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

Disease as Reason for ERCP Clinical Trial

— ERCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851226
• Other study ID #: 20130415-3
• Status: Completed
• Phase: N/A
• First received: May 4, 2013
• Last updated: April 1, 2014
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease as Reason for ERCP

Intervention

Procedure:
• Hands-on ERCP training.
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.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of selective cannulation by trainee	The rate of successful selective cannulation by trainee in one year.	up to one year	No
Secondary	Complication rate	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);	up to one year	Yes
Secondary	Performance score of selective cannulation by trainees	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.	up to one year	No
Secondary	Difficulty score of cannulation	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.	up to one year	No
Secondary	Final success rate of cannulation		up to one year	No
Secondary	Total time of successful cannulation		up to one year	No
Secondary	Rate of Needle-knife precut sphincterotomy		up to one year	No