Bone Microstructure After Gastrectomy Evaluating by Using HR-pQCT
12 januari 2018 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
42
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Shinichiro Kobayashi, MD
- Telefonnummer: 958197316
- E-post: shinichirokobayashi@nagasaki-u.ac.jp
Studieorter
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Nagasaki, Japan, 852-8501
- Rekrytering
- Nagasaki University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
60 år till 79 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Sannolikhetsprov
Studera befolkning
Japanese
Beskrivning
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).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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Kontrollgrupp
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Distal Gastrectomy (DG) group
38 patients planing distal gastrectomy due to gastric cancer
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Total Gastrectomy (TG) group
38 patients planing total gastrectomy due to gastric cancer
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparing bone microstructure in control, DG, and TG groups
Tidsram: 2 years after the treatments
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volumetric bone mineral density loss comparing with before the treatments
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2 years after the treatments
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Comparing bone microstructure with sarcopenia
Tidsram: Before the treatments and 1 and 2 years after the treatments
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Correlation between bone mineral density in HR-pQCT and cross-sectional area of the abdominal psoas major muscle
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with serum biomarkers of osteoporosis
Tidsram: Before the treatments and 1 and 2 years after the treatments
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Correlation between bone mineral density in HR-pQCT and biomarkers (25-hydroxyvitaminD, calcium, iPTH, P1NP, ICTP, TRACP5b)
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with dual-energy X-ray absorptiometry
Tidsram: Before the treatments and 1 and 2 years after the treatments
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Correlation of bone mineral density between HR-pQCT and DXA
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (QOL-C30)
Tidsram: Before the treatments and 1 and 2 years after the treatments
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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.
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (BDHQ)
Tidsram: Before the treatments and 1 and 2 years after the treatments
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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.
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Before the treatments and 1 and 2 years after the treatments
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Comparing bone microstructure with quality of life (FRAX)
Tidsram: Before the treatments and 1 and 2 years after the treatments
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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.
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Before the treatments and 1 and 2 years after the treatments
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 september 2017
Primärt slutförande (Förväntat)
31 mars 2020
Avslutad studie (Förväntat)
31 mars 2023
Studieregistreringsdatum
Först inskickad
17 september 2017
Först inskickad som uppfyllde QC-kriterierna
7 januari 2018
Första postat (Faktisk)
12 januari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2018
Senast verifierad
1 januari 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 17082126
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