Gastric CancerNCT02541461

Body Composition After Laparoscopic Gastrectomy for Gastric Cancer

A study testing Laparoscopic gastrectomy in people with Gastric Cancer and Benign Gastric Tumor, run by Hanyang University Seoul Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Gastric Cancer, Benign Gastric Tumor
What is being tested?: Laparoscopic gastrectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteSouth Korea
Study dates: May 2015to Jan 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Hanyang University Seoul Hospital
Seoul

Other trials in South Korea

About this study

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

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.

Read the detailed 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.

Conditions: Gastric Cancer, Benign Gastric Tumor
Being tested: Laparoscopic gastrectomy
Keywords: Body composition measurement, Lipid profile, Weight loss, Gastrectomy
Medical subject headings: Stomach Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic gastrectomyProcedure or surgery
(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

Study groups in NCT02541461
Study group	Role	What they receive
Non-Obese	Other	Patients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2 Receives: Procedure: Laparoscopic gastrectomy
Obese	Other	Patients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2 Receives: Procedure: Laparoscopic gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: pre-surgery, 6 and 12 months post-surgery

Secondary outcomes (1)

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
Measured: pre-surgery, 6 and 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Jan 2017

First posted4 Sep 2015 (estimated)
Study startMay 2015
Primary completionDec 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02541461
Sponsor's protocol ID: 2015-04-026-002
Status last verified: Aug 2018
First submitted: 1 Sep 2015
Last updated: 13 Aug 2018
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 20151217
Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
PubMed 8180768
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.
PubMed 19343439
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.
PubMed 18663532
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.
PubMed 20160637
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.
PubMed 11768259
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.
PubMed 15749590
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.
PubMed 21327442
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.
PubMed 24499830
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.
PubMed 20485300
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.
PubMed 10759255

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastric Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes in Lipid Indices and Body Composition One Year After Laparoscopic Gastrectomy: a Prospective Study
ClinicalTrials.gov ID: NCT02541461
Acronym / sponsor ID: 2015-04-026-002
Conditions: Gastric Cancer, Benign Gastric Tumor
Keywords: Body composition measurement, Lipid profile, Weight loss, Gastrectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Hanyang University Seoul HospitalUniversity, hospital or other
Study start: May 2015 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 4 Sep 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Non-Obese	Other	Procedure: Laparoscopic gastrectomyPatients who underwent laparoscopic gastrectomy and with BMI < 25 kg/m2
Obese	Other	Procedure: Laparoscopic gastrectomyPatients who underwent laparoscopic gastrectomy and with BMI ≥ 25 kg/m2

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Procedure or surgery	Non-Obese, Obese

Primary outcome

Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic)
Time frame: pre-surgery, 6 and 12 months post-surgery
Using DEXA machine produced by Hologic (QDR 4500), changes in lean tissue mass and fatty tissue mass following gastric operation assessed

1 secondary outcome

Changes in lipid profile
Time frame: pre-surgery, 6 and 12 months post-surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Background: PubMed 20151217Song 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.
Background: PubMed 8180768Kitano S, Iso Y, Moriyama M, Sugimachi K. Laparoscopy-assisted Billroth I gastrectomy. Surg Laparosc Endosc. 1994 Apr;4(2):146-8.
Background: PubMed 19343439Lee 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.
Background: PubMed 18663532Kim 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.
Background: PubMed 20160637Kim 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.
Background: PubMed 11768259Liedman 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.
Background: PubMed 15749590Kiyama 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.
Background: PubMed 21327442Abdiev 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.
Background: PubMed 24499830Aoyama 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.
Background: PubMed 20485300Jeon 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.
Background: PubMed 10759255Liedman 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.

Related trials for Gastric Cancer

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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yun Young Choi, MD, PhD principal investigator

Hanyang University Seoul Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic gastrectomy in people with Gastric Cancer and Benign Gastric Tumor, run by Hanyang University Seoul Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body composition (changes in lean tissue mass and fatty tissue mass Using DEXA machine produced by Hologic) (time frame: pre-surgery, 6 and 12 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02541461, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.