Last reviewed · How we verify

NCT02916199

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Completed NA Last updated 30 January 2019
What this trial tests

NA trial testing cannulation of ampulla of Vater in Common Bile Duct Stone in 207 participants. Completed in 28 November 2017.

Timeline
4 October 2016
Primary endpoint
28 November 2017
28 November 2017

Quick facts

Lead sponsorGangnam Severance Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment207
Start date4 October 2016
Primary completion28 November 2017
Estimated completion28 November 2017
Sites7 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Gangnam Severance Hospital

Who can join

Adults 19 to 90, any sex, with Common Bile Duct Stone or Malignant Hepatobiliary Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional cannulation methods.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.
    Jang SI, Kim DU, Cho JH, Jeong S, et al · · 2020 · cited 34× · PMID 31913191 · DOI 10.14309/ajg.0000000000000480

Verify or expand the search:

Other recruiting trials for Common Bile Duct Stone

Currently open trials in the same condition.

Other Gangnam Severance Hospital 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/NCT02916199.

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