Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02641925
• Other study ID #: 2015-07-010
• Secondary ID: KSWEET-02
• Status: Recruiting
• Phase: N/A
• First received: December 24, 2015
• Last updated: May 31, 2017
• Start date: August 2015
• Est. completion date: August 2020

Study information

• Verified date: May 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: Seung Wan Ryu, M.D., Ph.D.
• Phone: 82-53-250-7322
• Email: gsman[@]dsmc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.

Description:

The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed adenocarcinoma in stomach

• Aged=20 years and =80 years

• Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)

• Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria

• ECOG 0 (Eastern Cooperative Oncology Group)

• ASA score class I-III (American Society of Anesthesiologists)

• patient has given their written informed consent to participate in the study

Exclusion Criteria:

• Simultaneously combined resection of other organ

• Active other malignancy

• Expected to severe intra-abdominal adhesion due to previous abdominal operation history

• Uncontrolled co-morbidity

• Vulnerable patients

Related Conditions & MeSH terms

• Gastric Cancer
• Metabolic Syndrome
• Metabolic Syndrome X
• Stomach Neoplasms
• Syndrome

Intervention

Procedure:
• Omentum preserving
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
• Total omentectomy
Whole omentum will be removed during gastrectomy with lymph node dissection.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do

Sponsors (3)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center	Chonnam National University Hospital, Dong-A University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

An JY, Kim YM, Yun MA, Jeon BH, Noh SH. Improvement of type 2 diabetes mellitus after gastric cancer surgery: short-term outcome analysis after gastrectomy. World J Gastroenterol. 2013 Dec 28;19(48):9410-7. doi: 10.3748/wjg.v19.i48.9410. — View Citation

Herrera MF, Pantoja JP, Velázquez-Fernández D, Cabiedes J, Aguilar-Salinas C, García-García E, Rivas A, Villeda C, Hernández-Ramírez DF, Dávila A, Zaraín A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833. — View Citation

Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim ÉA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030. — View Citation

Lottati M, Kolka CM, Stefanovski D, Kirkman EL, Bergman RN. Greater omentectomy improves insulin sensitivity in nonobese dogs. Obesity (Silver Spring). 2009 Apr;17(4):674-80. doi: 10.1038/oby.2008.642. Epub 2009 Feb 12. — View Citation

Sdralis E, Argentou M, Mead N, Kehagias I, Alexandridis T, Kalfarentzos F. A prospective randomized study comparing patients with morbid obesity submitted to sleeve gastrectomy with or without omentectomy. Obes Surg. 2013 Jul;23(7):965-71. doi: 10.1007/s11695-013-0925-z. — View Citation

Tchernof A, Després JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011. Review. — View Citation

Thörne A, Lönnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR change	HOMA-IR change after operation	pre-operative and post-operative 12months
Secondary	prevalence of metabolic syndrome	check the presence of metabolic syndrome	pre-operative and post-operative 12months
Secondary	Complication	short-term any complication related to surgery	within 30days
Secondary	HOMA-IR change according to anastomosis type	comparison between Billoth-II and Roux-en-Y	pre-operative and post-operative 12months