Total Versus Partial Omentectomy in the Treatment of Gastric Cancer

NCT ID: NCT05238584

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-07-01

Brief Summary

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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

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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.

Conditions

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Stomach Neoplasms Interleukin Stomach Cancer Gastric Cancer Digestive System Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total omentectomy

Total or subtotal gastrectomy with D2 lymphadenectomy and total omentectomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Partial omentectomy

Total or subtotal gastrectomy with D2 lymphadenectomy and partial omentectomy.

Group Type EXPERIMENTAL

Partial omentectomy

Intervention Type PROCEDURE

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

Interventions

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Partial omentectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Oncology, Hungary

OTHER

Sponsor Role collaborator

University of Pecs

OTHER

Sponsor Role collaborator

Uzsoki Hospital

OTHER

Sponsor Role collaborator

University of Debrecen

OTHER

Sponsor Role lead

Responsible Party

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Dezso Toth

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dezső Tóth

Role: STUDY_CHAIR

University of Debrecen - Surgical Clinic

Locations

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University of Debrecen - Surgical Clinic

Debrecen, Hajdú-Bihar, Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Dezső Tóth

Role: CONTACT

+36 (52) 411 - 717 ext. 55316

Péter Kolozsi

Role: CONTACT

+36 (52) 411 - 717 ext. 55423

Facility Contacts

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Dezső Tóth

Role: primary

+36 (52) 411 - 717 ext. 55316

Role: backup

+36 (52) 411 - 717 ext. 55423

References

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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.

Reference Type BACKGROUND
PMID: 22207307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31987046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18536863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22028160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27550526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24669875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32060757 (View on PubMed)

Related Links

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https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf

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

Other Identifiers

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TOPO

Identifier Type: -

Identifier Source: org_study_id

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