An interventional study of Lymph node clearing technique with Carnoy solution and Lymph node clearing technique with GEWF solution in Colorectal Neoplasms and Neoplasm Metastasis, sponsored by Hospital Moinhos de Vento. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-13.
Sponsored by Hospital Moinhos de Vento · Not applicable, Interventional, and Diagnostic
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 126 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
The subjects in this group will undergo intervention by having surgery and lymph node clearing technique. Intervention A: Carnoy solution Intervention B: GEWF solution
Other: Lymph node clearing technique with Carnoy solution · Other: Lymph node clearing technique with GEWF solution
The subjects in this group will undergo intervention by having surgery and lymph node clearing technique. Intervention A: Carnoy solution Intervention B: GEWF solution
Other: Lymph node clearing technique with Carnoy solution · Other: Lymph node clearing technique with GEWF 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.
Also known as: Carnoy
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.
Also known as: GEWF
Lymph nodes harvested
Number of additional lymph nodes harvested with the clearing technique
Time frame: One week
Lymph node metastasis
Presence of metastasis in the additional lymph nodes harvested
Time frame: One week
Upstage of lymph nodes
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.
Time frame: One week
Adjuvant therapy
Indication of adjuvant therapy as consequence of the upstaging after the lymph nodes clearing technique.
Time frame: One month
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Hospital Moinhos de Vento