TOPO: Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

Sponsor

University of Debrecen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05238584

Collaborator

National Institute of Oncology, Hungary (Other), University of Pecs (Other), Uzsoki Street Hospital, Hungary (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms Interleukin Stomach Cancer Gastric Cancer Digestive System Neoplasm	Procedure: Partial omentectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

3y Overall Surveillance [3 years]
Duration from the operation to the date of death.
3y Disease Free Surveillance [3 years]
Duration from the operation to the date of radiological or histological proven relapse.

Secondary Outcome Measures

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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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