Colorectal Neoplasms, Neoplasm Metastasis
Conditions
Keywords
Neoplasm Metastasis, Colorectal Neoplasms, Lymph Nodes, Lymph Node Revealing Solution
Brief summary
Regional lymph node metastasis is a major determinant of local recurrence and overall survival rates in patients with colorectal cancer. Because of the poor prognosis associated with the presence of lymph node metastasis, stage III colorectal cancer patients should receive adjuvant treatment with chemo and / or radiation therapy according to the site of tumor. Several authors have investigated the use of revealing solutions for lymph node clearance in colorectal cancer. Most studies comparing conventional histopathological specimen examination to any lymph node clearing technique showed that the use of revealing solutions increases the mean number of lymph nodes harvested, usually in a statistically significant manner. It is still controversial the impact of the use of revealing solutions for upstaging of lymph node status and consequently for the indication for adjuvant therapy. Therefore will be conducted a randomized clinical trial to compares the performance of GEWF and Carnoy solutions for the histopathological examination of patients with colorectal cancer. The aim of this study is to determine the lymph node revealing solution with the best performance (increase in the mean number of lymph node harvested and lymph node upstaging) in patients with colorectal cancer.
Detailed description
Patients with histologically proven colorectal adenocarcinoma submitted to curative resection and conventional histopathological examination of the surgical specimen are randomized to undergo further investigation by lymph node clearing technique with Carnoy or GEWF solution.
Interventions
OTHERLymph node clearing technique with Carnoy solution
Procedure: lymph node clearing technique with Carnoy solution (1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with Carnoy solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy.
OTHERLymph node clearing technique with GEWF solution
Procedure: lymph node clearing technique with GEWF solution (1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with GEWF solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy.
Sponsors
Federal University of Health Science of Porto Alegre
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proven colorectal adenocarcinoma * Voluntary agreement of the patient to participate in research * Voluntary agreement of the surgeon to participate in research
Exclusion criteria
* Absence of accurate histopathological data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph nodes harvested | One week | Number of additional lymph nodes harvested with the clearing technique |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node metastasis | One week | Presence of metastasis in the additional lymph nodes harvested |
| Upstage of lymph nodes | One week | Diagnosis of lymph node metastasis in a patient initially classified as having no lymph node metastasis or increase in the number of metastatic lymph nodes in a patient already staged as having lymph node metastasis. |
| Adjuvant therapy | One month | Indication of adjuvant therapy as consequence of the upstaging after the lymph nodes clearing technique. |
Countries
Brazil
Contacts
Primary ContactTiago L Ghezzi, MD, PhD
Outcome results
None listed