NCT02541461

Brief Summary

Nutritional status including changes of body composition is one of the most important clinical determinants of outcome after gastrectomy for gastric cancer. Various type of gastric operations are widely used with favorable outcome in South Korea. It was reported that several advantages of laparoscopic gastrectomy are the prevention of overt weight loss and enhanced recovery of muscle mass at 6 months after surgery. But there have been no longitudinal studies evaluating changes in the body composition according to the different type of anastomosis of laparoscopic gastrectomy. The purpose of this prospective study was to investigate changes in lipid indices associated with whole body composition during 1 year of follow-up after laparoscopic gastrectomy. Gastrectomy resulted in improved lipid indices and a reduction in body weight, fat and LBM. The HDL-Csignificantly increased in the non-obese group for 1 year after gastrectomy and the reduction of TG level was positively correlated with fat, especially with trunk fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

September 1, 2015

Last Update Submit

August 10, 2018

Conditions

Gastric CancerBenign Gastric Tumor

Keywords

Body composition measurementLipid profileWeight lossGastrectomy

Outcome Measures

Primary Outcomes (1)

  • Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)

    Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed

    pre-surgery, 6 and 12 months post-surgery

Secondary Outcomes (1)

  • Changes in lipid profile

    pre-surgery, 6 and 12 months post-surgery

Study Arms (2)

Non-Obese

OTHER

Patients who underwent laparoscopic gastrectomy and with BMI \< 25 kg/m2

Procedure: Laparoscopic gastrectomy

Obese

OTHER

Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2

Procedure: Laparoscopic gastrectomy

Interventions

Laparoscopic gastrectomyPROCEDURE

(1) Wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) Laparoscopic gastrectomy; (4) Gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy

Non-ObeseObese

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with gastric cancer or benign gastric neoplasm planning gastric operation
  • Stage I and II patients by preoperative screening

You may not qualify if:

  • Distant metastasis
  • Severe comorbidity
  • Malnourished state
  • Inability of access to enteral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University Seoul Hospital

Seoul, South Korea

Location

Related Publications (11)

  • Song J, Lee HJ, Cho GS, Han SU, Kim MC, Ryu SW, Kim W, Song KY, Kim HH, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Recurrence following laparoscopy-assisted gastrectomy for gastric cancer: a multicenter retrospective analysis of 1,417 patients. Ann Surg Oncol. 2010 Jul;17(7):1777-86. doi: 10.1245/s10434-010-0932-4. Epub 2010 Feb 12.

    PMID: 20151217BACKGROUND

  • Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.

    PMID: 8180768BACKGROUND

  • Lee HJ, Kim HH, Kim MC, Ryu SY, Kim W, Song KY, Cho GS, Han SU, Hyung WJ, Ryu SW; Korean Laparoscopic Gastrointestinal Surgery Study Group. The impact of a high body mass index on laparoscopy assisted gastrectomy for gastric cancer. Surg Endosc. 2009 Nov;23(11):2473-9. doi: 10.1007/s00464-009-0419-1. Epub 2009 Apr 3.

    PMID: 19343439BACKGROUND

  • Kim MC, Kim W, Kim HH, Ryu SW, Ryu SY, Song KY, Lee HJ, Cho GS, Han SU, Hyung WJ; Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) Group. Risk factors associated with complication following laparoscopy-assisted gastrectomy for gastric cancer: a large-scale korean multicenter study. Ann Surg Oncol. 2008 Oct;15(10):2692-700. doi: 10.1245/s10434-008-0075-z. Epub 2008 Jul 29.

    PMID: 18663532BACKGROUND

  • Kim HH, Hyung WJ, Cho GS, Kim MC, Han SU, Kim W, Ryu SW, Lee HJ, Song KY. Morbidity and mortality of laparoscopic gastrectomy versus open gastrectomy for gastric cancer: an interim report--a phase III multicenter, prospective, randomized Trial (KLASS Trial). Ann Surg. 2010 Mar;251(3):417-20. doi: 10.1097/SLA.0b013e3181cc8f6b.

    PMID: 20160637BACKGROUND

  • Liedman B, Svedlund J, Sullivan M, Larsson L, Lundell L. Symptom control may improve food intake, body composition, and aspects of quality of life after gastrectomy in cancer patients. Dig Dis Sci. 2001 Dec;46(12):2673-80. doi: 10.1023/a:1012719211349.

    PMID: 11768259BACKGROUND

  • Kiyama T, Mizutani T, Okuda T, Fujita I, Tokunaga A, Tajiri T, Barbul A. Postoperative changes in body composition after gastrectomy. J Gastrointest Surg. 2005 Mar;9(3):313-9. doi: 10.1016/j.gassur.2004.11.008.

    PMID: 15749590BACKGROUND

  • Abdiev S, Kodera Y, Fujiwara M, Koike M, Nakayama G, Ohashi N, Tanaka C, Sakamoto J, Nakao A. Nutritional recovery after open and laparoscopic gastrectomies. Gastric Cancer. 2011 Jun;14(2):144-9. doi: 10.1007/s10120-011-0021-9. Epub 2011 Feb 16.

    PMID: 21327442BACKGROUND

  • Aoyama T, Yoshikawa T, Hayashi T, Hasegawa S, Tsuchida K, Yamada T, Cho H, Ogata T, Fujikawa H, Yukawa N, Oshima T, Rino Y, Masuda M. Randomized comparison of surgical stress and the nutritional status between laparoscopy-assisted and open distal gastrectomy for gastric cancer. Ann Surg Oncol. 2014 Jun;21(6):1983-90. doi: 10.1245/s10434-014-3509-9. Epub 2014 Feb 6.

    PMID: 24499830BACKGROUND

  • Jeon TY, Lee S, Kim HH, Kim YJ, Lee JG, Jeong DW, Kim YJ. Long-term changes in gut hormones, appetite and food intake 1 year after subtotal gastrectomy with normal body weight. Eur J Clin Nutr. 2010 Aug;64(8):826-31. doi: 10.1038/ejcn.2010.83. Epub 2010 May 19.

    PMID: 20485300BACKGROUND

  • Liedman B, Henningsson A, Mellstrom D, Lundell L. Changes in bone metabolism and body composition after total gastrectomy: results of a longitudinal study. Dig Dis Sci. 2000 Apr;45(4):819-24. doi: 10.1023/a:1005420416192.

    PMID: 10759255BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsWeight Loss

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yun Young Choi, MD, PhD

    Hanyang University Seoul Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 4, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

KR(1)