To determine the technical feasibility of cholangioscopy using the Spyglass DS II system in the pre-operative work-up of resectable EC.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Technical feasibility to perform cholangioscopy in EC, defined as the technical
success to advance the Spyglass DS II cholangioscope through the malignant
stricture into the intended (segmental) bile duct system(s), to assess ductal
tumor borders optically and to obtain mapping biopsies of the locations of
interest depending on the predetermined resection lines.
Secondary outcome
1. Overall diagnostic value of optical cholangioscopic assessment combined with
biopsies of bile duct locations at interest outside the predetermined resection
lines.
2. Diagnostic value of optical cholangioscopic assessment or biopsies alone.
3.Adverse outcomes after cholangioscopy defined by any cholangioscopy-related
AE or mortality within 30 days. The AE will be recorded according the ASGE
lexicon.
Background summary
Assessment of malignant bile duct extension is essential in pre-operative
staging of extrahepatic, perihilar or distal, cholangiocarcinoma (EC). Current
diagnostic tests, including MRI/MRCP, are considered suboptimal in assessing
longitudinal tumor growth. Cholangioscopy is a new endoscopic imaging technique
performed during ERCP which provides direct visualization of the bile duct
system, which also allows targeted biopsies.
Study objective
To determine the technical feasibility of cholangioscopy using the Spyglass DS
II system in the pre-operative work-up of resectable EC.
Study design
Prospective pilot study in two referral centers.
Study burden and risks
Study related procedures will only be performed in patients already scheduled
for ERCP. All patients have already consented for complications associated with
an ERCP, including pain, hemorrhage, post-ERCP pancreatitis and perforation.
Performing cholangioscopy during ERCP does not increase the risk of
postprocedural complications. It will only prolong procedure time with an
additional 20 minutes estimated. As patients are already sedated during ERCP
adding cholangioscopy will not increase the burden of the endoscopic procedure.
The presumed benefit of cholangioscopy is a change in pre-operative staging. In
case finings of cholangioscopy incl biopsies differ from MRI/MRCP results, this
will be discussed in the MDT. This may change management. Seldomly,
cholangioscopy with biopsies demonstrate a benign bile duct disease instead of
malignancy.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with resectable EC undergoing ERCP to achieve pre-operative biliary
decompression of the FRL
- (Suspicion of) EC is based on clinical assessment and imaging results
(MRI/MRCP and CT), histological confirmation is not obligatory.
- Resectability of the tumor was evaluated at the regional multidisciplinary
team meeting
- Biliary stenosis located distally, or perihilar according to Bismuth
classification based on imaging results (MRI/MRCP/CT)
- Informed consent
- Age >= 18 years
Exclusion criteria
• Intrahepatic cholangiocarcinoma
• Irresectable tumor
• Previous treatment with a biliary plastic endoprothesis or self-expandable
metal stent (SEMS)
• Previous treatment with a percutaneous transhepatic biliary drain
• Patients with expected very limited survival (< 6 weeks)
• Biliary obstruction not amenable to endoscopic drainage, for example due to
altered anatomy
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 |
|---|---|
| CCMO | NL75313.041.21 |