The primary objective is to determine the feasibility of the in vivo sentinel node procedure in patients with colon carcinoma, during open and minimal invasive surgery.The secondary objective of the study is awareness and knowledge of (non)sentinel…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of successful SN-procedures.
Secondary outcome
Number of problems encountered during the SN-procedure. Number of resected and
examined lymph nodes in the SN-group and the standard group. Number of examined
lymph nodes when the pathologist is handed a X-ray of the specimen.
Background summary
In the Netherlands colorectal cancer is a significant cause of morbidity and
mortality. Lymph node involvement is the most important predictor of prognosis.
The five-year survival rate for stage I and II is 70-90%, but only 45-50% in
case of metastatic spread to lymph nodes (stage III). Adjuvant chemotherapy
improves the five-year survival in this last group. Recurrence after resection
occurs in 20-30%, possibly because of understaging in case of undetected occult
metastases. The sentinel node can facilitate time consuming and expensive
pathological examination by identifying single lymph nodes that harbor the
greatest potential of metastasis and visualize aberrant lymphatic drainage.
This may lead to an increased number of resected and analyzed lymph nodes,
which itself, is a prognostic variable on outcome. The SN-procedure may lead to
a better selection of high-risk patients who could benefit from additional
adjuvant treatment.
Study objective
The primary objective is to determine the feasibility of the in vivo sentinel
node procedure in patients with colon carcinoma, during open and minimal
invasive surgery.
The secondary objective of the study is awareness and knowledge of
(non)sentinel nodes in colon cancer. The third objective is whether or not a
X-ray of the specimen will increase the lymph node yield after a dissection is
performed.
Study design
The study is designed as a prospective, single centre pilot, consisting of 2
SN-groups of 10 patients that will undergo open or minimal invasive surgery.
And a control group of 10 specimens of patients treated earlier this year. In
the SN-groups 1 cc of patent blue will be injected in the wall of the bowel
near the tumor, with identifying of the SN and resecting it separately. The SN
will be tested not only with HE-staining but also IHC and RT-PCR and in some
cases a X-ray of the specimen will be added.
Study burden and risks
The burden consists of about 30 minutes of providing information on the study
and time to read and sign the informed consent. Benefits are more accurate
staging of the disease enabling more adequate additional treatment. Risks are
mild to severe allergic reactions to patent blue, which can be treated
adequately with the usual therapeutics and the potential risk of extension of
the duration of the surgery.
meibergdreef 9
1105 AZ Amsterdam
Nederland
meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Resectabel colon cancer treated with segmental colectomy, in an elective setting, open or minimal invasive.
>18 years
ASA I-III
no known allergy for patent blue
Exclusion criteria
rectal cancer
earlier colonic surgery
pregnancy
age <18 years
emergency surgery
earlier chemo- or radiotherapy
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 | NL29174.018.09 |