Bone Microstructure by Using HR-pQCT After Esophagectomy

N/ANot Yet RecruitingNCT05812235

Nagasaki University118 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

118

Conditions

Osteoporosis Sarcopenia Esophageal Cancer

Interventions

esophagectomyPROCEDURE

esophagectomy

Eligibility

Sex: MALEMin age: 50 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Comparing bone microstructure in control and Esophagectomy groups

volumetric bone mineral density

Time frame: 1day

Secondary Outcomes

Comparing bone microstructure with serum biomarkers of osteoporosis

Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)

Time frame: 1day

Comparing bone microstructure with dual-energy X-ray absorptiometry

Correlation of bone mineral density between esophagectomy and DXA

Time frame: 1day

Central Contacts

Shinichiro Kobayashi

CONTACT

0958197316 shinichirokobayashi@nagasaki-u.ac.jp

Data from ClinicalTrials.gov

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