Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541461
• Other study ID #: 2015-04-026-002
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2018
• Source: Hanyang University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• All patients will undergo a laparoscopic gastrectomy for their gastric cancer (proved to be stage I or II) or benign gastric neoplasm by preoperative screening diagnostic procedure. They will receive laparoscopic gastrectomy as follows: (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.

• Pre-operative, 6 and 12 months post-operative body composition measurement will be performed on each patient. The whole body composition measurement will be assessed by Hologic 4500/A dual energy X-ray absorptiometry system. The software performs calculations of the differential attenuations of the two photon energies and present data of percentage of fat, fat mass (g), lean mass (g), bone mineral content (g), bone mineral density (g/cm2), and total mass (g).

• Laboratory analysis - There is a battery of labs that are ordered in both the pre-operative, 6 and 12 months post-operative time frame. These labs are ordered independent of the patient's participation in the study. These labs are ordered to evaluate and to assist management of the patient's medical comorbidities as well as to assess for adequate nutritional intake and balance.

• Queries on nutritional intake and exercise will be made at each post-operative appointment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient with gastric cancer or benign gastric neoplasm planning gastric operation

• Stage I and II patients by preoperative screening

Exclusion Criteria:

• Distant metastasis

• Severe comorbidity

• Malnourished state

• Inability of access to enteral feeding

Related Conditions & MeSH terms

• Benign Gastric Tumor
• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Laparoscopic gastrectomy
(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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8. Erratum in: Surg Laparosc Endosc. 2013 Oct;23(5):480. — View Citation

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. — View Citation

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. — View Citation

Liedman B, Henningsson A, Mellström 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in lipid profile	Using laboratory analysis, changes in the lipid profiles (total cholesterol (TC), triglyceride (TG), LDL-C and HDL-C) following gastric operation assessed	pre-surgery, 6 and 12 months post-surgery