Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Oncology, Hungary | OTHER |
| University of Pecs | OTHER |
| Uzsoki Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total omentectomy | No Intervention | Total or subtotal gastrectomy with D2 lymphadenectomy and total omentectomy. | |
| Partial omentectomy | Experimental | Total or subtotal gastrectomy with D2 lymphadenectomy and partial omentectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial omentectomy | Procedure | Partial omentectomy: with preservation of the greater omentum at >2 cm from the gastroepiploic arcade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications (Clavien - Dindo classification) and morbidity | Incidence of 30 days postoperative morbidity (Clavien - Dindo classification). | 30 days |
| Postoperative immunological changes (Interleukin monitoring) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Data | Patient age, sex, BMI, etc. | 1 week |
| Surgical Data | Duration of the operation, type of the operation (laparoscopic or open), intraoperative blood loss, etc. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dezső Tóth | Contact | +36 (52) 411 - 717 | 55316 | dr.toth.dezso@med.unideb.hu |
| Péter Kolozsi | Contact | +36 (52) 411 - 717 | 55423 | kolozsi.peter@med.unideb.hu |
| Name | Affiliation | Role |
|---|---|---|
| Dezső Tóth | University of Debrecen - Surgical Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Debrecen - Surgical Clinic | Recruiting | Debrecen | Hajdú-Bihar | 4033 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22207307 | Background | 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. | |
| 31987046 | Background | 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. |
| Label | URL |
|---|---|
| World Health Organisation (WHO) International Agency for Research on Cancer - Stomach | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the pre-and postoperative interleukin blood levels to monitoring the immunological answer after total or partial omentectomy.
| 30 days |
| 1 week |
| Histopathological Data | Type of the tumor, TNM stadium, positive resection border, etc. | 1 month |
| Duration of the hospital stay | The time from the date of operation to the date of discharge. | 1 month |
| 18536863 | Background | 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. |
| 22028160 | Background | 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. |
| 27550526 | Background | 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. |
| 24669875 | Background | 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. |
| 32060757 | Background | 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. |
| D005767 |
| Gastrointestinal Diseases |
| D013272 | Stomach Diseases |