The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with…
ID
Source
Brief title
Condition
- Bile duct disorders
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of peroral cholangioscopy (POCS) visualization and
POCS-guided biopsy for cholangiocarcinoma, precursors to cholangiocarcinoma or
benign disease in patients with PSC, evaluated clinically at 12 months after
initial POCS procedure.
Secondary outcome
1. Technical success: Ability to advance the cholangioscope to the target
stricture, ability to visualize the stricture and ability to obtain a tissue
sample with SpyBite where applicable.
2. Serious adverse events from initial POCS procedure until end of follow-up.
3. Proportion of patients identified for repeat procedure considering the
addition of SpyGlassTM DS visualization and SpyBiteTM biopsy at Index compared
to the proportion identified for repeat procedure without consideration of
SpyGlass DS visualization and SpyBiteTM biopsy at Index.
4. Correspondence between histopathology of SpyBiteTM biopsies collected during
the initial POCS procedure and final diagnosis.
5. Correspondence between diagnostic outcome based on POCS and diagnostic
outcome based on alternative imaging modalities performed for the same
indication (timepoint), such as MRI/MRCP, US, CT, PET.
Background summary
The greatest clinical challenge subsequent to PSC diagnosis involves evaluating
the risk of cholangiocarcinoma. Individual imaging modalities, including the
preferred MRCP, CT, and US, have low negative predictive value (NPV) in the
diagnosis of cholangiocarcinoma.4,5 This is primarily due to the low
sensitivity of detecting cholangiocarcinoma in PSC, as in its early stages a
lesion may not be identifiable on CT or MRI scans. Although non-invasive
imaging is preferred for routine follow-up, exploration with ERCP has become
standard of care for symptomatic patients and asymptomatic patients in whom
disease progression is a concern.4,3 In these cases, biopsy and cytology are
performed in the setting of indirect ERCP- guided visualization of the hepatic
ducts. However, cytology and/or biopsy under indirect visualization may not
capture adequate malignant tissue, if present, in PSC patients with fibrotic
bile duct strictures, precluding a definitive diagnosis.
Cholangioscopy with the SpyGlassTM system overcomes some of these obstacles
because biopsies of the bile duct can be collected under direct visualization.
An additional advantage of cholangioscopy is the direct visual impression of
the lumen, which can be evaluated by the endoscopist for malignant appearance
(such as neovascularization) in cases in which a visible mass is absent on
MRI/CT, but concerning cholestatic or other clinical symptoms of malignancy are
present.
Study objective
The primary objective of this study is to demonstrate the clinical utility of
the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing
cytology for diagnosis and early detection of cholangiocarcinoma in patients
diagnosed with primary sclerosing cholangitis (PSC).
Study design
Prospective, Multi-center, Non-Randomized, Consecutive series
Intervention
In addition to standard ERCP with bile duct brushings a SpyGlass system will
be introduced through the endoscope in the bile ducts for visualization of
suspicious strictures. In addition, SpyBite biopsies form suspicious sites will
be taken through the system
Study burden and risks
The burden to patients is that they have to undergo one additional blood test
drawn, a baseline visit and end-of-study visit and 3 telephone visits.
The index procedure is not different from a routinely carried out Spyglass
ERCP. Regarding the indication for ERCP, in the majority of patients
cholangioscopy would be performed anyway.
Boston Scientific Way 100
Marlborough MA01752
US
Boston Scientific Way 100
Marlborough MA01752
US
Listed location countries
Age
Inclusion criteria
Confirmed diagnosis of PSC
2. Clinical indication for ERCP per local standard of practice, such as
suspicion of potential malignancy based on worsening cholestatic values or
clinical presentation (such as itching, cholangitis) or new biliary stricture
on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology
3. Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy
system based on baseline imaging performed within 3 months prior to scheduled
ERCP
4. Written informed consent from patient to participate in the study, including
compliance with study procedures.
Exclusion criteria
1. Contraindication for an ERCP or POCS
2. History of liver transplantation
3. Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging
4. History of iatrogenic bile duct trauma, including biliary surgery within 6
months of enrollment
5. INR > 1.5 or platelets count < 50,000
6. Age < 18 years
7. Pregnant women or women trying to become pregnant
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03766035 |
| CCMO | NL68889.018.19 |