Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

NCT ID: NCT03398226

Last Updated: 2018-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-18

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis Sarcopenia Gastric Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group

No interventions assigned to this group

Distal Gastrectomy (DG) group

38 patients planing distal gastrectomy due to gastric cancer

No interventions assigned to this group

Total Gastrectomy (TG) group

38 patients planing total gastrectomy due to gastric cancer

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nagasaki University

OTHER

Sponsor Role lead

Responsible Party

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Kobayashi Shinichiro

Principal Investigator in department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nagasaki University Hospital

Nagasaki, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Shinichiro Kobayashi, MD

Role: CONTACT

958197316

Facility Contacts

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Kobayashi Shinichiro, M.D.

Role: primary

+81958197316

Other Identifiers

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17082126

Identifier Type: -

Identifier Source: org_study_id

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