The primairy aim of this pilot study is to evaluate the feasibility of systematic survey by EUS-FNA/FNB.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To evaluate the feasibility of systematic survey of regional and non-regional
lymph nodes by EUS-FNA/FNB, defined as:
o Number of patients in which all potential lymph node locations were
successfully surveyed and FNA/FNB is possible when indicated.
Secondary outcome
- To correlate regional and non-regional lymph nodes identified by EUS to
cross-sectional imaging and surgery, defined as:
o Number of lymph nodes correctly identified as malignant based on
visualization and biopsy in comparison to cross-sectional imaging and surgery
- To evaluate the different locations of positive lymph nodes and its effect on
survival, defined as:
o Days of survival after EUS and surgery per N0, N1, N2 or M status.
- To identify short term and long term complications of EUS-FNA/FNB in
detecting lymph nodes in patients with pCCA, defined as:
o Short term (<30 days)
* Sedation related: consisting of cardiovascular-related complications (cardiac
arrhythmias, myocardial ischemia/infarction), respiratory- related
complications (respiratory depression, hypoxia, airway obstruction, pulmonary
aspiration of gastric contents) and allergic reactions.
* Hemorrhage (outside peritoneal wall): defined as clinical evidence of
bleeding with a hemoglobin drop of >3g/dl with the need for resuscitation or
additional intervention
* Perforation: defined as evidence of air or luminal contents outside the
gastro-intestinal tract together with clinical symptoms, requiring percutaneous
drainage or surgery
* Mortality
o Long term (>30 days)
* Tumor seeding; defined as proof of carcinoma in the biopsy tract during
follow-up or at autopsy
Background summary
The survival of patients with perihilar cholangiocarcinoma (CCA) is limited, as
pCCA is often recognized in a relatively late stadium, making it ineligible for
surgical resection, which is the only potentially curative treatment. The
resectability of pCCA depends on local tumor extension, vascular involvement
and presence of metastatic disease. Both distant and lymph node metastases are
determining the choice of treatment and the prognosis, since the prognosis of
patients with N2 lymph nodes or distant metastases is not altered by
loco-regional surgery, and therefore surgical resection is contraindicated.
Moreover, survival for patients with positive N1 lymph nodes is very poor and
the small oncological advantage may not justify the surgical risk in some of
these patients. Therefore, correct lymph node assessment is crucial, which is
often difficult to determine preoperatively with cross-sectional imaging.
Endoscopic Ultrasound (EUS) with Fine Needle Aspiration (FNA) or Fine Needle
Biopsy (FNB) of the lymph nodes might be a more accurate method to assess lymph
node staging, which might lead to a better preoperative shared decision making,
since patients might be spared from invasive surgical treatments. Therefore,
the aim of this pilot study is to evaluate the feasibility of systematic survey
by EUS-FNA/FNB. In addition, the accuracy of lymph node assessment with
EUS-FNA/FNB and its impact on clinical decision making will be compared to
current state-of-the-art cross-sectional imaging (CT scan and Pet-MRI) and
complications of EUS-FNA/FNB will be evaluated.
Study objective
The primairy aim of this pilot study is to evaluate the feasibility of
systematic survey by EUS-FNA/FNB.
Study design
In preparation of a prospective multi-centered study, we aim to perform a pilot
study at Erasmus MC, including 10 patients. The expected inclusion period is 6
months.
Intervention
In each patient with suspected resectable pCCA a systematic survey of regional
and non-regional lymph nodes will be performed on cross sectional imaging, on
EUS (with FNA or FNB of suspicious lymph nodes if present) and, when performed,
during surgery.
Study burden and risks
In all patients with presumed resectable pCCA cross sectional imaging is
performed. EUS is performed as standard if suspicious lymph nodes are present
on imaging, but systematic survey of and reporting on the lymph nodes is not
done. In patients without suspicious lymph nodes an additional EUS is
performed, but with low risks. Due to systematic survey of the lymph nodes in
all patients, a better estimate can be made about which patients benefit from
the invasive curative-intent surgery and which patients do not because of the
presence of positive lymph nodes. So, the benefit of this study is to spare
patients from invasive surgery by identifying positive non-regional lymph nodes
with EUS-FNA/FNB.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Presumed resectable pCCA.
- Written informed consent must be given according to ICH/GCP, and
national/local regulations.
- Age > 18 years.
Exclusion criteria
- Patients with a history of treated pCCA
- Patients with a history of treated liver malignancy
- Patients with a contra-indication for EUS + FNA/FNB (f.e. uncorrectable
coagulopathy or platelet disorder), in line with current clinical practice
Design
Recruitment
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 | NL78298.078.21 |