Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
- Conditions
- Disease as Reason for ERCP
- Interventions
- Procedure: Hands-on ERCP training.
- Registration Number
- NCT01851226
- Lead Sponsor
- Air Force Military Medical University, China
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- Age 18-90 years old;
- Without prior EST.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5 minutes group Hands-on ERCP training. 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. 10 minutes group Hands-on ERCP training. 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. 15 minutes group Hands-on ERCP training. 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.
- Primary Outcome Measures
Name Time Method Success rate of selective cannulation by trainee up to one year The rate of successful selective cannulation by trainee in one year.
- Secondary Outcome Measures
Name Time Method Complication rate 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);
Performance score of selective cannulation by trainees 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.
Difficulty score of cannulation 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.
Final success rate of cannulation up to one year Total time of successful cannulation up to one year Rate of Needle-knife precut sphincterotomy up to one year
Trial Locations
- Locations (1)
Endoscopic center, Xijing Hospital of Digestive Diseases
🇨🇳Xi'an, Shaanxi, China