Total Versus Partial Omentectomy in the Treatment of Gastric Cancer (TOPO)

May 16, 2022 updated by: Dezso Toth, University of Debrecen

A Multicenter, Prospective, Randomized Trial to Evaluate the Role of Total Versus Partial Omentectomy in the Treatment of Tis - T3 Gastric Cancer.

The main purpose of this study is to evaluate the role of the type of omentectomy (partial or total) in the treatment of Tis - T3 gastric cancer without serosal infiltration. The second purpose is to monitoring the blood levels of immunological factors (interleukins, T cell subtypes, etc.) pre-and postoperatively, depending on the type of omentectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is the second common tumor type. In 2020, the incidence of gastric cancer was over one million and caused about 770 000 tumor-associated deaths worldwide. Although the improvement of the perioperative oncological therapy is unquestionable, the major point of the treatment is radical surgical intervention. Laparoscopic technic is widespread in the treatment of gastric cancer, too. For the oncological radicality total or subtotal gastrectomy with D2 omentectomy is necessary, but the opinions are divided about the role of the omentectomy. Total omentectomy in laparoscopic operations takes more time and increases the postoperative morbidity, blood loss, and opportunity of the anastomosis insufficiency, and the incidence of the omental metastases is just between 3,8 - 5%. Based on this, many international guidelines allow partial omentectomy in early gastric cancer. At the same time, in advanced gastric neoplasm, the place of the partial omentectomy is still unclear.

With this prospective, randomized, multicentric study we plan to compare the total and partial omentectomy in the surgery of Tis - T3 gastric cancer with the analysis of the postoperative morbidity and mortality and long-term survival factors.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
    • Hajdú - Bihar
      • Debrecen, Hajdú - Bihar, Hungary, 4033
        • Recruiting
        • University of Debrecen - Surgical Clinic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dezső Tóth
        • Sub-Investigator:
          • Péter Kolozsi

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:

  • American Society of Anesthesiologists (ASA) I-III., Karnofsky Performance Score (KPS) >60, Eastern Cooperative Oncology Group (ECOG) 0-1
  • Tis-T3 gastric cancer without serosal infiltration and treated with the radical operation (R0; D2 lymphadenectomy, lymph nodes >16)
  • clinical stadium: Tis-3; M0
  • written informed consent provided
  • good patient compliance
  • no previous chemotherapy or irradiation

Exclusion Criteria:

  • serosal infiltration and/or distant metastasis, omental infiltration, peritoneal carcinosis, positive abdominal cytological lavage
  • organ transplantation and/or immunological disease and/or immunomodulation therapy
  • another primary tumor
  • decompensated chronic disease (for example: liver cirrhosis with ascites, kidney failure treated with hemodialysis, New York Heart Association (NYHA) IV. cardiac status, etc.)
  • unsuccessful follow-up

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Total omentectomy
Total or subtotal gastrectomy with D2 lymphadenectomy and total omentectomy.
Experimental: Partial omentectomy
Total or subtotal gastrectomy with D2 lymphadenectomy and partial omentectomy.
Procedure: Partial omentectomy
Partial omentectomy: with preservation of the greater omentum at >2 cm from the gastroepiploic arcade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3y Overall Surveillance
Time Frame: 3 years
Duration from the operation to the date of death.
3 years
3y Disease Free Surveillance
Time Frame: 3 years
Duration from the operation to the date of radiological or histological proven relapse.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complications (Clavien - Dindo classification) and morbidity
Time Frame: 30 days
Incidence of 30 days postoperative morbidity (Clavien - Dindo classification).
30 days
Postoperative immunological changes (Interleukin monitoring)
Time Frame: 30 days
Compare the pre-and postoperative interleukin blood levels to monitoring the immunological answer after total or partial omentectomy.
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Data
Time Frame: 1 week
Patient age, sex, BMI, etc.
1 week
Surgical Data
Time Frame: 1 week
Duration of the operation, type of the operation (laparoscopic or open), intraoperative blood loss, etc.
1 week
Histopathological Data
Time Frame: 1 month
Type of the tumor, TNM stadium, positive resection border, etc.
1 month
Duration of the hospital stay
Time Frame: 1 month
The time from the date of operation to the date of discharge.
1 month

Collaborators and Investigators

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

Sponsor

University of Debrecen

Collaborators

University of Pecs
National Institute of Oncology, Hungary
Uzsoki Street Hospital, Hungary

Investigators

  • Study Chair: Dezső Tóth, University of Debrecen - Surgical Clinic

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

Helpful Links

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)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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