NCT02641925

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

December 24, 2015

Last Update Submit

May 31, 2017

Conditions

Metabolic SyndromeGastric Cancer

Keywords

Metabolic syndromegastric canceromentectomy

Outcome Measures

Primary Outcomes (1)

  • HOMA-IR change

    HOMA-IR change after operation

    pre-operative and post-operative 12months

Secondary Outcomes (3)

  • prevalence of metabolic syndrome

    pre-operative and post-operative 12months

  • Complication

    within 30days

  • HOMA-IR change according to anastomosis type

    pre-operative and post-operative 12months

Study Arms (2)

Omentum preserving

ACTIVE COMPARATOR

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

Procedure: Omentum preserving

Total omentectomy

EXPERIMENTAL

Total omentectomy: Whole omentum will be removed.

Procedure: Total omentectomy

Interventions

Omentum preservingPROCEDURE

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

Omentum preserving
Total omentectomyPROCEDURE

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

Total omentectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-809, South Korea

RECRUITING

Dong-A University Hospital

Busan, 602-715, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

RECRUITING

Related 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.

    PMID: 24409070BACKGROUND

  • 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.

    PMID: 23404948BACKGROUND

  • 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.

    PMID: 19214178BACKGROUND

  • 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.

    PMID: 23526069BACKGROUND

  • 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.

    PMID: 23303913BACKGROUND

  • 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.

    PMID: 11850750BACKGROUND

  • 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.

    PMID: 20587720BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeStomach Neoplasms

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Seung Wan Ryu, M.D., Ph.D.

    Korean South West East Gastric Surgery Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-53-250-7322gsman@dsmc.or.kr

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
Director of Gastrointesinal surgery, associate professor

Study Record Dates

First Submitted

December 24, 2015

First Posted

December 30, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

June 1, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

Locations

KR(3)