Difficult Cannulation Criteria in Trainee Involved ERCP Cannulation

NCT04609917 | Completed

• 1 other identifier: KY20201021-2
• Study Type: observational
• Target: 4,415
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP; Difficult cannulation; Trainee; PEP

Outcome Measures

Primary Outcomes (1)

• rates of difficult cannulation

  The proportion of the participants with cannulation-related parameters (cannulation time, cannulation attempts, or inadvertent PD cannulation) above the 75% percentile

  2 hours

Secondary Outcomes (3)

• incidences of PEP

  48 hours

• overall adverse events

  48 hours

• the proportion of advanced cannulation methods

  4 hours

Study Arms (2)

trainee group

Patients with native papilla who underwent selective biliary cannulation with trainee involvement

Procedure: trainee invlovement

non-trainee group

Patients with native papilla who underwent selective biliary cannulation without trainee involvement

Interventions

trainee invlovement PROCEDURE

Patients underwent selective biliary cannulation with trainee involvement

trainee group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• patients with native papilla

You may not qualify if:

• 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.

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 (3)

• 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.

  PMID: 31863440 BACKGROUND

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

  PMID: 31464778 BACKGROUND

• Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr 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.

  PMID: 24628493 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: October 30, 2020
• Study Start: March 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 20, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

CN (1)