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

Not Applicable

Completed

• Conditions: Gastric Adenocarcinoma; Rectal Cancer
• Interventions: Other: 10% neutral buffered formaldehyde; Other: Carnoy's solution

• Registration Number: NCT02629315
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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.

Study Timeline

• Study Start: 2012-05-10
• Primary Completion: 2014-02-10
• Study Completion: 2014-02-10
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-14
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10% neutral buffered formaldehyde	10% neutral buffered formaldehyde	Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes.
Carnoy's solution	Carnoy's solution	Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes.

Primary Outcome Measures

Name	Time	Method
Lymph node yield	10 days - accessed with the pathological report for each specimen	Primary outcome will be the total number of lymph nodes dissected in each specimen

Secondary Outcome Measures

Name	Time	Method
Dissection duration	10 days - accessed with the pathological report for each specimen	Secondary outcome will be measured in minutes, counting from the start to the end of the dissection