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Status unknownNCT02641925Updated Jun 1, 2017

Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

An interventional study of Omentum preserving and Total omentectomy in Metabolic Syndrome and Gastric Cancer, sponsored by Keimyung University Dongsan Medical Center. Status unknown at 3 sites in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-06-01.

Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Metabolic Syndrome
  • Gastric Cancer

Keywords

  • Metabolic syndrome
  • gastric cancer
  • omentectomy
03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 60 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Omentum preserving

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

    Procedure: Omentum preserving

  • Experimental
    Total omentectomy

    Total omentectomy: Whole omentum will be removed.

    Procedure: Total omentectomy

Interventions

  • ProcedureOmentum preserving

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

  • ProcedureTotal omentectomy

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

06

What researchers measure

Primary outcomes

  1. HOMA-IR change

    HOMA-IR change after operation

    Time frame: pre-operative and post-operative 12months

Secondary outcomes

  1. prevalence of metabolic syndrome

    check the presence of metabolic syndrome

    Time frame: pre-operative and post-operative 12months

  2. Complication

    short-term any complication related to surgery

    Time frame: within 30days

  3. HOMA-IR change according to anastomosis type

    comparison between Billoth-II and Roux-en-Y

    Time frame: pre-operative and post-operative 12months

07

Study locations

3 of 3 sites recruiting
  • Chonnam National University Hwasun Hospital
    Hwasun, Jeollanam-do 519-809, Korea, Republic of
    • Young Kyu Park, MD, PhD · Contact
    • Seong Yeop Ryu, MD, PhD · Sub investigator
    • Jeong Oh, MD, PhD · Sub investigator
    • Mi Ran Jung, MD, PhD · Sub investigator
    Recruiting
  • Dong-A University Hospital
    Busan, 602-715, Korea, Republic of
    • Min Chan Kim, MD, PhD · Contact
    • Min Chan Kim, MD, PhD · Principal investigator
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, 700-712, Korea, Republic of
    • Seung Wan Ryu, MD, PhD · Contact · gsman@dsmc.or.kr · 82-53-250-7322
    • In Gyu Kwon, MD · Contact · surgeon@dsmc.or.kr · 82-53-250-7322
    • Seung Wan Ryu, MD, PhD · Principal investigator
    • In Gyu Kwon, MD · Sub investigator
    • Young Gil Son, MD, PhD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24409070 ↗
  • 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. PubMed 23404948 ↗
  • 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. PubMed 19214178 ↗
  • 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. PubMed 23526069 ↗
  • 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. PubMed 23303913 ↗
  • 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. PubMed 11850750 ↗
  • 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. PubMed 20587720 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02641925
Lead sponsor
Keimyung University Dongsan Medical Center
Collaborators
Chonnam National University Hospital, Dong-A University Hospital
Responsible party
Seung Wan Ryu (Director of Gastrointesinal surgery, associate professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Dec 30, 2015
Start date
Aug 2015
Primary completion
Aug 2019 (estimated)
Completion
Aug 2020 (estimated)
Last update
Jun 1, 2017

Study contacts

Seung Wan Ryu, M.D., Ph.D.
Contact
gsman@dsmc.or.kr
82-53-250-7322
Seung Wan Ryu, M.D., Ph.D.
principal investigator · Korean South West East Gastric Surgery Group

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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