Guidewire Management in ERCP

NCT05219123 | Completed

• 1 other identifier: REB21-0940
• Study Type: observational
• Target: 7,461
• Locations: 1 country
• Sites: 1

Brief Summary

Intra-procedural guidewire management is a parameter whose impact remains incompletely understood in terms of its association with post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Inadvertent guidewire cannulation of the pancreatic duct (PD) when attempting common bile duct (CBD) cannulation is recognized as a risk factor for PEP. However, to date, no studies have assessed whether a single PD wire cannulation is associated with a higher PEP risk compared to no PD cannulations. Similarly, the relationship between each additional PD cannulation and the incremental magnitude of PEP risk remains unclear. In this study, the investigators will aim to assess whether a single inadvertent PD cannulation (versus no PD cannulation) is associated with an increased risk of PEP (the primary outcome).

Conditions

ERCP

Outcome Measures

Primary Outcomes (1)

• post-ERCP pancreatitis

  Defined using a previously published set of a priori criteria by indication (Cotton et al. Gastrointest Endoscopy 2010; 71:446-54).

  30 days

Study Arms (2)

No PD cannulation

Patients with native papilla undergoing ERCP for biliary indications with no inadvertent pancreatic duct cannulation

Other: ERCP with no PD cannulation

Single PD cannulation

Patients with native papilla undergoing ERCP for biliary indications with a single inadvertent pancreatic duct cannulation with a guide wire

Other: ERCP with single PD cannulation

Interventions

ERCP with no PD cannulation OTHER

ERCP with no PD cannulation

No PD cannulation

ERCP with single PD cannulation OTHER

ERCP with single PD cannulation

Single PD cannulation

Eligibility Criteria

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

Study Population

Patients referred to a hospital-based endoscopy unit for ERCP who have a native major papilla.

You may qualify if:

• Subject referred for ERCP, regardless of indication;
• Subject age 18 years or older;
• Subject able to give informed consent to involvement be included.

You may not qualify if:

• Previous sphincterotomy or sphincteroplasty
• Subject has a standard contraindication to ERCP;
• Subject or surrogate unable or unwilling to provide informed consent;
• Subject age \< 18 years.

Sponsors & Collaborators

• University of Calgary: lead
• McGill University: collaborator
• University of Ottawa: collaborator
• Queen's University: collaborator
• Halton Health (Oakville): collaborator
• Island Health, Victoria, BC: collaborator

Study Sites (1)

Peter Lougheed Hospital

Calgary, Alberta, Canada

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nauzer Forbes, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 1, 2022
• Study Start: December 20, 2021
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 20, 2024

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)