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NCT06694038
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
Phase 1, PHASE2 trial testing Needle Knife Fistulotomy in Biliary Obstruction Due to Common Bile Duct Stone in 186 participants. Completed in 1 July 2021.
25 June 2021
Quick facts
| Lead sponsor | Thomas Jefferson University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 186 |
| Start date | 31 January 2019 |
| Primary completion | 25 June 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Needle Knife Fistulotomy
- standard biliary cannulation
Conditions studied
- Biliary Obstruction Due to Common Bile Duct Stone — all drugs for Biliary Obstruction Due to Common Bile Duct Stone →
- Malignant Bile Duct Obstruction — all drugs for Malignant Bile Duct Obstruction →
Sponsor
Thomas Jefferson University
Who can join
18 and older, any sex, with Biliary Obstruction Due to Common Bile Duct Stone or Malignant Bile Duct Obstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06694038
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06694038 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
- Last refreshed: 19 November 2024
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/NCT06694038.
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