Bone Microstructure by Using HR-pQCT After Esophagectomy

Sponsor

Nagasaki University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05812235

Collaborator

(none)

128

Enrollment

46.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Sarcopenia Esophageal Cancer	Procedure: esophagectomy

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

128 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Esophagectomy 51 patients with esophagectomy due to esophageal cancer before no more than 3 years	Procedure: esophagectomy esophagectomy
Healthy Control 77 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)

Arm

Intervention/Treatment

Esophagectomy

51 patients with esophagectomy due to esophageal cancer before no more than 3 years

Procedure: esophagectomy

esophagectomy

Healthy Control

77 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)

Outcome Measures

Primary Outcome Measures

Comparing bone microstructure in control and Esophagectomy groups [1day]
volumetric bone mineral density

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nagasaki University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kobayashi Shinichiro, Surgery, Nagasaki University

ClinicalTrials.gov Identifier:

NCT05812235

Other Study ID Numbers:

NagasakiU3

First Posted:

Apr 13, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoporosis

Sarcopenia

Study Results

No Results Posted as of Apr 18, 2023