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NCT Number: NCT05812235

Bone Microstructure by Using HR-pQCT After Esophagectomy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Esophagectomy

Procedure

esophagectomy

Primary outcomes

  1. Comparing bone microstructure in control and Esophagectomy groups

    Time frame: 1day

    volumetric bone mineral density

Secondary outcomes

  1. Comparing bone microstructure with serum biomarkers of osteoporosis

    Time frame: 1day

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

  2. Comparing bone microstructure with dual-energy X-ray absorptiometry

    Time frame: 1day

    Correlation of bone mineral density between esophagectomy and DXA

Study contacts

Contact information is provided by the study sponsor or research team.

Shinichiro Kobayashi

CONTACT

[email protected]

0958197316

Sponsors and collaborators

Lead sponsor

Nagasaki University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 13, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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