- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01132469
Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer (ESD)
Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Traditionally open-gastrectomy is the standard treatment for gastric cancer without distant metastasis, but high mortality and morbidity, the intense weight loss, food intake difficulties after surgery are fraught, including problems with the drawback of significantly degrading the quality of life. Therefore, a lot of effort to seek the more simple treatment than open gastrectomy has been made, recently the endoscopic treatment for early gastric cancer is the most widely used treatment.
This single-arm, multi-center study enroll early gastric cancer patients after ESD compared with the retrospective control(surgical treatment) group considering the unreality of the randomized clinical trials. In addition, the quality of life assessment by the EORTC C30/STO22 tools before and after ESD procedure in enrolled patients will be performed and the direct cost analysis also will be conducted.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Eunhee Shin, Ph.D.
- Telefonnummer: 82-2-2174-2740
- E-post: hshin@neca.re.kr
Studer Kontakt Backup
- Navn: Jonghee Kim, MS
- Telefonnummer: 82-2-2174-2742
- E-post: goldpaper2@neca.re.kr
Studiesteder
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-
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Busan, Korea, Republikken, 614-735
- Rekruttering
- Inje University Busan Baik Hospital and 10 other institutes
-
Ta kontakt med:
- Sang-Yong Seol, M.D.
- Telefonnummer: 82-51-890-6158
- E-post: seolsymd@hanmail.net
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Hovedetterforsker:
- Sang-Yong Seol, M.D.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
ESD GROUP
Inclusion Criteria:
- Korean people aged >=20 years
- Endoscopic Grossly the lesion diameter ≤ 3cm
- Endoscopic biopsy results: Well-differentiated and moderately differentiated adenocarcinoma
- No ulcers in lesions
- Endoscopic biopsy results: In case of gastric cancer, no metastasis in CT test performed before ESD procedure
Exclusion Criteria:
- Subject with history of malignant disease in other organs
- Subject with history of stomach surgery due to peptic ulceration etc.
- As the cases of an absolute contraindication of general anesthesia; Subject with chronic liver disease over Child score B, Subject with chronic Renal Disease requiring hemodialysis or peritoneal dialysis, Subject with heart failure more than Ⅲ score according to New York Heart Association Classification, Subject with severe systemic diseases such as respiratory disease
- Subject with Bleeding tendency
- Pregnant woman or woman with possibility of pregnancy
- Subject who cann't be obtained informed consent
- Subject who is unable to follow up for any other reason
- Surgery Group(Retrospective data collection)
Inclusion Criteria:
- Subject with gastric laparoscopy or open-surgery for treatment early gastric cancer during 2002.1.1 ~2004. 12. 31
- Korean people aged >=20 years
- Early gastric cancer confirmed by pathology during gastric surgery; Gastric cancer confirmed to the mucosal or submucosal regardless of lymph node metastasis
- No history of malignant disease in other organs
- No history of stomach surgery due to peptic ulceration etc.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Endoskopisk submukosal disseksjon
Enarm for ESD-prosedyre og retrospektiv kirurgisk prosedyre (Laparoskopi, Åpen kirurgi) datainnsamling
|
5-years follow-up after Endoscopic Submucosal Dissection
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
5-year disease(gastric cancer)-free survival rate after ESD procedure
Tidsramme: 5 years after ESD
|
5 years after ESD
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Short-term result(Histological complete resection,complication)
Tidsramme: within the first 7 days after ESD
|
within the first 7 days after ESD
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The incidence of reoccurrence and Ectopic foci
Tidsramme: within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
|
within the first 7 days and 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
|
The quality of life after ESD
Tidsramme: before and 7 days, 3months, 6months after ESD
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before and 7 days, 3months, 6months after ESD
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The costs of ESD
Tidsramme: From the admission to discharge
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From the admission to discharge
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The safety of ESD procedure
Tidsramme: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
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within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Sang-Yong Seol, M.D., Inje University College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NA09-003
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