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Cholangioscopic Classification of Bile Duct Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794987
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Instituto Ecuatoriano de Enfermedades Digestivas

Brief 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

Condition or disease Intervention/treatment
Bile Duct Lesions Device: SpyGlass® choledoscopy

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Study Type : Observational
Actual Enrollment : 130 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Proposal of a Macroscopic Classification for Tissular Lesions of the Bile Duct Detected During Per Oral Cholangioscopy (POCS)
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
Classification group
Group of endoscopists that will use the previous classification to select the bile duct tissular lesion images detected by SpyGlass® choledoscopy as benign or malignant with the different subtypes
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.

No classification group
Group of endoscopists that will classified the bile duct tissular lesion images detected by SpyGlass® choledoscopy as benign or malignant with the different subtypes without using the classification.
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.




Primary Outcome Measures :
  1. Evaluation of vascular and surface features of benign and malignant lesions detected by POCS images, that could be used to perform a macroscopic classification of bile duct tissular lesions [ Time Frame: 24 month ]
    Vascular and surface features were analyzed using POCS images of bile duct lesions and were correlated to histopathology and 6 month follows up. Finally a classification differenciating benign from malignant bile duct lesions, was performed.

  2. The accuracy, sensitivity, specificity, positive and negative predictive value of the macroscopic classification will be measure in order to perform a prospective validation of the classification. [ Time Frame: 12 month ]
    The images of bile duct lesions will be evaluated by two groups of endoscopists but only one will do it using the previously designed classification. Diagnostic accuracy, sensitivity, specificity, positive and negative predictive value will be measure and compared between groups.


Biospecimen Retention:   Samples Without DNA
Histological biopsies of tissular lesions of bile duct


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Stage 1: 63 patients enrolled with bile duct tissular lesion detected by POCS. Cholangioscopic lesions images (315) were compared to histopathology results and 6 months follow up with POCS, and an experienced endoscopist with more than 140 POCS performed a POCS macroscopic classification of tissular bile duct lesions, based on the morphological and vascular pattern.

Stage 2: estimated enrollment of 100 patients with bile duct tissular lesion detected by POCS. Patients included will be analyzed by two groups of endoscopists. One group (action group) will use the previous classification to select the images as benign or malignant with the different subtypes; and the second group (control group) will do it without using the classification.

Criteria

Inclusion Criteria:

  • Above 18 years old patients
  • Who agree to participate in the study
  • Patients with tissular biliary lesions detected by POCS

Exclusion Criteria:

  • Tissular lesions with no histology confirmation (either biopsy or surgical resection in case of malignancy suspicion) or 6 months follow-up by POCS (in case of benign suspicion)
  • Severe uncontrolled coagulopathy
  • Esophageal, gastric or duodenal stenosing tumors with no possibility of scope passage
  • Prior history of esophageal, gastric or surgery with no possibility of scope passage
  • Contrast allergy
  • Pregnancy and lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794987


Locations
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Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital
Guayaquil, Guayas, Ecuador, 090505
Sponsors and Collaborators
Instituto Ecuatoriano de Enfermedades Digestivas
Investigators
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Principal Investigator: Carlos A Robles-Medranda, MD Ecuadorian Institute of Digestive Diseases
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto Ecuatoriano de Enfermedades Digestivas
ClinicalTrials.gov Identifier: NCT02794987    
Other Study ID Numbers: MAY-1-2016
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Instituto Ecuatoriano de Enfermedades Digestivas:
Bile duct
indeterminate stricture
cholangioscopy
Spyglass