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Lymph Node MetastasisNCT02704988

Clinical Trial Comparing Carnoy's and GEWF Solutions

A study testing Carnoy Solution and GEWF Solution in people with Lymph Node Metastasis and Colorectal Cancer, run by Hospital Moinhos de Vento at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymph Node Metastasis, Colorectal Cancer
What is being tested?
Carnoy Solution and GEWF Solution
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
1 siteBrazil
Study dates
Mar 2015to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Absence of accurate histopathological data
  • Unplanned extended resection
  • Synchronous colorectal cancer
  • Inflammatory bowel disease
  • Extended lymphadenectomy

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035001

Other trials in Brazil

About this study

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

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.

Read the 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
Being tested
Carnoy Solution, GEWF Solution
Medical subject headings
Lymphatic Metastasis, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carnoy SolutionProcedure or surgery

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

  • GEWF SolutionProcedure or surgery

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

Study groups in NCT02704988
Study groupRoleWhat they receive
Colon Cancer - CarnoyActive comparator(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.
Receives: Procedure: Carnoy Solution
Colon Cancer - GEWFActive comparator(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.
Receives: Procedure: GEWF Solution
Rectal Cancer - CarnoyActive comparator(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.
Receives: Procedure: Carnoy Solution
Rectal Cancer - GEWFActive comparator(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.
Receives: Procedure: GEWF Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increased lymph node sample

    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).

    Measured: 1 week

Secondary outcomes (3)
  1. Additional lymph node metastases

    Presence of metastases in the additional lymph nodes harvested

    Measured: 1 week

  2. Change of lymph node staging

    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).

    Measured: 1 week

  3. Indication for adjuvant treatment

    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).

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2016 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02704988
Sponsor's protocol ID
HMV-CRC1
Status last verified
Mar 2019
First submitted
22 Feb 2016
Last updated
20 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Carnoy Solution and GEWF Solution in people with Lymph Node Metastasis and Colorectal Cancer, run by Hospital Moinhos de Vento at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased lymph node sample (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.

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