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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02629315

Enrollment

130

Registered

2015-12-14

Start date

2012-05-10

Completion date

2014-02-10

Last updated

2020-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Adenocarcinoma, Rectal Cancer

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.

Interventions

OTHERCarnoy's solution

OTHER10% neutral buffered formaldehyde

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Caregiver)

Masking description

Randomization occurred after surgery, the surgeon was blind during the procedure

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026