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

Instituto do Cancer do Estado de São Paulo130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

130

Conditions

Rectal Cancer Gastric Adenocarcinoma

Interventions

Carnoy's solutionOTHER

10% neutral buffered formaldehydeOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Lymph node yield

Primary outcome will be the total number of lymph nodes dissected in each specimen

Time frame: 10 days - accessed with the pathological report for each specimen

Secondary Outcomes

Dissection duration

Secondary outcome will be measured in minutes, counting from the start to the end of the dissection

Time frame: 10 days - accessed with the pathological report for each specimen

Data from ClinicalTrials.gov

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