Bone Microstructure by Using HR-pQCT After Esophagectomy

NCT ID: NCT05812235

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2027-03-31

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.

Conditions

Osteoporosis; Sarcopenia; Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Esophagectomy

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

esophagectomy

Intervention Type: PROCEDURE

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)

No interventions assigned to this group

Interventions

esophagectomy

esophagectomy

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nagasaki University

OTHER

Sponsor Role: lead

Responsible Party

Kobayashi Shinichiro

Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shinichiro Kobayashi

Role: CONTACT

shinichirokobayashi@nagasaki-u.ac.jp

0958197316

Other Identifiers

NagasakiU3

Identifier Type: -

Identifier Source: org_study_id