, Eastern Hepatobiliary Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 201823, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 27, 2023
First Posted
January 9, 2024
Study Start
December 3, 2020
Primary Completion
June 1, 2024
Study Completion
August 1, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share