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Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training (ERCP)

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ClinicalTrials.gov Identifier: NCT01851226
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Fourth Military Medical University

Brief Summary:

Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform enough cases to grasp this technique. The methods of ERCP training include hands-on teaching, training on different kinds of simulators, training on ex-vivo or live anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.

Selective cannulation is considered the most difficult and challenging part of learning ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP training. The time used for attempting cannulation by trainees was 5min or 10min in several centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major complication related to cannulation, was 4.0%, which was comparable with previous studies.

The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation would increase success rate of selective cannulation and help to improve skills more quickly. At the meantime, with actively verbal or hands-on assistance from the instructor during performance of trainees, the risk of complications would not increased with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study was designed to evaluate the effects of different periods of time for trainees to attempt selective cannulation on success rate of cannulation, self-satisfaction of performance and post-ERCP pancreatitis.


Condition or disease Intervention/treatment Phase
Disease as Reason for ERCP Procedure: Hands-on ERCP training. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
Study Start Date : May 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: 5 minutes group
The time limit of attempt selective cannulation by trainees is limited to 5 minutes. If the trainees failed to enter the targeted duct within 5 minutes, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.
Procedure: Hands-on ERCP training.
The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of common bile duct (CBD) or pancreatic duct (PD). During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within the designated length of time, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation. The whole procedure of cannulation was recorded by video. Rectal indomethacin and/or pancreatic stent was used in high-risky patients.

Experimental: 10 minutes group
The time limit of attempt selective cannulation by trainees is limited to 10 minutes. If the trainees failed to enter the targeted duct within 10 minutes, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.
Procedure: Hands-on ERCP training.
The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of common bile duct (CBD) or pancreatic duct (PD). During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within the designated length of time, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation. The whole procedure of cannulation was recorded by video. Rectal indomethacin and/or pancreatic stent was used in high-risky patients.

Experimental: 15 minutes group
The time limit of attempt selective cannulation by trainees is limited to 15 minutes. If the trainees failed to enter the targeted duct within 15 minutes, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.
Procedure: Hands-on ERCP training.
The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of common bile duct (CBD) or pancreatic duct (PD). During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within the designated length of time, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation. The whole procedure of cannulation was recorded by video. Rectal indomethacin and/or pancreatic stent was used in high-risky patients.




Primary Outcome Measures :
  1. Success rate of selective cannulation by trainee [ Time Frame: up to one year ]
    The rate of successful selective cannulation by trainee in one year.


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: up to one year ]
    Post-ERCP pancreatitis (mild, moderate-to-severe); Abdominal pain (mild, moderate, severe); Hyperamylasemia; Vomiting (mild, moderate, severe); Cholangitis (mild, moderate, severe); Perforation (conservative therapy, surgery); Bleeding (mild, moderate, severe);

  2. Performance score of selective cannulation by trainees [ Time Frame: up to one year ]
    How much will you score on your performance of cannulation? ----for trainee: 0-terrible, 10-perfect; How much will you score on the performance of cannulation by trainee? --for instructor: 0-terrible, 10-perfect.

  3. Difficulty score of cannulation [ Time Frame: up to one year ]
    How much will you score on the difficulty of the cannulation? -----for trainee: 0-very easy, 10-very difficult; How much will you score on the difficulty of the cannulation? -----for instructor: 0-very easy, 10-very difficult.

  4. Final success rate of cannulation [ Time Frame: up to one year ]
  5. Total time of successful cannulation [ Time Frame: up to one year ]
  6. Rate of Needle-knife precut sphincterotomy [ Time Frame: up to one year ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-90 years old;
  • Without prior EST.

Exclusion Criteria:

  • History of partial or total gastrectomy (Billroth I/II, Roux-en-Y);
  • Duodenal stricture (benign or malignant);
  • Ampullary carcinoma;
  • Previously failed selective cannulation;
  • Chronic pancreatitis with PD stone;
  • Minor papilla cannulation;
  • Papilla fistula;
  • Severe diseases of heart, lung, brain and kidney;
  • Hemodynamical unstability;
  • Pregnant women;
  • Refusal or unable to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851226


Locations
China, Shaanxi
Endoscopic center, Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Fourth Military Medical University
Investigators
Principal Investigator: Yanglin Pan, M.D. Associated professor

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanglin Pan, Associated professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01851226     History of Changes
Other Study ID Numbers: 20130415-3
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014