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

Primary Purpose

Rectal Cancer, Gastric Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carnoy's solution
10% neutral buffered formaldehyde
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    10% neutral buffered formaldehyde

    Carnoy's solution

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Lymph node yield
    Primary outcome will be the total number of lymph nodes dissected in each specimen

    Secondary Outcome Measures

    Dissection duration
    Secondary outcome will be measured in minutes, counting from the start to the end of the dissection

    Full Information

    First Posted
    December 10, 2015
    Last Updated
    July 21, 2020
    Sponsor
    Instituto do Cancer do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02629315
    Brief Title
    Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 10, 2012 (Actual)
    Primary Completion Date
    February 10, 2014 (Actual)
    Study Completion Date
    February 10, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto do Cancer do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer, Gastric Adenocarcinoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    Randomization occurred after surgery, the surgeon was blind during the procedure
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    10% neutral buffered formaldehyde
    Arm Type
    Active Comparator
    Arm Description
    Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes.
    Arm Title
    Carnoy's solution
    Arm Type
    Experimental
    Arm Description
    Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes.
    Intervention Type
    Other
    Intervention Name(s)
    Carnoy's solution
    Intervention Type
    Other
    Intervention Name(s)
    10% neutral buffered formaldehyde
    Primary Outcome Measure Information:
    Title
    Lymph node yield
    Description
    Primary outcome will be the total number of lymph nodes dissected in each specimen
    Time Frame
    10 days - accessed with the pathological report for each specimen
    Secondary Outcome Measure Information:
    Title
    Dissection duration
    Description
    Secondary outcome will be measured in minutes, counting from the start to the end of the dissection
    Time Frame
    10 days - accessed with the pathological report for each specimen

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25410474
    Citation
    Dias AR, Pereira MA, Mello ES, Zilberstein B, Cecconello I, Ribeiro Junior U. Carnoy's solution increases the number of examined lymph nodes following gastrectomy for adenocarcinoma: a randomized trial. Gastric Cancer. 2016 Jan;19(1):136-42. doi: 10.1007/s10120-014-0443-2. Epub 2014 Nov 20.
    Results Reference
    background
    PubMed Identifier
    25307771
    Citation
    Pereira MA, Dias AR, Faraj SF, Cirqueira Cdos S, Tomitao MT, Nahas SC, Ribeiro U Jr, de Mello ES. Carnoy's solution is an adequate tissue fixative for routine surgical pathology, preserving cell morphology and molecular integrity. Histopathology. 2015 Feb;66(3):388-97. doi: 10.1111/his.12532. Epub 2014 Nov 10.
    Results Reference
    background
    PubMed Identifier
    19076686
    Citation
    Luz DA, Ribeiro U Jr, Chassot C, Collet E Silva Fde S, Cecconello I, Corbett CE. Carnoy's solution enhances lymph node detection: an anatomical dissection study in cadavers. Histopathology. 2008 Dec;53(6):740-2. doi: 10.1111/j.1365-2559.2008.03148.x. No abstract available.
    Results Reference
    background
    PubMed Identifier
    25264659
    Citation
    Duldulao M, Booth C, Denham L, Choi A, Friedman G, Kazanjian K. Alcohol fat clearing increases lymph node yield after surgery for colorectal cancer. Am Surg. 2014 Oct;80(10):1054-8.
    Results Reference
    background
    PubMed Identifier
    24246069
    Citation
    Scabini S, Montecucco F, Nencioni A, Zoppoli G, Sartini M, Rimini E, Massobrio A, De Marini L, Poggi A, Boaretto R, Romairone E, Ballestrero A, Ferrando V. The effect of preoperative chemoradiotherapy on lymph nodes harvested in TME for rectal cancer. World J Surg Oncol. 2013 Nov 18;11:292. doi: 10.1186/1477-7819-11-292.
    Results Reference
    background
    PubMed Identifier
    29944580
    Citation
    Dias AR, Pereira MA, de Mello ES, Nahas SC, Cecconello I, Ribeiro U Jr. Lymph Node Yield After Neoadjuvant Chemoradiotherapy in Rectal Cancer Specimens: A Randomized Trial Comparing Two Fixatives. Dis Colon Rectum. 2018 Aug;61(8):888-896. doi: 10.1097/DCR.0000000000001097.
    Results Reference
    background
    PubMed Identifier
    35730885
    Citation
    Dias AR, Pereira MA, Mello ES, Cecconello I, Ribeiro-Jr U, Nahas SC. CARNOY'S SOLUTION INCREASES LYMPH NODES COUNT IN COLON CANCER SPECIMENS WHEN COMPARED TO FORMALIN FIXATION: A RANDOMIZED TRIAL. Arq Bras Cir Dig. 2022 Jun 17;35:e1656. doi: 10.1590/0102-672020210002e1656. eCollection 2022.
    Results Reference
    derived

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

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