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

NCT01851226 | Completed DMC

• 1 other identifier: 20130415-3
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Disease as Reason for ERCP

Outcome Measures

Primary Outcomes (1)

• Success rate of selective cannulation by trainee

  The rate of successful selective cannulation by trainee in one year.

  up to one year

Secondary Outcomes (6)

• Complication rate

  up to one year

• Performance score of selective cannulation by trainees

  up to one year

• Difficulty score of cannulation

  up to one year

• Final success rate of cannulation

  up to one year

• Total time of successful cannulation

  up to one year

Study Arms (3)

5 minutes group

EXPERIMENTAL

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.

10 minutes group

EXPERIMENTAL

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.

15 minutes group

EXPERIMENTAL

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.

Interventions

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.

10 minutes group; 15 minutes group; 5 minutes group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (8)

• Swan MP, Alexander S, Moss A, Williams SJ, Ruppin D, Hope R, Bourke MJ. Needle knife sphincterotomy does not increase the risk of pancreatitis in patients with difficult biliary cannulation. Clin Gastroenterol Hepatol. 2013 Apr;11(4):430-436.e1. doi: 10.1016/j.cgh.2012.12.017. Epub 2013 Jan 11.

  PMID: 23313840 BACKGROUND

• Nambu T, Ukita T, Shigoka H, Omuta S, Maetani I. Wire-guided selective cannulation of the bile duct with a sphincterotome: a prospective randomized comparative study with the standard method. Scand J Gastroenterol. 2011 Jan;46(1):109-15. doi: 10.3109/00365521.2010.521889. Epub 2010 Oct 6.

  PMID: 20923377 BACKGROUND

• Tringali A, Mutignani M, Milano A, Perri V, Costamagna G. No difference between supine and prone position for ERCP in conscious sedated patients: a prospective randomized study. Endoscopy. 2008 Feb;40(2):93-7. doi: 10.1055/s-2007-995317. Epub 2007 Dec 5.

  PMID: 18058651 BACKGROUND

• Testoni PA, Mariani A, Giussani A, Vailati C, Masci E, Macarri G, Ghezzo L, Familiari L, Giardullo N, Mutignani M, Lombardi G, Talamini G, Spadaccini A, Briglia R, Piazzi L; SEIFRED Group. Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study. Am J Gastroenterol. 2010 Aug;105(8):1753-61. doi: 10.1038/ajg.2010.136. Epub 2010 Apr 6.

  PMID: 20372116 BACKGROUND

• Sutton VR, Hong MK, Thomas PR. Using the 4-hour Post-ERCP amylase level to predict post-ERCP pancreatitis. JOP. 2011 Jul 8;12(4):372-6.

  PMID: 21737899 BACKGROUND

• Mariani A, Giussani A, Di Leo M, Testoni S, Testoni PA. Guidewire biliary cannulation does not reduce post-ERCP pancreatitis compared with the contrast injection technique in low-risk and high-risk patients. Gastrointest Endosc. 2012 Feb;75(2):339-46. doi: 10.1016/j.gie.2011.09.002. Epub 2011 Nov 9.

  PMID: 22075192 BACKGROUND

• Kobayashi G, Fujita N, Imaizumi K, Irisawa A, Suzuki M, Murakami A, Oana S, Makino N, Komatsuda T, Yoneyama K. Wire-guided biliary cannulation technique does not reduce the risk of post-ERCP pancreatitis: multicenter randomized controlled trial. Dig Endosc. 2013 May;25(3):295-302. doi: 10.1111/j.1443-1661.2012.01372.x. Epub 2012 Sep 19.

  PMID: 23368891 BACKGROUND

• Pan Y, Zhao L, Leung J, Zhang R, Luo H, Wang X, Liu Z, Wan B, Tao Q, Yao S, Hui N, Fan D, Wu K, Guo X. Appropriate time for selective biliary cannulation by trainees during ERCP--a randomized trial. Endoscopy. 2015 Aug;47(8):688-95. doi: 10.1055/s-0034-1391564. Epub 2015 Mar 6.

  PMID: 25750038 DERIVED

Study Officials

• Yanglin Pan, M.D.

  Associated professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: May 4, 2013
• First Posted: May 10, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 2, 2014

Record last verified: 2014-04

Locations

CN (1)