Clinical trial NCT02495532: Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer
Official title: Randomized Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Keywords: Neoplasm Metastasis
Colorectal Neoplasms
Lymph Nodes
Lymph Node Revealing Solution
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Federal University of Health Science of Porto Alegre
First posted: 2015-07-13
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lymph nodes harvested
timeFrame: One week
Secondary outcomes:
measure: Lymph node metastasis
timeFrame: One week
measure: Upstage of lymph nodes
timeFrame: One week
measure: Adjuvant therapy
timeFrame: One month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande do Sul
Study officials:
affiliation: Researcher
name: Antonio N Kalil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: