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Bone Microstructure by Using HR-pQCT After Esophagectomy

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05812235
Enrollment
118
Registered
2023-04-13
Start date
2023-05-25
Completion date
2027-03-31
Last updated
2023-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer, Osteoporosis, Sarcopenia

Brief summary

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

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.

Interventions

PROCEDUREesophagectomy

esophagectomy

Sponsors

Nagasaki University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Comparing bone microstructure in control and Esophagectomy groups1dayvolumetric bone mineral density

Secondary

MeasureTime frameDescription
Comparing bone microstructure with serum biomarkers of osteoporosis1dayCorrelation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Comparing bone microstructure with dual-energy X-ray absorptiometry1dayCorrelation of bone mineral density between esophagectomy and DXA

Contacts

Primary ContactShinichiro Kobayashi
shinichirokobayashi@nagasaki-u.ac.jp0958197316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026