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NCT04840537
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
NA trial testing endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP in Malignant Biliary Stenosis in 150 participants. Status unknown.
26 December 2018
Quick facts
| Lead sponsor | Frederic PRAT, MD, PhD |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 150 |
| Start date | 26 December 2018 |
| Primary completion | 26 December 2018 |
| Estimated completion | 26 December 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
Conditions studied
- Malignant Biliary Stenosis — all drugs for Malignant Biliary Stenosis →
Sponsor
Frederic PRAT, MD, PhD
Who can join
Adults 18 to 85, any sex, with Malignant Biliary Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting. The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness. The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT04840537
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Related trials
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 NCT04840537 (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 Frederic PRAT, MD, PhD
- Last refreshed: 12 April 2021
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/NCT04840537.
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