Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

Gastric Cancer Clinical Trial

— TOPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05238584
• Other study ID #: TOPO
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2022
• Source: University of Debrecen
• Contact: Dezso Tóth
• Phone: +36 (52) 411 - 717
• Email: dr.toth.dezso[@]med.unideb.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastric Cancer
• Gastrointestinal Neoplasms
• Interleukin
• Neoplasms
• Stomach Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Partial omentectomy
Partial omentectomy: with preservation of the greater omentum at >2 cm from the gastroepiploic arcade.

Locations

Country	Name	City	State
Hungary	University of Debrecen - Surgical Clinic	Debrecen	Hajdú - Bihar

Sponsors (4)

Lead Sponsor	Collaborator
University of Debrecen	National Institute of Oncology, Hungary, University of Pecs, Uzsoki Street Hospital, Hungary

Country where clinical trial is conducted

Hungary, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Data	Patient age, sex, BMI, etc.	1 week
Other	Surgical Data	Duration of the operation, type of the operation (laparoscopic or open), intraoperative blood loss, etc.	1 week
Other	Histopathological Data	Type of the tumor, TNM stadium, positive resection border, etc.	1 month
Other	Duration of the hospital stay	The time from the date of operation to the date of discharge.	1 month
Primary	3y Overall Surveillance	Duration from the operation to the date of death.	3 years
Primary	3y Disease Free Surveillance	Duration from the operation to the date of radiological or histological proven relapse.	3 years
Secondary	Postoperative Complications (Clavien - Dindo classification) and morbidity	Incidence of 30 days postoperative morbidity (Clavien - Dindo classification).	30 days
Secondary	Postoperative immunological changes (Interleukin monitoring)	Compare the pre-and postoperative interleukin blood levels to monitoring the immunological answer after total or partial omentectomy.	30 days

External Links

•   World Health Organisation (WHO) International Agency for Research on Cancer - Stomach