Study Results
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Basic Information
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COMPLETED
130 participants
OBSERVATIONAL
2015-12-31
2016-12-31
Brief Summary
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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
Detailed Description
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Population selection:
Stage 1: 63 patients enrolled with bile duct tissular lesion detected by POCS. Cholangioscopic lesions images (315) were photographically recorded in order to correlate to, histopathology after targeted or surgical biopsies, and 6 months follow up with POCS. Using the histopathology results, the lesions were classified into benign or malignant. An experienced endoscopist with more than 140 POCS analyzed the images based on the morphological and vascular pattern and performed a POCS macroscopic classification of tissular bile duct lesions as follow: Benign lesions: Type 1 "Villous pattern" (micronodular or villous pattern without vascularity), Type 2 "Polypoid pattern" (adenoma or granuloma pattern without vascularity) and Type 3 "Inflammatory pattern" (regular or irregular fibrous and congestive pattern with regular vascularity). Malignant lesions: Type 1 "Flat pattern" (flat and smooth or irregular surface with irregular or spider vascularity); Type 2 "Polypoid pattern" (polypoid or mass shape with fibrosis and irregular or spider vascularity), Type 3 "Ulcerated pattern" (irregular ulcerated and infiltrative pattern with or without fibrosis and with irregular or spider vascularity) and type 4 "honey-comb pattern" (fibrous honey-comb pattern with or without irregular or spider vascularity).
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 (classification group) will use the previous classification to select the images as benign or malignant with the different subtypes; and the second group (no classification group or control group) will do it without using the classification.
Endoscopic technique:
Stage 1: patients included were evaluated using a standard duodenoscope (Pentax ED 3670TK, Hoya Co.), the Pentax Video Processor EPK-i5010 and both SpyGlass® cholangioscopes: First generation, SpyGlass® Direct Visualization System and Second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA) in a mother-baby manner. Procedures were performed by one experienced endoscopists with more than 300 ERCP/year (C.R.M), in the supine position and under general anesthesia. All patients received antibiotic prophylaxis. Biopsies were taken in order to correlate to histopathology.
Stage 2: patients will be evaluated using a standard duodenoscope (Pentax ED 3670TK, Hoya Co.), the Pentax Video Processor EPK-i7010 and second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA) in a mother-baby manner. Procedures will be performed by two experienced endoscopists with more than 300 ERCP/year (C.R.M and M.S.A), in the supine position and under general anesthesia. Half of patients will receive antibiotic prophylaxis because an ongoing cholangioscopic antibiotic prophylaxis protocol. Biopsies will be taken in order to correlate to histopathology.
Inter and intra-observer agreement Stage 1: A data set containing 40 random photographs of the bile duct lesions were presented to 1 expert and 2 non-experts in POCS, whom analyzed the images blindly. Intra and inter-observer reproducibility was measure based on comparison of images between endoscopists.
Stage 2: Intra and inter-observer agreement will be performed in the same manner as stage1.
Statistical analysis: Baseline characteristics will be compared between groups using Chi-square o Fisher Test for categorical variable and Mann-Whitney Test for continuing variables. Accuracy, sensitive, specificity, positive and negative predicts value will be calculated. To examine inter and intra observer agreement, kappa values will be calculated. A P value of less than 0.05 is considered to be statistically significant. All the statistical analysis will be performed using SPSS software suite v.22.
Limitations: the protocol will be performed in only one center.
Conditions
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Keywords
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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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
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Who agree to participate in the study
* Patients with tissular biliary lesions detected by POCS
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Instituto Ecuatoriano de Enfermedades Digestivas
OTHER
Responsible Party
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Principal Investigators
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Carlos A Robles-Medranda, MD
Role: PRINCIPAL_INVESTIGATOR
Ecuadorian Institute of Digestive Diseases
Locations
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Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital
Guayaquil, Guayas, Ecuador
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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MAY-1-2016
Identifier Type: -
Identifier Source: org_study_id