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Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

Primary Purpose

Metabolic Syndrome, Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omentum preserving
Total omentectomy
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic syndrome, gastric cancer, omentectomy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Omentum preserving

Total omentectomy

Arm Description

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

Total omentectomy: Whole omentum will be removed.

Outcomes

Primary Outcome Measures

HOMA-IR change
HOMA-IR change after operation

Secondary Outcome Measures

prevalence of metabolic syndrome
check the presence of metabolic syndrome
Complication
short-term any complication related to surgery
HOMA-IR change according to anastomosis type
comparison between Billoth-II and Roux-en-Y

Full Information

First Posted
December 24, 2015
Last Updated
May 31, 2017
Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Chonnam National University Hospital, Dong-A University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02641925
Brief Title
Omentectomy for Metabolic Syndrome in Gastric Cancer Patients
Official Title
The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
Collaborators
Chonnam National University Hospital, Dong-A University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Gastric Cancer
Keywords
Metabolic syndrome, gastric cancer, omentectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Omentum preserving
Arm Type
Active Comparator
Arm Description
Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed.
Arm Title
Total omentectomy
Arm Type
Experimental
Arm Description
Total omentectomy: Whole omentum will be removed.
Intervention Type
Procedure
Intervention Name(s)
Omentum preserving
Intervention Description
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
Intervention Type
Procedure
Intervention Name(s)
Total omentectomy
Intervention Description
Whole omentum will be removed during gastrectomy with lymph node dissection.
Primary Outcome Measure Information:
Title
HOMA-IR change
Description
HOMA-IR change after operation
Time Frame
pre-operative and post-operative 12months
Secondary Outcome Measure Information:
Title
prevalence of metabolic syndrome
Description
check the presence of metabolic syndrome
Time Frame
pre-operative and post-operative 12months
Title
Complication
Description
short-term any complication related to surgery
Time Frame
within 30days
Title
HOMA-IR change according to anastomosis type
Description
comparison between Billoth-II and Roux-en-Y
Time Frame
pre-operative and post-operative 12months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Wan Ryu, M.D., Ph.D.
Phone
82-53-250-7322
Email
gsman@dsmc.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, M.D., Ph.D.
Organizational Affiliation
Korean South West East Gastric Surgery Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
519-809
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Kyu Park, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seong Yeop Ryu, MD, PhD
First Name & Middle Initial & Last Name & Degree
Jeong Oh, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mi Ran Jung, MD, PhD
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Chan Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Min Chan Kim, MD, PhD
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, MD, PhD
Phone
82-53-250-7322
Email
gsman@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
In Gyu Kwon, MD
Phone
82-53-250-7322
Email
surgeon@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, MD, PhD
First Name & Middle Initial & Last Name & Degree
In Gyu Kwon, MD
First Name & Middle Initial & Last Name & Degree
Young Gil Son, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24409070
Citation
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.
Results Reference
background
PubMed Identifier
23404948
Citation
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.
Results Reference
background
PubMed Identifier
19214178
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.
Results Reference
background
PubMed Identifier
23526069
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.
Results Reference
background
PubMed Identifier
23303913
Citation
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.
Results Reference
background
PubMed Identifier
11850750
Citation
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.
Results Reference
background
PubMed Identifier
20587720
Citation
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.
Results Reference
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Omentectomy for Metabolic Syndrome in Gastric Cancer Patients

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