Rectal CancerNCT02629315
Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial
A study testing Carnoy's solution and 10% neutral buffered formaldehyde in people with Rectal Cancer and Gastric Adenocarcinoma, run by Instituto do Cancer do Estado de São Paulo.
Trial summary
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Gastric Adenocarcinoma
- What is being tested?
- Carnoy's solution and 10% neutral buffered formaldehyde
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2012to 10 Feb 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Long course neoadjuvant chemoradiation
- Low anterior resection with total mesorectal excision
- Rectosigmoidectomy
- Gastric adenocarcinoma
- Subtotal gastrectomy
- D2 lymphadenectomy
Who cannot join
- Previous surgery
- Incomplete neoadjuvant chemoradiation
- Refuse to sign the informed consent
- T4b and/or Multivisceral resection
- Previous surgery
- Neoadjuvant chemoradiation
Show all 12Show fewer
- Refuse to sign the informed consent
- T4b and/or Multivisceral resection
- Distant metastasis
- Previous upper abdomen radiotherapy
- Previous surgery over stomach or omentum
- Refuse to sign the informed consent
About this study
Official title: Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.
Read the detailed description
Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.
- Conditions
- Rectal Cancer, Gastric Adenocarcinoma
- Being tested
- Carnoy's solution, 10% neutral buffered formaldehyde
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carnoy's solutionOther
10% neutral buffered formaldehydeOther
| Study group | Role | What they receive |
|---|---|---|
| 10% neutral buffered formaldehyde | Active comparator | Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes. Receives: Other: 10% neutral buffered formaldehyde |
| Carnoy's solution | Experimental | Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes. Receives: Other: Carnoy's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node yield
Primary outcome will be the total number of lymph nodes dissected in each specimen
Measured: 10 days - accessed with the pathological report for each specimen
Secondary outcomes (1)
Dissection duration
Secondary outcome will be measured in minutes, counting from the start to the end of the dissection
Measured: 10 days - accessed with the pathological report for each specimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start10 May 2012
- Primary completion10 Feb 2014
- Study completion10 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Care provider
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629315
- Sponsor's protocol ID
- NP458/13
- Status last verified
- Jul 2020
- First submitted
- 10 Dec 2015
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dias AR, Pereira MA, Mello ES, Zilberstein B, Cecconello I, Ribeiro Junior U. Carnoy's solution increases the number of examined lymph nodes following gastrectomy for adenocarcinoma: a randomized trial. Gastric Cancer. 2016 Jan;19(1):136-42. doi: 10.1007/s10120-014-0443-2. Epub 2014 Nov 20.
PubMed 25410474Pereira MA, Dias AR, Faraj SF, Cirqueira Cdos S, Tomitao MT, Nahas SC, Ribeiro U Jr, de Mello ES. Carnoy's solution is an adequate tissue fixative for routine surgical pathology, preserving cell morphology and molecular integrity. Histopathology. 2015 Feb;66(3):388-97. doi: 10.1111/his.12532. Epub 2014 Nov 10.
PubMed 25307771Luz DA, Ribeiro U Jr, Chassot C, Collet E Silva Fde S, Cecconello I, Corbett CE. Carnoy's solution enhances lymph node detection: an anatomical dissection study in cadavers. Histopathology. 2008 Dec;53(6):740-2. doi: 10.1111/j.1365-2559.2008.03148.x. No abstract available.
PubMed 19076686Duldulao M, Booth C, Denham L, Choi A, Friedman G, Kazanjian K. Alcohol fat clearing increases lymph node yield after surgery for colorectal cancer. Am Surg. 2014 Oct;80(10):1054-8.
PubMed 25264659Scabini S, Montecucco F, Nencioni A, Zoppoli G, Sartini M, Rimini E, Massobrio A, De Marini L, Poggi A, Boaretto R, Romairone E, Ballestrero A, Ferrando V. The effect of preoperative chemoradiotherapy on lymph nodes harvested in TME for rectal cancer. World J Surg Oncol. 2013 Nov 18;11:292. doi: 10.1186/1477-7819-11-292.
PubMed 24246069Dias AR, Pereira MA, de Mello ES, Nahas SC, Cecconello I, Ribeiro U Jr. Lymph Node Yield After Neoadjuvant Chemoradiotherapy in Rectal Cancer Specimens: A Randomized Trial Comparing Two Fixatives. Dis Colon Rectum. 2018 Aug;61(8):888-896. doi: 10.1097/DCR.0000000000001097.
PubMed 29944580Dias AR, Pereira MA, Mello ES, Cecconello I, Ribeiro-Jr U, Nahas SC. CARNOY'S SOLUTION INCREASES LYMPH NODES COUNT IN COLON CANCER SPECIMENS WHEN COMPARED TO FORMALIN FIXATION: A RANDOMIZED TRIAL. Arq Bras Cir Dig. 2022 Jun 17;35:e1656. doi: 10.1590/0102-672020210002e1656. eCollection 2022.
PubMed 35730885
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02629315
- Acronym / sponsor ID
- NP458/13
- Conditions
- Rectal Cancer, Gastric Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 10 May 2012 (actual)
- Primary completion
- 10 Feb 2014 (actual)
- Study completion
- 10 Feb 2014 (actual)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.
Detailed description
Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10% neutral buffered formaldehyde | Active comparator | Other: 10% neutral buffered formaldehydeSpecimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes. |
| Carnoy's solution | Experimental | Other: Carnoy's solutionSpecimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Long course neoadjuvant chemoradiation
- Low anterior resection with total mesorectal excision
- Rectosigmoidectomy
- Gastric adenocarcinoma
- Subtotal gastrectomy
Key exclusion criteria (12 listed)
- Previous surgery
- Incomplete neoadjuvant chemoradiation
- Refuse to sign the informed consent
- T4b and/or Multivisceral resection
- Previous surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carnoy's solution | Other | Carnoy's solution |
| 10% neutral buffered formaldehyde | Other | 10% neutral buffered formaldehyde |
Primary outcome
Lymph node yield
Time frame: 10 days - accessed with the pathological report for each specimen
Primary outcome will be the total number of lymph nodes dissected in each specimen
1 secondary outcome
Dissection duration
Time frame: 10 days - accessed with the pathological report for each specimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Background: PubMed 25410474Dias AR, Pereira MA, Mello ES, Zilberstein B, Cecconello I, Ribeiro Junior U. Carnoy's solution increases the number of examined lymph nodes following gastrectomy for adenocarcinoma: a randomized trial. Gastric Cancer. 2016 Jan;19(1):136-42. doi: 10.1007/s10120-014-0443-2. Epub 2014 Nov 20.
- Background: PubMed 25307771Pereira MA, Dias AR, Faraj SF, Cirqueira Cdos S, Tomitao MT, Nahas SC, Ribeiro U Jr, de Mello ES. Carnoy's solution is an adequate tissue fixative for routine surgical pathology, preserving cell morphology and molecular integrity. Histopathology. 2015 Feb;66(3):388-97. doi: 10.1111/his.12532. Epub 2014 Nov 10.
- Background: PubMed 19076686Luz DA, Ribeiro U Jr, Chassot C, Collet E Silva Fde S, Cecconello I, Corbett CE. Carnoy's solution enhances lymph node detection: an anatomical dissection study in cadavers. Histopathology. 2008 Dec;53(6):740-2. doi: 10.1111/j.1365-2559.2008.03148.x. No abstract available.
- Background: PubMed 25264659Duldulao M, Booth C, Denham L, Choi A, Friedman G, Kazanjian K. Alcohol fat clearing increases lymph node yield after surgery for colorectal cancer. Am Surg. 2014 Oct;80(10):1054-8.
- Background: PubMed 24246069Scabini S, Montecucco F, Nencioni A, Zoppoli G, Sartini M, Rimini E, Massobrio A, De Marini L, Poggi A, Boaretto R, Romairone E, Ballestrero A, Ferrando V. The effect of preoperative chemoradiotherapy on lymph nodes harvested in TME for rectal cancer. World J Surg Oncol. 2013 Nov 18;11:292. doi: 10.1186/1477-7819-11-292.
- Background: PubMed 29944580Dias AR, Pereira MA, de Mello ES, Nahas SC, Cecconello I, Ribeiro U Jr. Lymph Node Yield After Neoadjuvant Chemoradiotherapy in Rectal Cancer Specimens: A Randomized Trial Comparing Two Fixatives. Dis Colon Rectum. 2018 Aug;61(8):888-896. doi: 10.1097/DCR.0000000000001097.
- Derived from this study: PubMed 35730885Dias AR, Pereira MA, Mello ES, Cecconello I, Ribeiro-Jr U, Nahas SC. CARNOY'S SOLUTION INCREASES LYMPH NODES COUNT IN COLON CANCER SPECIMENS WHEN COMPARED TO FORMALIN FIXATION: A RANDOMIZED TRIAL. Arq Bras Cir Dig. 2022 Jun 17;35:e1656. doi: 10.1590/0102-672020210002e1656. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Carnoy's solution and 10% neutral buffered formaldehyde in people with Rectal Cancer and Gastric Adenocarcinoma, run by Instituto do Cancer do Estado de São Paulo.
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 6 inclusion and 12 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Lymph node yield (time frame: 10 days - accessed with the pathological report for each specimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02629315, which also lists 7 linked publications.
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 23 Jul 2020.