Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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 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. |
Procedure: Off-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.
|
| No Intervention: On-site assistance group 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. |
Outcome Measures
Primary Outcome Measures
- Success rate of selective cannulation by trainee [up to one year]
The rate of successful selective cannulation by trainee during the training period.
Secondary Outcome Measures
- 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
- Final success rate of cannulation [up to one year]
- Total time of successful cannulation [up to one year]
- Radiation exposure time [up to one year]
Radiation exposure time for trainee and trainer
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-90 years old
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With native papilla
Exclusion Criteria:
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History of partial or total gastrectomy (Billroth I/II, Roux-en-Y)
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Type II duodenal stenosis
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Previously failed cannulation
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Chronic pancreatitis with stones in the pancreatic head
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Hemodynamic instability
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Lactating or pregnant women
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Inability to give written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Air Force Military Medical University, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Brinne Roos J, Bergenzaun P, Groth K, Lundell L, Arnelo U. Telepresence-teleguidance to facilitate training and quality assurance in ERCP: a health economic modeling approach. Endosc Int Open. 2020 Mar;8(3):E326-E337. doi: 10.1055/a-1068-9153. Epub 2020 Feb 21.
- Påhlsson HI, Groth K, Permert J, Swahn F, Löhr M, Enochsson L, Lundell L, Arnelo U. Telemedicine: an important aid to perform high-quality endoscopic retrograde cholangiopancreatography in low-volume centers. Endoscopy. 2013;45(5):357-61. doi: 10.1055/s-0032-1326269. Epub 2013 Mar 6.
- Pan Y, Zhao L, Leung J, Zhang R, Luo H, Wang X, Liu Z, Wan B, Tao Q, Yao S, Hui N, Fan D, Wu K, Guo X. Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial. Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6.
- Shimizu S, Itaba S, Yada S, Takahata S, Nakashima N, Okamura K, Rerknimitr R, Akaraviputh T, Lu X, Tanaka M. Significance of telemedicine for video image transmission of endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography procedures. J Hepatobiliary Pancreat Sci. 2011 May;18(3):366-74. doi: 10.1007/s00534-010-0351-8. Review.
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