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

NCT02495532 | Unknown

• 1 other identifier: 39919814.7.0000.5330
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Keywords

Neoplasm Metastasis; Colorectal Neoplasms; Lymph Nodes; Lymph Node Revealing Solution

Outcome Measures

Primary Outcomes (1)

• Lymph nodes harvested

  Number of additional lymph nodes harvested with the clearing technique

  One week

Secondary Outcomes (3)

• Lymph node metastasis

  One week

• Upstage of lymph nodes

  One week

• Adjuvant therapy

  One month

Study Arms (2)

Colon Cancer

ACTIVE COMPARATOR

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

Rectal Cancer

ACTIVE COMPARATOR

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

Interventions

Lymph node clearing technique with Carnoy solution OTHER

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

Colon Cancer; Rectal Cancer

Lymph node clearing technique with GEWF solution OTHER

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

Colon Cancer; Rectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Absence of accurate histopathological data

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Federal University of Health Science of Porto Alegre: collaborator

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035001, Brazil

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

methacarn; gewf solution

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio N Kalil, MD, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiago L Ghezzi, MD, PhD

CONTACT

+ 555197256265; tlghezzi@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: July 13, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

BR (1)