The primary objective of this study is to determine the accuracy of the application of stereotactic navigation combined with 3D MRI topography during oncologic resection for primary locally advanced rectal cancer in which the tumor is grown in or…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary ouctome measure is the accuracy of stereotactic navigation defined
by the distance between predefined anatomical landmarks that are pointed out by
means of a tracked instrument by the surgeon intraoperatively (and marked on
the transverse, coronal and sagittal MRI images if applicable) and the actual
location of this anatomical landmark in the scan that is marked
pre-operatively.
Secondary outcome
The secondary outcome measures are:
- the pathological radicality of the resection as a dichotomous variable: R0 or
R1/R2 resection
- whether the surgeon was able to locate the preoperatively marked lesion to
his opinion
The third outcome measures are a questionnaire assessing the user satisfaction
and the functional outcome of the patient.
Background summary
Improvements in surgical care for locally advanced and recurrent rectal cancer
patients are needed. The current rate of irradical resections is unacceptably
high with up to a quarter of resections in locally advanced and half of
resections in recurrent rectal cancer patients being irradical. This is
associated with a high chance at locoregional recurrence, development of
metastases and therefore adversely affects the life-expectancy and quality of
life. Nowadays, surgeons plan the operation before surgery merely by analyzing
MRI images before the operation but have no tool to verify the correct plane of
dissection during surgery. We propose image-guided pelvic surgery to optimize
surgical precision and thereby oncological and functional outcome by
application of stereotactic navigation combined with 3D MRI segmentations of
the tumor and relevant surrounding structure. Surgical navigation is expected
to improve the quality of surgery for locally advanced and recurrent rectal
cancer in which it is difficult or impossible to identify and dissect along
anatomical planes as shown when used in other contexts, especially when
combined with 3D MRI-topography. The aim of this pilot study is to assess the
accuracy of the application of stereotactic navigation combined with 3D
MRI-topography during surgery for locally advanced and recurrent rectal cancer.
Study objective
The primary objective of this study is to determine the accuracy of the
application of stereotactic navigation combined with 3D MRI topography during
oncologic resection for primary locally advanced rectal cancer in which the
tumor is grown in or beyond the visceral peritoneum (T4ab) and for recurrent
rectal cancer. The secondary objective: Evaluation of the user satisfaction of
this type of image-guided surgery.
Study design
Monocenter, interventional, prospective, longitudinal clinical study.
Intervention
Calibration of the position of the patient in the operating theatre and that of
the tip of a surgical instrument by using a c-arm.
Study burden and risks
The risks for the participating patients include:
- Extra radiation exposure of maximal 3.6 mSv (maximum of 3 3D runs c-arm).
- Reduced surgical precision in case of malfunctioning navigation system or
incorrect registration and unawareness by the surgeon with an associated
increased chance at iatrogenic injury or irradical resection.
However, with a yearly background radiation of ~2,5 mSv and a radiation of ~4,0
mSv associated with a regional flight in West-Europe, 3.6 mSV is only a limited
amount of radiation and too small to demonstrate an association with the
occurrence of cancer or congenital defects. Additionally, the application of
surgical navigation systems are well expected to improve the quality of surgery
for rectal cancer as shown when used in other contexts, especially when
combined with 3D MRI-topography.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Male or female
2. Age >= 18 years
3. Primary cT4abN0-2 rectal cancer or recurrent rectal cancer with an
indication for resection after neoadjuvant treatment
4. Lithotomy position during the whole procedure
5. Laparoscopic approach
6. Laparotomic approach
7. Signed informed consent (addendum 15)
Exclusion criteria
1. Threatened anterior circumferential resection margin negated through the
performance of a (posterior) pelvic exenteration
2. Tumor involvement sacrum cranial to the junction of S2/S3 and cT4b
3. Tumor involvement of common or external iliac artery/vein
4. Tumor involvement of hypogastric artery bilaterally
5. Tumor involvement of the lumbosacral plexus, sacral nerve 1, sacral nerve 2
or sacral nerve 3
6. Patient operated in semi-elective or acute setting
7. Inclusion in another study (randomised clinical trial)
8. Patient classified as American Society of Anaesthesiologist Class >= 4
9. Patient is unable to speak or understand Dutch
10. Legally incapable
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 |
|---|---|
| Other | NL 8567 |
| CCMO | NL73737.042.20 |