Carnoy`s Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial

Rectal Cancer Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629315
• Other study ID #: NP458/13
• Status: Completed
• Phase: N/A
• Start date: May 10, 2012
• Est. completion date: February 10, 2014

Study information

• Verified date: July 2020
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 10, 2014
• Est. primary completion date: February 10, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma
• Rectal Cancer

Intervention

Other:
• Carnoy's solution

• 10% neutral buffered formaldehyde

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph node yield	Primary outcome will be the total number of lymph nodes dissected in each specimen	10 days - accessed with the pathological report for each specimen
Secondary	Dissection duration	Secondary outcome will be measured in minutes, counting from the start to the end of the dissection	10 days - accessed with the pathological report for each specimen