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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05249400
Other study ID # KY20201005-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date December 2023

Study information

Verified date May 2023
Source Air Force Military Medical University, China
Contact Yanglin Pan, M.D.
Phone 86-20-84771536
Email yanglinpan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Endoscopic center, Xijing Hospital of Digestive Diseases Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Pahlsson HI, Groth K, Permert J, Swahn F, Lohr 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. — View Citation

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. — View Citation

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. — View Citation

Wani S, Han S, Simon V, Hall M, Early D, Aagaard E, Abidi WM, Banerjee S, Baron TH, Bartel M, Bowman E, Brauer BC, Buscaglia JM, Carlin L, Chak A, Chatrath H, Choudhary A, Confer B, Cote GA, Das KK, DiMaio CJ, Dries AM, Edmundowicz SA, El Chafic AH, El Hajj I, Ellert S, Ferreira J, Gamboa A, Gan IS, Gangarosa L, Gannavarapu B, Gordon SR, Guda NM, Hammad HT, Harris C, Jalaj S, Jowell P, Kenshil S, Klapman J, Kochman ML, Komanduri S, Lang G, Lee LS, Loren DE, Lukens FJ, Mullady D, Muthusamy RV, Nett AS, Olyaee MS, Pakseresht K, Perera P, Pfau P, Piraka C, Poneros JM, Rastogi A, Razzak A, Riff B, Saligram S, Scheiman JM, Schuster I, Shah RJ, Sharma R, Spaete JP, Singh A, Sohail M, Sreenarasimhaiah J, Stevens T, Tabibian JH, Tzimas D, Uppal DS, Urayama S, Vitterbo D, Wang AY, Wassef W, Yachimski P, Zepeda-Gomez S, Zuchelli T, Keswani RN. Setting minimum standards for training in EUS and ERCP: results from a prospective multicenter study evaluating learning curves and competence among advanced endoscopy trainees. Gastrointest Endosc. 2019 Jun;89(6):1160-1168.e9. doi: 10.1016/j.gie.2019.01.030. Epub 2019 Feb 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success rate of selective cannulation by trainee The rate of successful selective cannulation by trainee during the training period. up to one year
Secondary Complication rate Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery); Bleeding (mild, moderate, severe); up to one year
Secondary Performance score of selective cannulation The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better up to one year
Secondary Final success rate of cannulation The overall rate of successful selective cannulation by trainee and trainer up to one year
Secondary Total time of successful cannulation Total time required for successful cannulation up to one year
Secondary Radiation exposure time Radiation exposure time for trainee and trainer up to one year
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