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

July 21, 2020 updated by: Instituto do Cancer do Estado de São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 10% neutral buffered formaldehyde
Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes.
Other: 10% neutral buffered formaldehyde
EXPERIMENTAL: Carnoy's solution
Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes.
Other: Carnoy's solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph node yield
Time Frame: 10 days - accessed with the pathological report for each specimen
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dissection duration
Time Frame: 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
10 days - accessed with the pathological report for each specimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cancer do Estado de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2012

Primary Completion (ACTUAL)

February 10, 2014

Study Completion (ACTUAL)

February 10, 2014

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (ESTIMATE)

December 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP458/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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