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Completed

NCT Number: NCT02629315

Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: 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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carnoy's solution

Other

10% neutral buffered formaldehyde

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 14, 2015
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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