Total Versus Partial Omentectomy in the Treatment of Gastric Cancer
TOPO
A Multicenter, Prospective, Randomized Trial to Evaluate the Role of Total Versus Partial Omentectomy in the Treatment of Tis - T3 Gastric Cancer.
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedMay 20, 2022
May 1, 2022
2 years
February 3, 2022
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
3y Overall Surveillance
Duration from the operation to the date of death.
3 years
3y Disease Free Surveillance
Duration from the operation to the date of radiological or histological proven relapse.
3 years
Secondary Outcomes (2)
Postoperative Complications (Clavien - Dindo classification) and morbidity
30 days
Postoperative immunological changes (Interleukin monitoring)
30 days
Other Outcomes (4)
Patient Data
1 week
Surgical Data
1 week
Histopathological Data
1 month
- +1 more other outcomes
Study Arms (2)
Total omentectomy
NO INTERVENTIONTotal or subtotal gastrectomy with D2 lymphadenectomy and total omentectomy.
Partial omentectomy
EXPERIMENTALTotal or subtotal gastrectomy with D2 lymphadenectomy and partial omentectomy.
Interventions
Partial omentectomy: with preservation of the greater omentum at \>2 cm from the gastroepiploic arcade.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Debrecenlead
- National Institute of Oncology, Hungarycollaborator
- University of Pecscollaborator
- Uzsoki Hospitalcollaborator
Study Sites (1)
University of Debrecen - Surgical Clinic
Debrecen, Hajdú-Bihar, 4033, Hungary
Related Publications (7)
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.
PMID: 22207307BACKGROUNDZeng 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.
PMID: 31987046BACKGROUNDHa 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.
PMID: 18536863BACKGROUNDKim 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.
PMID: 22028160BACKGROUNDJongerius 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.
PMID: 27550526BACKGROUNDKim 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.
PMID: 24669875BACKGROUNDJapanese 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.
PMID: 32060757BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dezső Tóth
University of Debrecen - Surgical Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
January 1, 2022
Primary Completion
December 31, 2023
Study Completion
July 1, 2024
Last Updated
May 20, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share