Clinical trial NCT02629315: Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Gastric Adenocarcinoma
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2015-12-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria - Rectal Cancer:

* Long course neoadjuvant chemoradiation
* Low anterior resection with total mesorectal excision

Inclusion Criteria - Colon Cancer:

- Rectosigmoidectomy

Inclusion Criteria - Gastric Cancer:

* Gastric adenocarcinoma
* Subtotal gastrectomy
* D2 lymphadenectomy

Exclusion Criteria - Rectal Cancer:

* Previous surgery
* Incomplete neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

Exclusion Criteria - Colon Cancer:

* Previous surgery
* Neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

Exclusion Criteria - Gastric Cancer:

* Distant metastasis
* Previous upper abdomen radiotherapy
* Previous surgery over stomach or omentum
* Refuse to sign the informed consent

Primary outcomes:
measure: Lymph node yield
timeFrame: 10 days - accessed with the pathological report for each specimen
Secondary outcomes:
measure: Dissection duration
timeFrame: 10 days - accessed with the pathological report for each specimen
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Pereira 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.
citation: Luz 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.
citation: Duldulao 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.
citation: Scabini 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.
citation: Dias 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.
citation: Dias 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.