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Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

N

Nagasaki University

Status

Unknown

Conditions

Osteoporosis
Gastric Cancer
Sarcopenia

Study type

Observational

Funder types

Other

Identifiers

NCT03398226
17082126

Details and patient eligibility

About

Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The aim of the present study was to evaluate osteoporosis by using high-resolution peripheral quantitative computed tomography (HR-pQCT) in the long course after gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Full description

The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy, which is characterized by both the loss of bone mass and the deterioration of bone architecture, is a serious complication in the long course after gastrectomy. The primary tools for assessing volumetric density and bone structure are quantitative computed tomography (QCT) and more recently, high-resolution peripheral quantitative computed tomography (HR-pQCT). However the validation of osteoporosis with HR-pQCT before and after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

Enrollment

42 estimated patients

Sex

All

Ages

60 to 79 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Planning ESD, DG, or TG due to gastric cancer
  • Provide signed informed consent

Exclusion criteria

  • pregnancy
  • Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
  • Hyperthyroidism
  • Hyperparathyroidism
  • Present malignancy (except in situ carcinoma)
  • Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
  • Other diseases which affect bone metabolism
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
  • Received > 3 months (or equivalent) of osteoporosis treatment
  • Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).

Trial design

42 participants in 3 patient groups

Control group
Distal Gastrectomy (DG) group
Description:
38 patients planing distal gastrectomy due to gastric cancer
Total Gastrectomy (TG) group
Description:
38 patients planing total gastrectomy due to gastric cancer

Trial contacts and locations

1

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Central trial contact

Shinichiro Kobayashi, MD

Data sourced from clinicaltrials.gov

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