Our goal is to perform a multicenter randomized study to compare a less invasive diagnostic workup ARM A (with MRI and surgical inspection reserved for borderline operable cases on MRI) to the standard diagnostic workup (ARM B, without MRI, with…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of preventable unnecessary laparoscopies and explorative laparotomies
Secondary outcome
-- Number of additional extra-peritoneal findings
- Number of early recurrences (with-in 6 months after R1 resection and HIPEC)
- Diagnostic performance of Peritoneal Cancer Index determined by MRI (MRI-PCI)
to predict surgical Peritoneal Cancer Index (S-PCI).
- Inter-observer agreement between different readers for DW-MRI.
- Incremental costs, effects, and incremental cost-effectiveness ratio.
- Quality of life between diagnostic arms
Background summary
MRI is a potentially powerful tool to reliably determine the intra-abdominal
tumor load and relations with intra-abdominal organs. In recent years diffusion
weighted MRI has proven its value as a highly sensitive technique to detect
small malignant disease in a wide variety of cancers [1-3]. However, literature
concerning the clinical impact of detecting peritoneal metastases with MRI is
very limited. Therefore, there is a need for a large randomized multicenter
trial to determine whether dedicated MRI can be used as a selection tool for
CRS-HIPEC candidates in daily practice.
Study objective
Our goal is to perform a multicenter randomized study to compare a less
invasive diagnostic workup ARM A (with MRI and surgical inspection reserved for
borderline operable cases on MRI) to the standard diagnostic workup (ARM B,
without MRI, with surgical staging to determine resectability based on a MDT
decision) of patients with (suspected) peritoneal metastases. Surgical staging
laparoscopies may largely be replaced by MRI (only reserved as a problem solver
for borderline operable cases in ARM A). If we can prove that MRI is an
accurate, robust and cost-effective staging tool than this will result in a
more patient friendly diagnostic workup with less futile surgical procedures.
Study design
Multicenter randomized trial.
Patients, suspected of having colorectal peritoneal metastases and considered
for CRS-HIPEC, will be included. Patients will be randomly assigned after
inclusion to one of two diagnostic arms towards CRS/HIPEC. In arm A, the
experimental arm, patients will undergo dedicated MRI imaging of the pelvis,
abdomen, and thorax. In arm B will undergo the current standard diagnostic
work-up of DLS at indication (MDT decision) and otherwise continue to
CRS-HIPEC.
Study burden and risks
MRI is a standard diagnostic procedure without the use of radiation. The MR
sequences, MR-contrast agents and Buscopan (to mimimize peristaltic bowel
movements) are all commonly used in daily clinical practice. In addition,
patients will be asked to drink 1L of pineapple juice 1 hours before the MRI
(to minimize signal in the bowel lumen and optimize image quality), which is
standard procedure in many clinics for MRCP and MR enterography. By acting upon
the MRI findings in the experimental arm A, could result into new risks as
oppose to standard clinical practice. However by introducing the borderline
group (*yellow light* group) to receive diagnostic laparoscopy will minimize
the possibility of over-staging a patient that would have received a successful
CRS/HIPEC in de control arm.
Burden
- Per MRI 35 minutes for MR imaging procedure ,
- 1 hr before the MRI drink 1 ltr of pineapple juice according to
standard care.
- 1 (Group B) of 2 (Group A) extra visits for the MRI, total time per
visit is expected to be 2 hrs
- For Group A is the total burden is 4 hours as for Group B 2 hours in 8
months
- QOL questionnaire: 3 times, 15 minutes per questionnaire
Risks:
• Gadolinium and Buscopan will be administrated intravenously. A potential side
effect that can occur as a result of the administration is an allergic
reaction. Although it is known that the side effects of Gadolinium /Buscopan
are limited and occur in only a very limited number of patients, the
possibility of serious or life-threatening anaphylactic or anaphylactoid
reactions.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with suspicion of colorectal peritoneal metastases and considered
for CRS/HIPEC
- Age >18 years
- Written and signed informed consent
- WHO 0-2
- Able and willing to drink 1 liter of pineapple juice
Exclusion criteria
- Patients with contraindications for MRI:
- Patients who have a heart pacemaker may not have an MRI scan
- Patients who have a metallic foreign body (metal sliver) in their body
- Patients with severe claustrophobia
- Ineligibility to receive gadofosveset (Gadolinium) contrast (history of
contrast allergy, impaired kidney function with a Glomerular Filtration Rate
<30 ml/min/1.73m2)
- Ineligibility to receive Buscopan
- Allergy for pineapple juice and blueberry juice.
- Patients with clinical contraindications for CRS/HIPEC
- Patients with radiological contra-indications for CRS/HIPEC observed on CT
thorax/abdomen
- Massive mesenteric or small bowel involvement which would lead to short bowel
syndrome if adequately resected
- Extra-peritoneal metastases for which CRS/HIPEC is not justifiable (such as
lung metastases, skeletal metastases, and liver metastases)
- Known additional malignancy, unless treated with curative intent at least
five years ago. In situ cancers, basal cell carcinoma of the skin or squamous
cell carcinoma of the skin that have undergone potentially curative therapy
within the past five years may also be eligible.
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 | NL70045.031.19 |