Bile Duct LesionsNCT02794987
Cholangioscopic Classification of Bile Duct Lesions
An observational study of Bile Duct Lesions, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Lesions
- What is being tested?
- SpyGlass® choledoscopy
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 1 siteEcuador
- Study dates
- Dec 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Above 18 years old patients
- Who agree to participate in the study
- Patients with tissular biliary lesions detected by POCS
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ecuador1 site
Instituto Ecuatoriano de Enfermedades Digestivas, Omnihospital
Guayaquil, Guayas, 090505
About this study
Official title: Proposal of a Macroscopic Classification for Tissular Lesions of the Bile Duct Detected During Per Oral Cholangioscopy (POCS)
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
Read the detailed description
Setting: Gastroenterology division of the Ecuadorian Institute of Digestive Diseases (IECED), OmniHospital Academic Tertiary Center. The study protocol and consent form has been approved by the Institutional Review Board and will be conducted according to the declaration of Helsinki. Patients will sign an informed consent.
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
- Bile Duct Lesions
- Being tested
- SpyGlass® choledoscopy
- Keywords
- Bile duct, indeterminate stricture, cholangioscopy, Spyglass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpyGlass® choledoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: SpyGlass® choledoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bile Duct LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos A Robles-Medranda, MD, Principal investigator, Ecuadorian Institute of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794987
- Sponsor's protocol ID
- MAY-1-2016
- Status last verified
- Dec 2016
- First submitted
- 1 May 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 21480000Tieu 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.
PubMed 25394296Draganov 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.
PubMed 21419408Chen 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.
PubMed 21762903Draganov 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.
PubMed 22248602Robles-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.
PubMed 29954008
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal of a Macroscopic Classification for Tissular Lesions of the Bile Duct Detected During Per Oral Cholangioscopy (POCS)
- ClinicalTrials.gov ID
- NCT02794987
- Acronym / sponsor ID
- MAY-1-2016
- Conditions
- Bile Duct Lesions
- Keywords
- Bile duct, indeterminate stricture, cholangioscopy, Spyglass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Setting: Gastroenterology division of the Ecuadorian Institute of Digestive Diseases (IECED), OmniHospital Academic Tertiary Center. The study protocol and consent form has been approved by the Institutional Review Board and will be conducted according to the declaration of Helsinki. Patients will sign an informed consent.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classification group | – | Device: SpyGlass® choledoscopyGroup 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 |
| No classification group | – | Device: SpyGlass® choledoscopyGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Above 18 years old patients
- Who agree to participate in the study
- Patients with tissular biliary lesions detected by POCS
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpyGlass® choledoscopyStage 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. | Device | Classification group, No classification group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Background: PubMed 21480000Seelhoff 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.
- Background: PubMed 25394296Tieu 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.
- Background: PubMed 21419408Draganov 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.
- Background: PubMed 21762903Chen 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.
- Background: PubMed 22248602Draganov 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.
- Derived from this study: PubMed 29954008Robles-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Robles-Medranda, MD principal investigator
Ecuadorian Institute of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Lesions, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794987, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.