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Clinical Trial Comparing Carnoy's and GEWF Solutions

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ClinicalTrials.gov Identifier: NCT02704988
Recruitment Status : Completed
First Posted : March 10, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymph Node Metastasis Colorectal Cancer Procedure: Carnoy Solution Procedure: GEWF Solution Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer
Study Start Date : March 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Colon Cancer - Carnoy
(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.
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

Active Comparator: Colon Cancer - GEWF
(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.
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

Active Comparator: Rectal Cancer - Carnoy
(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.
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

Active Comparator: Rectal Cancer - GEWF
(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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Unplanned extended resection
  • Synchronous colorectal cancer
  • Inflammatory bowel disease
  • Extended lymphadenectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704988


Locations
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Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande Do Sul, Brazil, 90035001
Sponsors and Collaborators
Hospital Moinhos de Vento
Investigators
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Study Chair: Antonio N Kalil, MD, PhD Federal University of Health Science of Porto Alegre

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Responsible Party: Hospital Moinhos de Vento
ClinicalTrials.gov Identifier: NCT02704988     History of Changes
Other Study ID Numbers: HMV-CRC1
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmaceutical Solutions