Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

NCT ID: NCT02641925

Last Updated: 2017-06-01

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Metabolic Syndrome Gastric Cancer

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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Omentum preserving

Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.

Group Type ACTIVE_COMPARATOR

Omentum preserving

Intervention Type PROCEDURE

The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.

Total omentectomy

Total omentectomy: Whole omentum will be removed.

Group Type EXPERIMENTAL

Total omentectomy

Intervention Type PROCEDURE

Whole omentum will be removed during gastrectomy with lymph node dissection.

Interventions

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Omentum preserving

The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.

Intervention Type PROCEDURE

Total omentectomy

Whole omentum will be removed during gastrectomy with lymph node dissection.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chonnam National University Hospital

OTHER

Sponsor Role collaborator

Dong-A University Hospital

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seung Wan Ryu

Director of Gastrointesinal surgery, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seung Wan Ryu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korean South West East Gastric Surgery Group

Locations

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Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Site Status RECRUITING

Dong-A University Hospital

Busan, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Seung Wan Ryu, M.D., Ph.D.

Role: CONTACT

82-53-250-7322

Facility Contacts

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Young Kyu Park, MD, PhD

Role: primary

Min Chan Kim, MD, PhD

Role: primary

Seung Wan Ryu, MD, PhD

Role: primary

82-53-250-7322

In Gyu Kwon, MD

Role: backup

82-53-250-7322

References

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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.

Reference Type BACKGROUND
PMID: 24409070 (View on PubMed)

Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, 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.

Reference Type BACKGROUND
PMID: 23404948 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19214178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23526069 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23303913 (View on PubMed)

Thorne A, Lonnqvist 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. doi: 10.1038/sj.ijo.0801871.

Reference Type BACKGROUND
PMID: 11850750 (View on PubMed)

Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain 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.

Reference Type BACKGROUND
PMID: 20587720 (View on PubMed)

Other Identifiers

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KSWEET-02

Identifier Type: OTHER

Identifier Source: secondary_id

2015-07-010

Identifier Type: -

Identifier Source: org_study_id

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