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Cholangioscopic Classification of Bile Duct Lesions

NCT02794987 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2016-12-21

No results posted yet for this study

Summary

Endoscopic retrograde cholangio-pancreatography (ERCP) is a diagnostic and therapeutic procedure, however it has an important image limitation. The fluoroscopic cholangiography shows the biliary tree in a two-dimensional view. When an indeterminate biliary stricture is seen, the certainly diagnosis by ERCP depends on a blind biopsy sampling with the risk of missed pathology and sampling errors. SpyGlass® System (Boston Scientific, Marlborough, Massachusetts, USA) is a cholangioscope that enables single-operator, direct visualization of the pancreatico-biliary system and the evaluation of intraductal lesions. It has a digital sensor with 4x resolution and a 1.2 mm working channel that allows the passage of the SpyBite® Forceps biopsy. It has been demonstrated that the use of SpyGlass® System and SpyBite® Forceps changes clinical management in 64% of patients. It has a sensitivity of 76.5% for indeterminate stricture diagnosis, compared to 29.4% and 5.9% sensitivity using blind biopsy brushing catheter respectively. Although it has been described before cholangioscopic images of malignant biliary lesions like an irregular lesion surface with irregular vessels and bleeding or a smooth surface without vessels for benign lesions, there is no current validated classification that allows unify the diagnostic criteria.

Methods: Study design: The study was design to be performed in 2 stages. Stage 1: observational, retrospective study with case collection from September 2013 to September 2015. Patients included had bile duct tissular lesion detected by POCS. The images were correlated to histopathology and 6 month follows up and a classification was finally performed to differentiate benign forma malignant bile duct lesions. Stage 2: patients with bile duct tissular lesion detected by POCS, will be the evaluated in a prospective, non-randomized and double blind manner. Two groups of endoscopist will evaluate the images but only one group will do it using the classification previously performed. Second stage case collection has already started (December 2015) and will include patients until December 2016.

* Endpoint Classification: Efficacy
* Intervention Model: Non interventional
* Primary Purpose: Diagnosis

Conditions

  • Bile Duct Lesions

Interventions

DEVICE

SpyGlass® choledoscopy

Stage 1: patients included were evaluated using a standard duodenoscope and both SpyGlass® cholangioscopes: First generation, SpyGlass® Direct Visualization System and Second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA) Procedures were performed by one experienced endoscopists with more than 300 ERCP/year (C.R.M). Biopsies were taken in order to correlate to histopathology. Stage 2: patients will be evaluated using a standard duodenoscope and second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA). Procedures will be performed by two experienced endoscopists with more than 300 ERCP/year (C.R.M and M.S.A). Biopsies will be taken in order to correlate to histopathology.

Sponsors & Collaborators

  • Instituto Ecuatoriano de Enfermedades Digestivas

    lead OTHER

Principal Investigators

  • Carlos A Robles-Medranda, MD · Ecuadorian Institute of Digestive Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Ecuador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02794987 on ClinicalTrials.gov