Clinical trial NCT05238584: Total Versus Partial Omentectomy in the Treatment of Gastric Cancer
Official title: A Multicenter, Prospective, Randomized Trial to Evaluate the Role of Total Versus Partial Omentectomy in the Treatment of Tis - T3 Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Interleukin
Stomach Cancer
Gastric Cancer
Digestive System Neoplasm
Keywords: gastric cancer
total omentectomy
partial omentectomy
stomach cancer
interleukin
immunological answer
Lead sponsor: University of Debrecen
Sponsor class: OTHER
Collaborators: name: National Institute of Oncology, Hungary
name: University of Pecs
name: Uzsoki Hospital
First posted: 2022-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 3y Overall Surveillance
timeFrame: 3 years
measure: 3y Disease Free Surveillance
timeFrame: 3 years
Secondary outcomes:
measure: Postoperative Complications (Clavien - Dindo classification) and morbidity
timeFrame: 30 days
measure: Postoperative immunological changes (Interleukin monitoring)
timeFrame: 30 days
Other outcomes:
measure: Patient Data
timeFrame: 1 week
measure: Surgical Data
timeFrame: 1 week
measure: Histopathological Data
timeFrame: 1 month
measure: Duration of the hospital stay
timeFrame: 1 month
Locations:
city: Debrecen
country: Hungary
facility: University of Debrecen - Surgical Clinic
state: Hajdú - Bihar
Study officials:
affiliation: University of Debrecen - Surgical Clinic
name: Dezső Tóth
role: STUDY_CHAIR
References:
citation: Hamabe A, Omori T, Tanaka K, Nishida T. Comparison of long-term results between laparoscopy-assisted gastrectomy and open gastrectomy with D2 lymph node dissection for advanced gastric cancer. Surg Endosc. 2012 Jun;26(6):1702-9. doi: 10.1007/s00464-011-2096-0. Epub 2011 Dec 30.
citation: Zeng F, Chen L, Liao M, Chen B, Long J, Wu W, Deng G. Laparoscopic versus open gastrectomy for gastric cancer. World J Surg Oncol. 2020 Jan 27;18(1):20. doi: 10.1186/s12957-020-1795-1.
citation: Ha TK, An JY, Youn HG, Noh JH, Sohn TS, Kim S. Omentum-preserving gastrectomy for early gastric cancer. World J Surg. 2008 Aug;32(8):1703-8. doi: 10.1007/s00268-008-9598-5.
citation: Kim MC, Kim KH, Jung GJ, Rattner DW. Comparative study of complete and partial omentectomy in radical subtotal gastrectomy for early gastric cancer. Yonsei Med J. 2011 Nov;52(6):961-6. doi: 10.3349/ymj.2011.52.6.961.
citation: Jongerius EJ, Boerma D, Seldenrijk KA, Meijer SL, Scheepers JJ, Smedts F, Lagarde SM, Balague Ponz O, van Berge Henegouwen MI, van Sandick JW, Gisbertz SS. Role of omentectomy as part of radical surgery for gastric cancer. Br J Surg. 2016 Oct;103(11):1497-503. doi: 10.1002/bjs.10149. Epub 2016 Aug 23.
citation: Kim DJ, Lee JH, Kim W. A comparison of total versus partial omentectomy for advanced gastric cancer in laparoscopic gastrectomy. World J Surg Oncol. 2014 Mar 26;12:64. doi: 10.1186/1477-7819-12-64.
citation: Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2018 (5th edition). Gastric Cancer. 2021 Jan;24(1):1-21. doi: 10.1007/s10120-020-01042-y. Epub 2020 Feb 14. No abstract available.