Bone Microstructure by Using HR-pQCT After Esophagectomy

Not yet recruiting

• Conditions: Osteoporosis; Sarcopenia; Esophageal Cancer
• Interventions: Procedure: esophagectomy

• Registration Number: NCT05812235
• Lead Sponsor: Nagasaki University

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-02
• Study First Posted: 2023-04-13
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24
• Study Start: 2023-05-25
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 118

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Esophagectomy	esophagectomy	48 patients with esophagectomy due to esophageal cancer before no more than 3 years

Primary Outcome Measures

Name	Time	Method
Comparing bone microstructure in control and Esophagectomy groups	1day	volumetric bone mineral density

Secondary Outcome Measures

Name	Time	Method
Comparing bone microstructure with serum biomarkers of osteoporosis	1day	Correlation between bone mineral density in esophagectomy and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
Comparing bone microstructure with dual-energy X-ray absorptiometry	1day	Correlation of bone mineral density between esophagectomy and DXA