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NCT Number: NCT02704988

Clinical Trial Comparing Carnoy's and GEWF Solutions

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.

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Key information

About this study

Colorectal adenocarcinoma patients, consecutively submitted to surgical treatment performed by colorectal surgeons with more than 10 years of professional experience at Hospital Moinhos de Vento (Porto Alegre, Brazil), will have their surgical specimens subjected to conventional anatomopathological examination for the analysis of the lymph nodes (visual and palpation) performed by a highly qualified pathology technician in lymph node clearing technique. The lymph nodes identified in this preliminary examination will be counted and submitted to pathologic examination with hematoxylin and eosin staining for lymph node metastasis by a pathologist with over 10 years of experience. Upon completing this procedure with the patients with colon cancer, those with rectal cancer will be randomized and have their surgical specimens submitted to the lymph node clearing technique with Carnoy's or GEWF solutions, according to the groups below.

  • Colon Cancer Group - Carnoy Procedure: The surgical resection specimen will be embedded in a plastic container with 1000 ml of Carnoy solution for 24 to 48 hours. Carnoy's solution is a fixative composed of 60% ethanol, 30% chloroform and 10% glacial acetic acid. Following, a technician in pathological macroscopy with 10 years of experience will perform a visual and manual assessment of additional lymph nodes for 60 minutes. Each additional lymph node identified will be entirely or partially embedded, depending on the size, in paraffin and subsequently stained with hematoxylin-eosin.The microscopic examination of the slides obtained from the anatomopathological examination with Carnoy's solution will be performed by two pathologists with seven and 25 years of experience, respectively, both with wide experience in lymph node clearing technique.
  • Colon Cancer Group - GEWF Procedure: The surgical resection specimen will be embedded in a plastic container with 1000 ml of GEWF solution for 24 to 48 hours. GEWF solution is a fixative composed of 62.5% ethanol, 21.25% distilled water, 10% formaldehyde and 6.25% glacial acetic acid. Following, a technician in pathological macroscopy with 10 years of experience will perform a visual and manual assessment of additional lymph nodes for 60 minutes. Each additional lymph node identified will be entirely or partially embedded, depending on the size, in paraffin and subsequently stained with hematoxylin-eosin.

The microscopic examination of the slides obtained from the anatomopathological examination with Carnoy's solution will be performed by two pathologists with seven and 25 years of experience, respectively, both with wide experience in lymph node clearing technique.

  • Rectal Cancer Group - Carnoy Procedure: The surgical resection specimen will be embedded in a plastic container with 1000 ml of Carnoy solution for 24 to 48 hours. Carnoy's solution is a fixative composed of 60% ethanol, 30% chloroform and 10% glacial acetic acid. Following, a technician in pathological macroscopy with 10 years of experience will perform a visual and manual assessment of additional lymph nodes for 60 minutes. Each additional lymph node identified will be entirely or partially embedded, depending on the size, in paraffin and subsequently stained with hematoxylin-eosin.The microscopic examination of the slides obtained from the anatomopathological examination with Carnoy's solution will be performed by two pathologists with seven and 25 years of experience, respectively, both with wide experience in lymph node clearing technique.
  • Rectal Cancer Group - GEWF Procedure: The surgical resection specimen will be embedded in a plastic container with 1000 ml of GEWF solution for 24 to 48 hours. GEWF solution is a fixative composed of 62.5% ethanol, 21.25% distilled water, 10% formaldehyde and 6.25% glacial acetic acid. Following, a technician in pathological macroscopy with 10 years of experience will perform a visual and manual assessment of additional lymph nodes for 60 minutes. Each additional lymph node identified will be entirely or partially embedded, depending on the size, in paraffin and subsequently stained with hematoxylin-eosin. The microscopic examination of the slides obtained from the anatomopathological examination with Carnoy's solution will be performed by two pathologists with seven and 25 years of experience, respectively, both with wide experience in lymph node clearing technique.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Unplanned extended resection
  • Synchronous colorectal cancer
  • Inflammatory bowel disease
  • Extended lymphadenectomy

Treatment and study plan

Carnoy Solution

Procedure

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

GEWF Solution

Procedure

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

Primary outcomes

  1. Increased lymph node sample

    Time frame: 1 week

    Additional number (unit measure) of lymph nodes identified by the lymph node clearing technique (visual and manual examination with Carnoy's or GEWF solutions) compared to the initial number (unit measure) of lymph nodes identified by the conventional technique (visual and manual examination with formaldehyde).

Secondary outcomes

  1. Additional lymph node metastases

    Time frame: 1 week

    Presence of metastases in the additional lymph nodes harvested

  2. Change of lymph node staging

    Time frame: 1 week

    Increase of lymph node staging status (migration from N classification to higher staging), according to the 7th edition of the American Joint Committee on Cancer, with the lymph node clearing technique (visual and manual examination with Carnoy's or GEWF solutions) compared to the initial lymph node staging by the conventional technique (visual and manual examination with formaldehyde).

  3. Indication for adjuvant treatment

    Time frame: 1 month

    Patient (unit measure) who had indication for adjuvant treatment (chemotherapy, radiotherapy or combined chemoradiotharepy) to treat colorectal cancer due to the outcome changes of the lymph node staging after using the lymph node clearing technique (visual and manual examination with Carnoy's or GEWF solutions).

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Mar 10, 2016
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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