Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer

30. desember 2008 oppdatert av: The Catholic University of Korea

Comparison of the Laparoscopy-Assisted Distal Gastrectomy(LADG) and Open Distal Gastrectomy (ODG) for Advanced Gastric Cancer (Stage Ib and II).

Among surgical methods for gastric cancer, incision about 15 ~20 cm length is prepared for open gastric cancer surgery while 0.5 ~ 1.2 cm is for laparoscopy gastric cancer surgery. Complications such as pain, abdominal adhesion, and problems associated with delayed recovery are common in open surgery because of large incision; however, those complications are less common in laparoscopy surgery because small sized incision is prepared. Range of surgery for curative dissection depends on the level of progress of a cancer, i.e., depends on whether gastric wall invasion, lymph node metastasis, or invasion to adjacent organs presented. Since recurrence in the lymph nodes after the operation is very common, the most important step in the gastric surgery is to dissect lymph node completely. According to the gastric cancer surgery manual published by Japan Gastric Cancer Association, more than D2 lymph node dissection is essential for improving survival rate in advanced gastric cancer. More than D2 lymph node dissection is relatively safely conducted by open surgery, whereas it is controversial in laparoscopy surgery because it is very hard to maintain surgical field under laparoscopic condition. Recently, widened rage of lymph node dissection by using laparoscopy is possible as laparoscopic surgical techniques are accumulated and new surgical devices are introduced. According to the case reports, D2 lymph node dissection by laparoscopy surgery shows similar results to the one by open surgery in aspects of recurrence rate and the number of dissected lymph node. Also, according to Hur and el., in case of upper gastric cancer, laparoscopy surgery is more useful to dissect #10 and #11 lymph node.In our prospective case study, the investigators would like to compare effectiveness, complications, patterns of recurrence, and survival rate between the two surgical approaches, laparoscopy distal gastrectomy and open distal gastrectomy. The investigators randomly operate the advanced gastric cancer patients, who need distal gastrectomy and D2 lymph node dissection. Surgical methods are selected randomly whether open surgery or laparoscopy surgery. Finally, the investigators wish our case report to contribute to the establishment of the safety and the effectiveness of laparoscopy surgery conducted for advanced gastric cancers. Consequently, our case report will contribute to establish the ideal surgical method for the advanced gastric cancer patients.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In both arms,subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery (4d, 4sb), hepatoduodenal ligament, superior mesenteric vein) wiil be performed basically. As a general rule, Billroth II method will be used for gastric reconstruction for all cases.Billroth II gastrectomy is to link the gastric pouch to the jejunum 10~15 cm distal to the ligament of Treitz. An antecolic or retrocolic gastrojejunostomy connects the jejunum to the stomach in one continuous segment. For anastomosis, absorbable suture is used. Anastomotic diameter is 5~6 cm length. Drainage tube is inserted through the right flank area and additional drainage tubes can be inserted as needed.

Studietype

Intervensjonell

Registrering (Forventet)

124

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Korea, Republikken
    • Gyunggi Do
      • Bucheon, Gyunggi Do, Korea, Republikken, 420-717
        • Rekruttering
        • Department of Surgery, Holy Family Hospital, The Catholic University of Korea
        • Hovedetterforsker:
          • Wook Kim, Professor
        • Underetterforsker:
          • Junhyun Lee, Instructor
        • Ta kontakt med:
        • Ta kontakt med:
    • Kyunggi-do
      • Pucheon, Kyunggi-do, Korea, Republikken, 420-717
        • Aktiv, ikke rekrutterende
        • Department of Surgery, Holy Family Hospital. College of Medicine. The Catholic University of Korea

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
  • Age: older than 20 year old, younger than 80 year old
  • Cancer core: located at the middle or lower part of stomach
  • Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
  • ASA score: ≤ 3
  • Informed consent patients (explanation about our clinical trials is provided to the patients or patrons, if patient is not available)

Exclusion Criteria:

  • Concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient
  • Patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy
  • Patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy)
  • Patient who was treated because of systemic inflammatory disease
  • Pregnant patient
  • Patient who suffer from bleeding tendency disease, such as hemophilia or patient taking anti-coagulant medication due to deep vein thrombosis

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Fremgangsmåte: laparoscopy-assisted distal gastrectomy
10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.Dissected stomach and lymph node are collected through additional 3~5 cm incision at the preexisting epigastric incision.Finally, Billroth II reconstruction is performed.
Andre navn:
  • LADG
Aktiv komparator: 2
Fremgangsmåte: open distal gastrectomy
Approximately 15~20 cm length incision is made from falciform process to periumbilical area. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. As a general rule, Billroth II method was used for gastric reconstruction for all cases.
Andre navn:
  • ODG

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
2 year survival
Tidsramme: two year
two year

Sekundære resultatmål

Resultatmål
Tidsramme
efficacy and clinical out come
Tidsramme: two year
two year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Catholic University of Korea

Etterforskere

  • Studiestol: Wook Kim, Professor, Department of Surgery, Holy Family Hospital. The Catholic University of Korea

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2008

Primær fullføring (Forventet)

1. juli 2013

Studiet fullført (Forventet)

1. juli 2013

Datoer for studieregistrering

Først innsendt

25. august 2008

Først innsendt som oppfylte QC-kriteriene

25. august 2008

Først lagt ut (Anslag)

26. august 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. desember 2008

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. desember 2008

Sist bekreftet

1. august 2008

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HFHGS01

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Neoplasma i magen

Kliniske studier på open distal gastrectomy

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Venezuela

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere