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NCT05374122
AI Guidance for Biopsy in Suspected Cholangiocarcinoma
NA trial testing DSOC with AI biopsy guidance in Neoplasms in 48 participants. Status unknown.
30 December 2023
Quick facts
| Lead sponsor | Instituto Ecuatoriano de Enfermedades Digestivas |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 48 |
| Start date | 1 May 2022 |
| Primary completion | 30 December 2023 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across Ecuador |
Drugs / interventions tested
- DSOC with AI biopsy guidance
- DSOC biopsy without AI guidance
Conditions studied
- Neoplasms — all drugs for Neoplasms →
- Non-Neoplastic — all drugs for Non-Neoplastic →
- Bile Duct Neoplasms — all drugs for Bile Duct Neoplasms →
- Bile Duct Lesions — all drugs for Bile Duct Lesions →
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas — full company profile →
Who can join
Adults 18 to 99, any sex, with Neoplasms or Non-Neoplastic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Digital single-operator cholangioscopy (DSOC) has emerged as a medical advance with an important role in the evaluation of indeterminate biliary lesions. This technique has demonstrated higher sensitivity in the guidance for tissue acquisition when compared with standard endoscopic retrograde cholangiopancreatography (ERCP). DSOC-guided biopsy is considered technically safe and successful for tissue collection. Hand in hand with the development of more precise diagnostic techniques, comes the implementation of artificial intelligence (AI) for diagnostic assessment. For the past decade, the role of artificial intelligence (AI) has been increasing at a rapid pace. In the biliary tract, different models have been proposed for the characterization of malignant features. Nevertheless, to date, the discrepancy between the visual impression of the operator and the histological results obtained by cholangioscopy still present, affecting the accuracy the diagnosis. Based on the above, the investigators aim to assess the diagnostic accuracy of AI for the guidance of tissue acquisition with DSOC compared to DSOC without AI for suspected cholangiocarcinoma. As a secondary aim, the investigators pursue to compare quality of AI-guided biopsies samples vs. DSOC biopsies without AI.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Understanding Liver and Digestive Diseases: A Paved Road to Improve Diagnosis, Management, and Treatment.
Bergheim I, Cadranel JF, Chen JG, Ding WX, et al · · 2026 · PMID 41953857 · DOI 10.37349/edd.2026.1005110
Verify or expand the search:
- PubMed search for NCT05374122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- 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 NCT05374122 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Ecuatoriano de Enfermedades Digestivas
- Last refreshed: 6 March 2023
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/NCT05374122.
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