Bone Microstructure by Using HR-pQCT After Esophagectomy

Study Overview
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Brief Summary
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Esophagectomy is most curative treatment to esophageal cancer. However, osteoporosis , 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 surgery. 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 esophagectomy. At least 3 years should have elapsed since operation without recurrence of esophageal cancer.

Detailed Description
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The patients after esophagectomy loss appetite and decrease the weight. Esophagectomy especially cause severe sarcopenia and metabolic change. Osteoporosis, 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 esophagectomy. 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 in the long course after esophagectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT in the long course after esophagectomy. At least 3 years should have elapsed since esophagectomy without any recurrence.

Official Title
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Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography After Esophagectomy

Conditions
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Osteoporosis, Sarcopenia, Esophageal Cancer

Intervention / Treatment
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* Procedure: esophagectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 3 years have elapsed since esophagectomy due to esophageal cancer Provide signed informed consent Exclusion Criteria: Current use of the following osteoporosis agents; Teriparatide, Denosumab, and - - bisphosphonate Present malignancy (except in situ carcinoma) Radiotherapy 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).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Esophagectomy<br>48 patients with esophagectomy due to esophageal cancer before no more than 3 years | Procedure: esophagectomy<br>* esophagectomy<br>|
| Healthy Control<br>70 patients without gastrectomy , who are similar background in other group, are collected from date Pathologic analysis of primary osteoporosis: investigating age and osteoporosis related changes of bone microstructure by using HR-pQCT (UMIN000023535) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing bone microstructure in control and Esophagectomy groups | volumetric bone mineral density | 1day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing bone microstructure with serum biomarkers of osteoporosis | Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b) | 1day | 
| Comparing bone microstructure with dual-energy X-ray absorptiometry | Correlation of bone mineral density between esophagectomy and DXA | 1day |