Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT
2018年1月12日 更新者：Kobayashi Shinichiro、Nagasaki University
Chronological Change of Bone Microstructure After Gastrectomy
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
42
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Shinichiro Kobayashi, MD
- 电话号码：958197316
- 邮箱：shinichirokobayashi@nagasaki-u.ac.jp
学习地点
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Nagasaki、日本、852-8501
- 招聘中
- Nagasaki University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
60年 至 79年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Japanese
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
|---|
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控制组
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Distal Gastrectomy (DG) group
38 patients planing distal gastrectomy due to gastric cancer
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Total Gastrectomy (TG) group
38 patients planing total gastrectomy due to gastric cancer
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparing bone microstructure in control, DG, and TG groups
大体时间：2 years after the treatments
|
volumetric bone mineral density loss comparing with before the treatments
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2 years after the treatments
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comparing bone microstructure with sarcopenia
大体时间：Before the treatments and 1 and 2 years after the treatments
|
Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
|
Before the treatments and 1 and 2 years after the treatments
|
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Comparing bone microstructure with serum biomarkers of osteoporosis
大体时间：Before the treatments and 1 and 2 years after the treatments
|
Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
|
Before the treatments and 1 and 2 years after the treatments
|
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Comparing bone microstructure with dual-energy X-ray absorptiometry
大体时间：Before the treatments and 1 and 2 years after the treatments
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Correlation of bone mineral density between HR-pQCT and DXA
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Before the treatments and 1 and 2 years after the treatments
|
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Comparing bone microstructure with quality of life (QOL-C30)
大体时间：Before the treatments and 1 and 2 years after the treatments
|
Patients will be asked to complete a short debriefing questionnaire covering questions.(QOL-C30).
We compared the average sore about Valid and reliable 30-item questionnaire assessing health related quality of life (6 functional, 9 symptom) before and after treatments.
The score about QOL-C30 is evaluated on a four level scale without Global quality of life.
Global quality of life is evaluated on a seven level scale.
|
Before the treatments and 1 and 2 years after the treatments
|
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Comparing bone microstructure with quality of life (BDHQ)
大体时间：Before the treatments and 1 and 2 years after the treatments
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Patients will be asked to complete a short debriefing questionnaire covering questions (BDHQ) B-DHQ is 58-item fixed-portion-type questionnaire The score about BDHQ is evaluated on a seven level scale.
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (FRAX)
大体时间：Before the treatments and 1 and 2 years after the treatments
|
Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX).
FRAX score is 12. FRAX is 12-item fixed-portion-type questionnaire.
The score about FRAX is evaluated on a two level scale.
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Before the treatments and 1 and 2 years after the treatments
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月18日
初级完成 (预期的)
2020年3月31日
研究完成 (预期的)
2023年3月31日
研究注册日期
首次提交
2017年9月17日
首先提交符合 QC 标准的
2018年1月7日
首次发布 (实际的)
2018年1月12日
研究记录更新
最后更新发布 (实际的)
2018年1月17日
上次提交的符合 QC 标准的更新
2018年1月12日
最后验证
2018年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.