Mid-Atlantic Research Group Single-Operator Cholangioscopic Assessment of Biliary Strictures
- Conditions
- Biliary Tract Neoplasms
- Interventions
- Device: SOC-directed biopsies using the SpyGlass System
- Registration Number
- NCT02615210
- Lead Sponsor
- Temple University
- Brief Summary
The purpose of this study is to determine if cholangioscopically-directed biopsies provide a higher diagnostic yield for malignancy in the setting of indeterminate biliary strictures when compared to standard means of sampling.
- Detailed Description
Biliary strictures in the absence of a mass are a clinical challenge, as current accepted means of sampling provide suboptimal accuracy. Both biliary brushings for cytology and fluoroscopically-directed biopsies produce highly-variable results. Endoscopic ultrasound with fine-needle aspiration has also been employed with variable results. An additional modality, using a single-operator cholangioscope during endoscopic retrograde cholangiopancreatography (ERCP) to obtain cholangioscopically-directed biopsies offers promise in increasing the yield of sampling. Initial observational studies have shown an improved diagnostic yield, but the technique has not been tested in a randomized, medical effectiveness study to better characterize its actual clinical impact. We aim to compare the technique of biopsy-on-biopsy derived sampling via single-operator cholangioscopy with standard fluoroscopically-directed biopsies and brushings in a pilot study. We also aim to perform a medical effectiveness study on the early use of single-operator cholangioscopically (SOC) in the evaluation of undiagnosed biliary strictures.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Age greater than or equal to 18 years
- Presence of indeterminate biliary strictures with clinical indications for ERCP. Strictures are considered indeterminate when evaluation including cross-sectional imaging is non-diagnostic. Patients who have previously undergone ERCP with sampling will be included, as well as those who have not previously undergone ERCP.
- Strictures located above the intrapancreatic bile duct
- The Subject's physician determines and ERCP is clinically indicated
- Able to provide informed consent
- Prior enrollment in the study or another study evaluating biliary strictures
- Presence of extrahepatic malignancy or previously-diagnosed hepatocellular carcinoma
- Pregnancy
- At-risk populations including prisoners and mentally challenged
- Unwilling to provide informed consent
- Medically unfit to undergo ERCP
- History of liver transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study SOC-directed biopsies using the SpyGlass System SOC-directed biopsies using the SpyGlass System plus standard of care biopsies
- Primary Outcome Measures
Name Time Method Number of malignant diagnoses across hree-sample techniques (Spy bite, forceps biopsy, brushings) 72 Hours Accuracy, sensitivity, and specificity of the three-sample technique (Spy bite, forceps biopsy, brushings) compared to the two-sample technique (forceps biopsy and brushing) in differentiating malignant from benign biliary strictures
- Secondary Outcome Measures
Name Time Method Number of patients who receive additional diagnostic studies without receiving a cancer diagnosis 1 year Patients who receive a repeat ERCP with sampling, cross-sectional imaging, EUS-FNA, IR-guided biopsies, laparoscopy
Endoscopic Satisfaction with SOC-directed biopsy 2 hours Endoscopist subjective outcomes using a Likert scale 1-5
* Ease of obtaining the biopsies
* Confidence that the biopsy was taken from the target lesion
* Confidence that an adequate sample was obtained from the biopsy
* Clinical impression of malignant diseaseTime from procedure to the initiation of treatment (in cases of malignancy) 1 year