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

Instituto do Cancer do Estado de São Paulo

Status: Completed

Conditions: Gastric Adenocarcinoma; Rectal Cancer

Treatments: Other: 10% neutral buffered formaldehyde; Other: Carnoy's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02629315

NP458/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

10% neutral buffered formaldehyde

Active Comparator group

Description:

Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes.

Treatment:

Other: 10% neutral buffered formaldehyde

Carnoy's solution

Experimental group

Description:

Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes.

Treatment:

Other: Carnoy's solution