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

Not Applicable

• Conditions: Colorectal Neoplasms; Neoplasm Metastasis
• Interventions: Other: Lymph node clearing technique with Carnoy solution; Other: Lymph node clearing technique with GEWF solution

• Registration Number: NCT02495532
• Lead Sponsor: Hospital Moinhos de Vento

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-16
• Status Verified: 2015-07
• Study First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Study First Posted: 2015-07-13
• Last Update Posted: 2015-07-13
• Primary Completion: 2018-02
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Histologically proven colorectal adenocarcinoma
• Voluntary agreement of the patient to participate in research
• Voluntary agreement of the surgeon to participate in research

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Exclusion Criteria

• Absence of accurate histopathological data

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colon Cancer	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
Rectal Cancer	Lymph node clearing technique with Carnoy 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
Colon Cancer	Lymph node clearing technique with Carnoy 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
Rectal Cancer	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

Primary Outcome Measures

Name	Time	Method
Lymph nodes harvested	One week	Number of additional lymph nodes harvested with the clearing technique

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil