Digestive System Neoplasm, Gastric Cancer, Interleukin, Stomach Cancer, Stomach Neoplasms
Conditions
Keywords
gastric cancer, total omentectomy, partial omentectomy, stomach cancer, interleukin, immunological answer
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.
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.
Interventions
PROCEDUREPartial omentectomy
Partial omentectomy: with preservation of the greater omentum at \>2 cm from the gastroepiploic arcade.
Sponsors
National Institute of Oncology, Hungary
University of Pecs
Uzsoki Hospital
University of Debrecen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hungary
Contacts
Primary ContactDezső Tóth
Backup ContactPéter Kolozsi
Outcome results
None listed