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Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT

12 januari 2018 bijgewerkt door: Kobayashi Shinichiro, Nagasaki University

Chronological Change of Bone Microstructure After Gastrectomy

Osteoporosis after gastrectomy, 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 gastrectomy. 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 gastrectomy. In total gastrectomy and distal gastrectomy groups, at least 5 years should have elapsed since gastrectomy.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

The patients after gastrectomy loss appetite and decrease the weight. Total gastrectomy especially cause severe sarcopenia and metabolic change. Osteoporosis after gastrectomy, 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 gastrectomy. 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 before and after gastrectomy remain elusive. The aim of the present study was to evaluate osteoporosis by using HR-pQCT before and after after endoscopic resection, distal gastrectomy, and total gastrectomy in the patients with gastric cancer.

Studietype

Observationeel

Inschrijving (Verwacht)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Shinichiro Kobayashi, MD
Telefoonnummer: 958197316
E-mail: shinichirokobayashi@nagasaki-u.ac.jp

Studie Locaties

Japan
- - Nagasaki, Japan, 852-8501
    - Werving
    - Nagasaki University Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

60 jaar tot 79 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Japanese

Beschrijving

Inclusion Criteria:

Planning ESD, DG, or TG due to gastric cancer
Provide signed informed consent

Exclusion Criteria:

pregnancy
Current use of the following osteoporosis agents; Teriparatide, Denosumab, and bisphosphonate
Hyperthyroidism
Hyperparathyroidism
Present malignancy (except in situ carcinoma)
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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Prospectief

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Controlegroep
Distal Gastrectomy (DG) group 38 patients planing distal gastrectomy due to gastric cancer
Total Gastrectomy (TG) group 38 patients planing total gastrectomy due to gastric cancer

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Comparing bone microstructure in control, DG, and TG groups Tijdsspanne: 2 years after the treatments	volumetric bone mineral density loss comparing with before the treatments	2 years after the treatments

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Comparing bone microstructure with sarcopenia Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with serum biomarkers of osteoporosis Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with dual-energy X-ray absorptiometry Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Correlation of bone mineral density between HR-pQCT and DXA	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (QOL-C30) Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Patients will be asked to complete a short debriefing questionnaire covering questions.(QOL-C30). We compared the average sore about Valid and reliable 30-item questionnaire assessing health related quality of life (6 functional, 9 symptom) before and after treatments. The score about QOL-C30 is evaluated on a four level scale without Global quality of life. Global quality of life is evaluated on a seven level scale.	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (BDHQ) Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Patients will be asked to complete a short debriefing questionnaire covering questions (BDHQ) B-DHQ is 58-item fixed-portion-type questionnaire The score about BDHQ is evaluated on a seven level scale.	Before the treatments and 1 and 2 years after the treatments
Comparing bone microstructure with quality of life (FRAX) Tijdsspanne: Before the treatments and 1 and 2 years after the treatments	Patients will be asked to complete a short debriefing questionnaire covering questions (FRAX). FRAX score is 12. FRAX is 12-item fixed-portion-type questionnaire. The score about FRAX is evaluated on a two level scale.	Before the treatments and 1 and 2 years after the treatments

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nagasaki University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 september 2017

Primaire voltooiing (Verwacht)

31 maart 2020

Studie voltooiing (Verwacht)

31 maart 2023

Studieregistratiedata

Eerst ingediend

17 september 2017

Eerst ingediend dat voldeed aan de QC-criteria

7 januari 2018

Eerst geplaatst (Werkelijk)

12 januari 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 januari 2018

Laatste update ingediend die voldeed aan QC-criteria