Cholangioscopic Classification of Bile Duct Lesions

NCT02794987 | Completed DMC

• 1 other identifier: MAY-1-2016
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

Bile Duct Lesions

Keywords

Bile duct; indeterminate stricture; cholangioscopy; Spyglass

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  24 month

• 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.

  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.

  12 month

Study Arms (2)

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

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

Interventions

SpyGlass® choledoscopy DEVICE

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.

Classification group; No classification group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital

Guayaquil, Guayas, 090505, Ecuador

Location

Related Publications (6)

• Seelhoff A, Schumacher B, Neuhaus H. Single operator peroral cholangioscopic guided therapy of bile duct stones. J Hepatobiliary Pancreat Sci. 2011 May;18(3):346-9. doi: 10.1007/s00534-010-0360-7.

  PMID: 21480000 BACKGROUND

• Tieu AH, Kumbhari V, Jakhete N, Onyimba F, Patel Y, Shin EJ, Li Z. Diagnostic and therapeutic utility of SpyGlass((R)) peroral cholangioscopy in intraductal biliary disease: single-center, retrospective, cohort study. Dig Endosc. 2015 May;27(4):479-485. doi: 10.1111/den.12405. Epub 2014 Dec 11.

  PMID: 25394296 BACKGROUND

• Draganov PV, Lin T, Chauhan S, Wagh MS, Hou W, Forsmark CE. Prospective evaluation of the clinical utility of ERCP-guided cholangiopancreatoscopy with a new direct visualization system. Gastrointest Endosc. 2011 May;73(5):971-9. doi: 10.1016/j.gie.2011.01.003. Epub 2011 Mar 17.

  PMID: 21419408 BACKGROUND

• Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.

  PMID: 21762903 BACKGROUND

• Draganov PV, Chauhan S, Wagh MS, Gupte AR, Lin T, Hou W, Forsmark CE. Diagnostic accuracy of conventional and cholangioscopy-guided sampling of indeterminate biliary lesions at the time of ERCP: a prospective, long-term follow-up study. Gastrointest Endosc. 2012 Feb;75(2):347-53. doi: 10.1016/j.gie.2011.09.020.

  PMID: 22248602 BACKGROUND

• Robles-Medranda C, Valero M, Soria-Alcivar M, Puga-Tejada M, Oleas R, Ospina-Arboleda J, Alvarado-Escobar H, Baquerizo-Burgos J, Robles-Jara C, Pitanga-Lukashok H. Reliability and accuracy of a novel classification system using peroral cholangioscopy for the diagnosis of bile duct lesions. Endoscopy. 2018 Nov;50(11):1059-1070. doi: 10.1055/a-0607-2534. Epub 2018 Jun 28.

  PMID: 29954008 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Histological biopsies of tissular lesions of bile duct

Study Officials

• Carlos A Robles-Medranda, MD

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2016
• First Posted: June 9, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

EC (1)