Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249400
• Other study ID #: KY20201005-2
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Pancreatic Diseases

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