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Completed

NCT Number: NCT01851226

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

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.

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Key information

Conditions

Disease as Reason for ERCP

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hands-on ERCP training.

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Acronym: ERCP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 10, 2013
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.