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NCT03698266

Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?

Completed NA Last updated 3 April 2024
What this trial tests

NA trial testing Needle knife fistulotomy in ERCP in 84 participants. Completed in 30 January 2020.

Timeline
23 November 2018
Primary endpoint
29 January 2020
30 January 2020

Quick facts

Lead sponsorLawrence Charles Hookey
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment84
Start date23 November 2018
Primary completion29 January 2020
Estimated completion30 January 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Lawrence Charles Hookey

Who can join

18 and older, any sex, with ERCP or Biliary Disease Tract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts. Patients will consent to allow the study physician to access these areas of the digestive system by making a cut using a technique called a needle-knife fistulotomy. If the physician is unable to gain access through this method, they will make the cut using a technique called a sphincterotomy.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Fistulotomy-First Approach is Safe and Effective in Endoscopic Retrograde Cholangiography: Results of a Prospective Case Series.
    Hnaris K, Taylor C, Hookey L, Bechara R. · · 2021 · cited 6× · PMID 34337317 · DOI 10.1093/jcag/gwaa025
  2. A270 AMPULLARY MORPHOLOGY PREDICTS SUCCESS AND POST-PROCEDURE COMPLICATIONS IN PRIMARY NEEDLE-KNIFE FISTULOTOMY FOR BILIARY CANNULATION IN ERCP: RESULTS OF A PROSPECTIVE CASE SERIES
    Hew S, Taylor C, Hookey L, Bechara R. · · 2020

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Other trials of Needle knife fistulotomy

Trials testing the same drug.

Other recruiting trials for ERCP

Currently open trials in the same condition.

Other Lawrence Charles Hookey trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03698266.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing