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

Primary Purpose

ERCP Training, Biliary Tract Diseases, Pancreatic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Off-site assistance
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ERCP Training

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Endoscopic center, Xijing Hospital of Digestive DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Off-site assistance group

On-site assistance group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Success rate of selective cannulation by trainee
The rate of successful selective cannulation by trainee during the training period.

Secondary Outcome Measures

Complication rate
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
The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better
Final success rate of cannulation
The overall rate of successful selective cannulation by trainee and trainer
Total time of successful cannulation
Total time required for successful cannulation
Radiation exposure time
Radiation exposure time for trainee and trainer

Full Information

First Posted
February 10, 2022
Last Updated
May 28, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05249400
Brief Title
Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training
Official Title
Effect of Off-site Assistance on Success Rate of Selective Cannulation During Hands-on ERCP Training: A Randomized Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERCP Training, Biliary Tract Diseases, Pancreatic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Off-site assistance group
Arm Type
Experimental
Arm Description
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.
Arm Title
On-site assistance group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Off-site assistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate of selective cannulation by trainee
Description
The rate of successful selective cannulation by trainee during the training period.
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Complication rate
Description
Post-ERCP pancreatitis (mild, moderate-to-severe); Hyperamylasemia; Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery); Bleeding (mild, moderate, severe);
Time Frame
up to one year
Title
Performance score of selective cannulation
Description
The trainee's performance score of cannulation by trainer and performance video. Out of 5 points, higher scores are better
Time Frame
up to one year
Title
Final success rate of cannulation
Description
The overall rate of successful selective cannulation by trainee and trainer
Time Frame
up to one year
Title
Total time of successful cannulation
Description
Total time required for successful cannulation
Time Frame
up to one year
Title
Radiation exposure time
Description
Radiation exposure time for trainee and trainer
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanglin Pan, M.D.
Phone
86-20-84771536
Email
yanglinpan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Luo, M.D.
Phone
86-20-84771536
Email
fmmulh@163.com
Facility Information:
Facility Name
Endoscopic center, Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, M.D.
Phone
86-29-84771536
Email
panyanglin@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25750038
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.
Results Reference
background
PubMed Identifier
30738985
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.
Results Reference
background
PubMed Identifier
23468194
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.
Results Reference
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PubMed Identifier
32118106
Citation
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.
Results Reference
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PubMed Identifier
21127912
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.
Results Reference
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Effect of Off-site Assistance on Success Rate of Selective Cannulation During hands-on ERCP Training

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