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Clinical Trial Comparing Carnoy's and GEWF Solutions

NCT02704988 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2019-03-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Carnoy Solution

The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with Carnoy solution

PROCEDURE

GEWF Solution

The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with GEWF solution

Sponsors & Collaborators

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Antonio N Kalil, MD, PhD · Federal University of Health Science of Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-06-30
Completion
2019-01-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02704988 on ClinicalTrials.gov