Bone Microstructure by Using HR-pQCT After Esophagectomy

April 21, 2023 updated by: Kobayashi Shinichiro, Nagasaki University

Bone Microstructure by Using High-resolution Peripheral Quantitative Computed Tomography 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Japanese

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Esophagectomy
48 patients with esophagectomy due to esophageal cancer before no more than 3 years
Procedure: esophagectomy
esophagectomy
Healthy Control
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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing bone microstructure with dual-energy X-ray absorptiometry
Time Frame: 1day
Correlation of bone mineral density between esophagectomy and DXA
1day
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)
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagasaki University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 25, 2023

Primary Completion (Anticipated)

March 1, 2026

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

April 2, 2023

First Submitted That Met QC Criteria

April 2, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NagasakiU3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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