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Efficacy and Safety Study of Endoscopic Submucosal Dissection for Early Gastric Cancer (ESD)

26. maj 2010 opdateret af: National Evidence-Based Healthcare Collaborating Agency

Long-term Follow-up After Endoscopic Submucosal Dissection for Early Gastric Cancer

The purpose of this study is to evaluate the safety and clinical effectiveness of ESD(Endoscopic Submucosal Dissection) for early gastric cancer analyzing short-term and long-term results of endoscopic treatment.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

1158

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
      • Busan, Korea, Republikken, 614-735
        • Rekruttering
        • Inje University Busan Baik Hospital and 10 other institutes
        • Kontakt:
        • Ledende efterforsker:
          • Sang-Yong Seol, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

  1. 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
  2. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Endoskopisk submukosal dissektion
Enkeltarm til ESD-procedure og retrospektiv kirurgisk procedure (Laparoskopi, Åben kirurgi) dataindsamling
Procedure: Endoscopic Submucosal Dissection
5-years follow-up after Endoscopic Submucosal Dissection

Hvad måler undersøgelsen?

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
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
before and 7 days, 3months, 6months after ESD
The costs of ESD
Tidsramme: From the admission to discharge
From the admission to discharge
The safety of ESD procedure
Tidsramme: within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD
within the 7 days, 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Evidence-Based Healthcare Collaborating Agency

Efterforskere

  • Ledende efterforsker: Sang-Yong Seol, M.D., Inje University College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2010

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. juni 2017

Datoer for studieregistrering

Først indsendt

24. maj 2010

Først indsendt, der opfyldte QC-kriterier

26. maj 2010

Først opslået (Skøn)

28. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. maj 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2010

Sidst verificeret

1. maj 2010

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NA09-003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Tidlig mavekræft

Kliniske forsøg med Endoscopic Submucosal Dissection

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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