Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

Last updated: May 16, 2022
Sponsor: University of Debrecen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stomach Cancer

Gastrointestinal Diseases And Disorders

Gastric Ulcers

Treatment

N/A

Clinical Study ID

NCT05238584
TOPO
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 radicaloperation (R0; D2 lymphadenectomy, lymph nodes >16)
  • clinical stadium: Tis-3; M0
  • written informed consent provided
  • good patient compliance
  • no previous chemotherapy or irradiation

Exclusion

Exclusion Criteria:

  • serosal infiltration and/or distant metastasis, omental infiltration, peritonealcarcinosis, 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, kidneyfailure treated with hemodialysis, New York Heart Association (NYHA) IV. cardiacstatus, etc.)
  • unsuccessful follow-up

Study Design

Total Participants: 300
Study Start date:
January 01, 2022
Estimated Completion Date:
July 01, 2024

Study 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.

Connect with a study center

  • University of Debrecen - Surgical Clinic

    Debrecen, Hajdú - Bihar 4033
    Hungary

    Active - Recruiting

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