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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-10

Study Completion Date

2014-02-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

NCT00682786

Rectal Carcinoma

COMPLETED PHASE2

Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites

NCT04267575

Recurrent Malignant Solid Neoplasm Stage IV Breast Cancer Stage IV Prostate Cancer +13 more

UNKNOWN NA

Sentinel Lymph Node Mapping in Rectal Cancer

NCT02869152

Rectal Neoplasms

UNKNOWN NA

Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

NCT04816045

Colorectal Cancer

UNKNOWN PHASE1/PHASE2

Studying Biomarkers in Tumor Tissue and Blood Samples From Patients Undergoing Chemotherapy and Radiation Therapy for Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

NCT00960427

Colorectal Cancer

WITHDRAWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rectal Cancer Gastric Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

10% neutral buffered formaldehyde

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

Group Type ACTIVE_COMPARATOR

10% neutral buffered formaldehyde

Intervention Type OTHER

Carnoy's solution

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

Group Type EXPERIMENTAL

Carnoy's solution

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carnoy's solution

Intervention Type OTHER

10% neutral buffered formaldehyde

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Long course neoadjuvant chemoradiation
* Low anterior resection with total mesorectal excision

\- Rectosigmoidectomy

* Gastric adenocarcinoma
* Subtotal gastrectomy
* D2 lymphadenectomy

Exclusion Criteria

* Previous surgery
* Incomplete neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

* Previous surgery
* Neoadjuvant chemoradiation
* Refuse to sign the informed consent
* T4b and/or Multivisceral resection

* Distant metastasis
* Previous upper abdomen radiotherapy
* Previous surgery over stomach or omentum
* Refuse to sign the informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No