To assess the feasibility of CT based 3D preoperative resection planning for hepatectomy and postoperative resection confirmation through image fusion of pre- and postoperative 3D CT reconstructions.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study endpoint is the feasibility of preoperative planning for surgical
resection of liver tumors and the ability to compare post-operative 3D
reconstruction of the hepatectomy results to the preoperative 3D surgical
planning
Endpoints are:
- The number of patients in which the analysis was possible
- Differences in preoperatively planned resection and margin measurements
compared to the achieved resection and resection margins
Secondary outcome
Secondary study endpoints are assessment and correlation of the surgical
margins as measured between 3D reconstructions to the histopathological
margins, and evaluation of the process of creating the 3D preoperative
planning, usability in determining resection plane and the ability to determine
post-operative technical success and resection margins.
Endpoints are:
- Volumetric measurements of the resection margins on 3D reconstructions
- Correlation and comparability between histopathological margins and margins
measured on 3D reconstructions
- Scoring of process of segmenting and creating the 3D models, and
co-registering and assessing postoperative technical success.
Background summary
Complete surgical resection is considered one of the main curative treatment
options for liver tumors. Complete resection requires clean resection margins,
which depends on tumor volume, location, potential to spare sufficient
parenchyma and relation to vital intrahepatic structures. A correct assessment
of all these factors forms the basis for a well-thought-out plan prior to the
operation. In current practice the surgeon prepares for the resection through
2D radiological imaging, i.e. (CE-) CT and MRI scans. The value of
cross-sectional imaging for this preoperative planning is great, but
translation of 2D images from a regular CT to the 3D intraoperative reality is
not easy. The liver is a complex organ with differing anatomy between
patients. To better prepare and review the relation between tumor and
surrounding tissue, a 3D segmentation and reconstruction can be made from the
available imaging. This allows for better visualization of the tumor within the
liver and for pre-operative planning of the resection within the parenchyma and
distance to critical structures. It is however unknown if the preoperative plan
influences surgical technical result and how well the preoperative plan can be
adhered.
Additionally, from post-operative CT scans a 3D reconstruction can be made in a
similar way. The pre- and post-operative 3D reconstructions and scans can
potentially be used to assess adherence to the preoperative plan and evaluate
surgical resection margins
Study objective
To assess the feasibility of CT based 3D preoperative resection planning for
hepatectomy and postoperative resection confirmation through image fusion of
pre- and postoperative 3D CT reconstructions.
Study design
Prospective single center explorative pilot study
Study burden and risks
The participating patients will undergo an additional CECT scan 1-3 days
postoperatively during hospitalization after the liver resection surgery. The
surgery itself will be performed according to standard procedures. According to
the study procedures, an additional pre-operative 3D reconstruction of the CT
will be performed. The 3D reconstruction is based on information already
available in the imaging data and will therefore not provide extra information
that could otherwise be unknown. The virtual surgical planning will be made by
the treating surgeon after the surgery, to prevent influence on the surgery
itself.The post-operative CT scan and contrast agents will place extra burden
on the patient due to additional ionizing radiation and contrast agents. To
ensure the additional contrast agents poses no harm to the patient, poor kidney
function (eGFR < 30 mL/min/1.73m2) has been included as an exclusion criterion
for participation. The additional radiation dose is thought to be negligible
compared to the overall surgical procedure, clinical workup and follow-up of
the patients. Total additional radiation dose will be calculated by clinical
physicists.
The outcome of this pilot study could provide additional proof of the benefits
of 3D preoperative planning for liver surgery and establish the implementation
of additional image reconstruction prior to the surgery. This can improve the
surgeon's ability to prepare for the surgery and reduce surgery time, reduce
risk to critical structures and increase the chance of achieving sufficient
margins.
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Geert Grooteplein Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Patients who will undergo (partial) liver resection
A contrast enhanced CT scan of sufficient quality for preoperative 3D
reconstruction
Exclusion criteria
Prior hepatectomy
Patients unable to undergo additional contrast enhanced imaging, including
those with contraindications for CT scans or contrast agents.
<16 years of age
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 | NL86289.091.24 |