Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer

Hospital Moinhos de Vento

Status: Unknown

Conditions: Neoplasm Metastasis; Colorectal Neoplasms

Treatments: Other: Lymph node clearing technique with GEWF solution; Other: Lymph node clearing technique with Carnoy solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02495532

39919814.7.0000.5330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Colon Cancer

Active Comparator group

Description:

The subjects in this group will undergo intervention by having surgery and lymph node clearing technique. Intervention A: Carnoy solution Intervention B: GEWF solution

Treatment:

Other: Lymph node clearing technique with Carnoy solution

Other: Lymph node clearing technique with GEWF solution

Rectal Cancer

Active Comparator group

Description:

The subjects in this group will undergo intervention by having surgery and lymph node clearing technique. Intervention A: Carnoy solution Intervention B: GEWF solution

Treatment:

Other: Lymph node clearing technique with Carnoy solution

Other: Lymph node clearing technique with GEWF solution