Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation

• ClinicalTrials.gov Identifier: NCT04609917
• Recruitment Status: Completed
• First Posted: October 30, 2020
• Last Update Posted: October 30, 2020
• Sponsor: Air Force Military Medical University, China
• Information provided by (Responsible Party): Yanglin Pan, Air Force Military Medical University, China

Study Description

Brief Summary:

Endoscopic Retrograde Cholangiopancreatography (ERCP) is one of the most technically challenging procedures in gastrointestinal endoscopy. Selective deep cannulation is a critical step for the performance of ERCP. The incidence of difficult cannulation has been reported in many studies, ranging from 10% to 40% in patients with native papilla. Difficult cannulation is an independent risk factor for post-ERCP pancreatitis (PEP).

The definition of difficult cannulation has been proposed by European Society of Gastrointestinal Endoscopy (ESGE) guidelines. Initial cannulation is considered difficult with the presence of one or more of the following: more than 5 min for attempting to cannulate; more than 5 contacts with the papilla; more than 1 unintended pancreatic duct cannulation or opacification. The clear definition of difficult cannulation is important for making decisions during or after ERCP, including determining the appropriate time to transfer to advanced cannulation techniques (e.g. early precut) and whether prophylactic methods should be administrated to reduce the risk of PEP. Although 5-5-1 criteria have been widely used during ERCP practice or in relevant studies, it remains unclear whether the current criteria are suitable for the cannulation procedure with trainee involvement. Because of inexperienced manipulation of the scope and accessories, the involvement of trainees generally increases the overall cannulation time and attempts, which are the two important parameters in the criteria of difficult cannulation. Thus, the investigators hypothesized that the definition of difficult cannulation in trainee-involved cannulation might be different from the traditional 5-5-1 criteria.

Condition or disease	Intervention/treatment
Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography	Procedure: trainee invlovement

Study Design

• Study Type: Observational
• Actual Enrollment: 4415 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Proposal of Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation Procedure
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 20, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
trainee group; Patients with native papilla who underwent selective biliary cannulation with trainee involvement	Procedure: trainee invlovement; Patients underwent selective biliary cannulation with trainee involvement
non-trainee group; Patients with native papilla who underwent selective biliary cannulation without trainee involvement

Outcome Measures

Primary Outcome Measures :

1. rates of difficult cannulation [ Time Frame: 2 hours ]
   The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile

Secondary Outcome Measures :

1. incidences of PEP [ Time Frame: 48 hours ]
2. overall adverse events [ Time Frame: 48 hours ]
3. the proportion of advanced cannulation methods [ Time Frame: 4 hours ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients with native papilla who underwent ERCP in Xijing Hospital in China

Criteria

Inclusion Criteria:

• patients with native papilla

Exclusion Criteria:

• indications of major or minor pancreatic duct (PD) cannulation; no attempts of cannulation due to inaccessible papilla; cannulation via the papillary fistula; patients with duodenal stenosis or anatomical deformity secondary to prior surgery.

Contacts and Locations

Locations

China, Shaanxi

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China, 710032

Sponsors and Collaborators

Air Force Military Medical University, China

More Information

Publications:

Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.

Ismail S, Udd M, Lindström O, Rainio M, Halttunen J, Kylänpää L. Criteria for difficult biliary cannulation: start to count. Eur J Gastroenterol Hepatol. 2019 Oct;31(10):1200-1205. doi: 10.1097/MEG.0000000000001515.

Halttunen J, Meisner S, Aabakken L, Arnelo U, Grönroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Löhr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.

• Responsible Party: Yanglin Pan, Associate Professor, Air Force Military Medical University, China
• ClinicalTrials.gov Identifier: NCT04609917
• Other Study ID Numbers: KY20201021-2
• First Posted: October 30, 2020
• Last Update Posted: October 30, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanglin Pan, Air Force Military Medical University, China:

ERCP; Difficult cannulation; Trainee; PEP