Clinical trial NCT01851226: Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease as Reason for ERCP
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Success rate of selective cannulation by trainee
timeFrame: up to one year
Secondary outcomes:
measure: Complication rate
timeFrame: up to one year
measure: Performance score of selective cannulation by trainees
timeFrame: up to one year
measure: Difficulty score of cannulation
timeFrame: up to one year
measure: Final success rate of cannulation
timeFrame: up to one year
measure: Total time of successful cannulation
timeFrame: up to one year
measure: Rate of Needle-knife precut sphincterotomy
timeFrame: up to one year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
affiliation: Associated professor
name: Yanglin Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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