- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704988
Clinical Trial Comparing Carnoy's and GEWF Solutions
Clinical Trial Comparing Carnoy's and GEWF Solutions for Lymph Node Clearing Technique in Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035001
- Hospital Moinhos de Vento
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with Carnoy solution
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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.
|
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.
|
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.
|
The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with GEWF solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional lymph node metastases
Time Frame: 1 week
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Presence of metastases in the additional lymph nodes harvested
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1 week
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Change of lymph node staging
Time Frame: 1 week
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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).
|
1 week
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Indication for adjuvant treatment
Time Frame: 1 month
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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).
|
1 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Antonio N Kalil, MD, PhD, Federal University of Health Science of Porto Alegre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Colorectal Neoplasms
- Lymphatic Metastasis
- Pharmaceutical Solutions
Other Study ID Numbers
- HMV-CRC1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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