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Clinical Study on Laparoscopic Gastrectomy for Early Gastric Cancer (COACT_0301) (NCC052)

22. Mai 2012 aktualisiert von: Young-Woo Kim, National Cancer Center, Korea

Prospective Randomized Trial of Laparoscopy-assisted Distal Gastrectomy (LADG) Versus Open Distal Gastrectomy (ODG) in Patients With Early Gastric Cancer (EGC)

Rationale: For the treatment of early gastric cancer (EGC) in the distal portion of the stomach, subtotal gastrectomy and lymph node dissection has been a standard operation. With the increasing tendency toward minimally invasive surgery, there has been an effort to apply minimally invasive techniques to the treatment of EGC. Laparoendoluminal mucosectomy and lesion-lifting gastric wedge resection have been developed for this purpose. However, these methods have the disadvantage of limited indications according to the size, shape and depth of invasion. Kitano et al. performed the first laparoscopy-assisted subtotal gastrectomy with lymph node dissection and manual anastomosis with anterior wall lifting method for a patient with EGC. In 1995, Uyama et al. and Nagai et al. performed laparoscopy-assisted subtotal gastrectomy with lymph node dissections using an automatic stapler instead of manual anastomosis for the gastroduodenal anastomosis. It has been possible to maintain an adequate distance from the lesion to the proximal and distal margins of resection, to perform radical lymph node dissection, and to achieve excellent postoperative recovery. However, there is a very limited evidence of superiority of laparoscopic gastrectomy over open surgery. There is only one interim report of randomized clinical trial of comparing laparoscopic gastrectomy and open gastrectomy. A well-designed clinical study to prove the benefit and safety is definitely needed Objective: to compare Laparoscopy - assisted Distal Gastrectomy (LADG) with Open Distal Gastrectomy (ODG) in terms of survival, recovery, pain, complications, and quality of life (QOL) Hypothesis: LADG is beneficial in QOL, pain, recovery, complications while maintaining equivalent survival with ODG

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  1. Randomization

    Randomization is done by person who is not involved in study. So it is done by the person in Center for Clinical Trial in National Cancer Center. The patient is enrolled in the out-patient clinic after getting informed consent of the clinical study from the patient. Surgeon factor is not considered as a randomization factor because this clinical study will be performed intramurally. In Center for Gastric Cancer, National Cancer Center, Surgical techniques and extent of resections are generally standardized and surgical outcomes are same in terms of complication and recovery.

  2. Follow-up schedule

    Patients are followed up in the outpatient department at four weeks, three months, six months, and twelve months after the operation, and every six months thereafter. On each visit, history was reviewed and physical examination was done. A complete blood count (CBC) and serum chemistry were evaluated also. An esophago-gastro-duodenoscopy (EGD) was performed at three months after the operation and yearly thereafter. Abdominal computed tomography (ACT) was evaluated annually.

  3. Assessment of QOL The European EORTC QLQ-C30 (version 3.0) questionnaire is a 30-item cancer-specific integrated system for assessing the health-related QOL of cancer patients. The questionnaire incorporates five scales of function (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation and diarrhea), as well as the perceived financial impact of the disease and treatment. All items were scored on four-point Likert scales, with the exception of two items in the global health QOL scale, which used modified seven-point linear analog scales. The EORTC QLQ-STO22 with a 22-item stomach cancer-specific questionnaire was also used. It incorporates five hypothesized scales-(dysphasia, eating restrictions, pain, reflux and anxiety) and four single items (having a dry mouth, body image, taste, and hair loss) covering disease and treatment-related symptoms and specific emotional consequences of gastric cancer.12 All instruments of the questionnaire were administered preoperatively and postoperatively at seven days, 30 days, 90 days and yearly. Those time points were chosen at usual follow-up schedule for every gastrectomized patients in our institute, to maximize compliance for the questionnaire, and to compare other parameters at the same time.
  4. Statistical analyses The EORTC QLQ-C30 symptom subscale and the EORTC QLQ-STO22 subscale scores are reported using a scale from 0 to 100. Statistical analyses of the QOL outcomes evaluated the differences between the LADG and the ODG groups with respect to the overall changes from the preoperative scores (baseline) to those obtained at follow-up. To adjust for possible baseline differences, we included the baseline values in the model. All comparisons between groups were based on 'intent-to-treat' analyses in which patients were analyzed according to their assigned treatment group. Categorical variables were compared using the χ2 test, and continuous variables were analyzed using the Student's t-test. Analysis of Covariance (ANCOVA) with repeated measures was used to compare the two groups of patients with respect to overall changes in their short term quality of life after the surgery. The SAS (SAS Institute Inc., Cary, NC, USA) program called 'PROC GLM' was used.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

164

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Korea, Republik von
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republik von, 410-769
        • National Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of stomach
  • Age: 18-80 years
  • Performance status: ECOG 0-1
  • Informed consent should be signed
  • EGD finding of early gastric cancer
  • EUS finding of mucosa and submucosa cancer
  • The location of the tumor should be antrum, angle, lower body in greater curvature in UGIS
  • No evidence of distant metastasis in abdomen CT, and chest PA
  • Regional lymph node metastasis confined to perigastric node (N1) in CT and EUS

Exclusion Criteria:

  • Any comorbidity obviating major surgery
  • Contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy
  • Previous upper abdominal operation
  • Indication of EMR: well or moderately differentiated adenocarcinoma, less than 2 cm in EGC type I and IIa, less than 1cm in EGC type IIb and IIc, no ulceration
  • Complicated case needed to get emergency operation
  • Any accompanying surgical condition needed to be performed in same time

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Laparoscopy assisted distal gastrectomy
Laparoscopy assisted distal gastrectomy with D2 lymph node dissection.Surgery will be done in similar operative extent with control open distal gastrectomy. Omentectomy will be omitted.
Verfahren: laparoscopy assisted distal gastrectomy
under general endotracheal anesthesia, Five laparoscopic ports are made. Lymph node dissection and ligations of vessels are done in laparoscopic field. A 5-6cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, stomach is taken out and resected. A Billroth I gastroduodenostomy using EEA stapler and GIA is performed. Abdomen is closed after hemostasis.
Andere Namen:
  • LADG
Aktiver Komparator: Open Distal Gastrectomy
Conventional standard D2 open distal gastrectomy without omentectomy.
Verfahren: Open distal gastrectomy
Open distal gastrectomy is performed under general endotracheal anesthesia. A long midline incision is made. omentectomy is skipped and D2 lymph node dissection is performed. Anastomosis is done in same manner as LADG. Abdomen is closed after hemostasis
Andere Namen:
  • ODG

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
5 year disease free survival
Zeitfenster: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Laparoscopy assisted distal gastrectomy could be accepted as a oncologically safe and effective treatment if 5 year disease free survival is not inferior compared to open distal gastrectomy. Any recurrence event will be followed up through regular physical and history examinations, imaging by abdominal computed tomography,esophagogastroduodenoscopy and tumor marker like CEA, CA 19-9,and CA 72-4
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Quality of life measured by EORTC QLQ
Zeitfenster: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
EORTC C-30 & Sto-22 engines were measured by self administered questionnaires to compare quality of life between two surgery. Short term evaluation at 3 months, and long term evaluation after 5 years will be done.
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Surgical complications
Zeitfenster: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
Any surgical complications during and after operation will be compared. Long term complications will be monitored also.
1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months
Postoperative surgical outcome
Zeitfenster: within 1 week daily
day of starting bowel movement, day of defevescence, hospital stay, white blood cell counts, C reactive protein, amount of transfusion
within 1 week daily
Overall survival
Zeitfenster: 1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years
Overall survival regardless of cause of death
1week, 1 month, 3 months, 6 months,1 year, 2 years, 3 years,4 years, & 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

National Cancer Center, Korea

Ermittler

  • Hauptermittler: Young-Woo Kim, M.D., Ph.D., National Cancer Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2003

Primärer Abschluss (Tatsächlich)

1. November 2005

Studienabschluss (Tatsächlich)

1. Dezember 2010

Studienanmeldedaten

Zuerst eingereicht

18. Oktober 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Oktober 2007

Zuerst gepostet (Schätzen)

19. Oktober 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

24. Mai 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2012

Zuletzt verifiziert

1. Mai 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • _NCCCTS-052

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