Pancreatic Diseases Clinical Trial
Official title:
Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Endoscopic center, Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Air Force Military Medical University, China |
China,
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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
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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