Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05147389 · ClinicalTrials.gov registry record
Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis
A clinical trial of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas.
- Completed
- Registry status
- 170
- Enrollment target
- 6
- Study locations
NCT05147389: Completed study of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas.
NCT05147389 is a study of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder that has completed, run by Instituto Ecuatoriano de Enfermedades Digestivas. The registered enrollment target is 170 participants. The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147389, a study of Common Bile Duct Neoplasms and Non-Neoplastic Bile Duct Disorder, has completed, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas.
- COMPLETED
- Registry status
- 170 participants
- Enrollment target
- 6
- Study locations
Study Summary
Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artificial intelligence (AI) tools is almost exclusively for intrahepatic CCA (iCCA). Therefore, more AI tools are necessary for assessing extrahepatic neoplastic bile duct lesions. In Ecuador, the investigators have recently proposed an AI model to classify bile duct lesions during real-time DSOC, which accurately detected malignancy patterns. This research pursues a clinical validation of our AI model for distinguishing between neoplastic and non-neoplastic bile duct lesions, compared with high DSOC experienced endoscopists.
Primary Outcome
Cases will be first followed up during one year to confirm or discard neoplastic bile duct lesions. A definite diagnosis of neoplastic bile duct lesion will be based on DSOC-guided biopsy specimen or findings from further indicated procedures, including brush cytology fluoroscopy-guided, endoscopic ultrasound-guided tissue sampling, surgical samples, and even imaging test in the context of a more impaired patient. Finally, the agreement between one-year follow-up (gold standard) vs. AI model and
Conditions Studied
Interventions
- DIAGNOSTIC_TEST AI model classification
- DIAGNOSTIC_TEST DSOC endoscopist experts' classification
Study Locations (6)
Texas
- Baylor Saint Luke's Medical Center - Houston
- Houston Methodist Hospital - Houston
Other
- Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel (UZB)/Vrije Universiteit Brussel (VUB) - Brussels
- Serviço de Endoscopía Gastrointestinal do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo
New Jersey
- Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University - New Brunswick
Guayas
- Carlos Robles-Medranda - Guayaquil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2022-05-01 |
What the finished NCT05147389 record still lists
NCT05147389 is an observational study that tracks outcomes without assigning an intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Common Bile Duct Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which AI model classification is the first listed.
NCT05147389 lists 6 locations in 4 states (Texas, Other, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05147389 about?
NCT05147389 is a clinical study titled "Artificial Intelligence for Digital Cholangioscopy Neoplasia Diagnosis". Digital single-operator cholangioscopy (DSOC) findings achieve high diagnostic accuracy for neoplastic bile duct lesions. To date, there is not a universally accepted DSOC classification. Endoscopists' Intra and interobserver agreements vary widely. Cholangiocarcinoma (CCA) assessment through artifi...
What is the current status of trial NCT05147389?
This trial is currently completed. The enrollment target is 170 participants. The study started on 2020-10-01. Estimated completion is 2022-05-01.
What conditions does trial NCT05147389 study?
This clinical trial studies the following conditions: Common Bile Duct Neoplasms, Non-Neoplastic Bile Duct Disorder.
What interventions are being tested in trial NCT05147389?
The interventions under investigation include: AI model classification (DIAGNOSTIC_TEST), DSOC endoscopist experts' classification (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05147389?
This trial is sponsored by Instituto Ecuatoriano de Enfermedades Digestivas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05147389 being conducted?
This trial has 6 study locations across New Jersey, Texas, Guayas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02016430 · 170 participants · NA
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)
- NCT02621021 · 170 participants · Phase 2
A Phase 2 Trial for Metastatic Melanoma Using Adoptive Cell Therapy With Tumor Infiltrating Lymphocytes Plus IL-2 Either Alone or Following the Administration of Pembrolizumab
- NCT04094701 · 170 participants · NA
Hip Arthroscopy Postoperative Opioid Demands
- NCT04166409 · 170 participants · Phase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI