Gastric Cancer Clinical Trial
— TOPOOfficial title:
A Multicenter, Prospective, Randomized Trial to Evaluate the Role of Total Versus Partial Omentectomy in the Treatment of Tis - T3 Gastric Cancer.
NCT number | NCT05238584 |
Other study ID # | TOPO |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | July 1, 2024 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Hungary | University of Debrecen - Surgical Clinic | Debrecen | Hajdú - Bihar |
Lead Sponsor | Collaborator |
---|---|
University of Debrecen | National Institute of Oncology, Hungary, University of Pecs, Uzsoki Street Hospital, Hungary |
Hungary,
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
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 |
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