Menu
Not yet recruiting NCT05812235

Bone Microstructure by Using HR-pQCT After Esophagectomy

Observational Osteoporosis Sarcopenia Esophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: esophagectomy.
Who it may be relevant to
Registry conditions: Osteoporosis, Sarcopenia, Esophageal Cancer. Basic parameters: 50 years — 90 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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

  • Procedure esophagectomy
    esophagectomy

Primary outcome measures

  • Comparing bone microstructure in control and Esophagectomy groups [Time frame: 1day]
Secondary outcome measures (2)
  • Comparing bone microstructure with serum biomarkers of osteoporosis [Time frame: 1day]
  • Comparing bone microstructure with dual-energy X-ray absorptiometry [Time frame: 1day]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05812235 · NagasakiU3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗