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

Air Force Military Medical University of People's Liberation Army

Status: Completed

Conditions: Disease as Reason for ERCP

Treatments: Procedure: Hands-on ERCP training.

Study type: Interventional

Funder types: Other

Identifiers

NCT01851226

20130415-3

Details and patient eligibility

About

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.

Enrollment: 256 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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256 participants in 3 patient groups

5 minutes group

Experimental group

Description:

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.

Treatment:

Procedure: Hands-on ERCP training.

10 minutes group

Experimental group

Description:

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.

Treatment:

Procedure: Hands-on ERCP training.

15 minutes group

Experimental group

Description:

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.

Treatment:

Procedure: Hands-on ERCP training.