Laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay
ID
Bron
Verkorte titel
Aandoening
Gastric Cancer, Gastrectomy, Laparoscopy
Maagkanker, Maagresectie, Laparoscopie
Ondersteuning
Johnson & Johnson
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Hospital stay
Achtergrond van het onderzoek
For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of multi-modality treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, these studies were predominantly based on Asian populations, which show significant differences compared to Western populations. In this randomized controlled trial laparoscopic and open gastrectomy are compared in a Western population.
The design of the study is a non-blinded multicenter prospectively randomized controlled, superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be informed and included at the surgical outpatient department at one of the eight participating Dutch investigational centers and randomized to either laparoscopic or open gastrectomy. The primary outcome of this study is post-operative hospital stay (days).
This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.
Doel van het onderzoek
Laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay
Onderzoeksopzet
- Hospital stay (in days). Timepoint: on discharge
- Post-operative morbidty (Clavien-Dindo). Timepoint: 5 years post-operative
- Mortality (1- and 5-year disease free survival rate). Timepoint: 5 years post-operative
- Readmissions (number of). Timepoint: 5 years post-operative
- Oncologic outcome (lymph nodes harvested and R0-resection rate). Timepoint: pathology report
- Quality of life (SF-36, EORTC QLQ-30 and EORTC QLQ-STO22). Timepoint: 6 weeks, 6, 12, 24, 36, 48, 60 months post-operative
- Cost-effectiveness (direct medical cost related to both strategies). Timepoint: 5 years post-operative
Onderzoeksproduct en/of interventie
Laparoscopic or Open procedure for Total or Distal Gastrectomy
Publiek
Dept. of Surgery, G04.228
University Medical Center Utrecht
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88-755 8074
leonie.haverkamp@gmail.com
Wetenschappelijk
Dept. of Surgery, G04.228
University Medical Center Utrecht
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88-755 8074
leonie.haverkamp@gmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Histologically proven adenocarcinoma of the stomach
• Surgically resectable (cT1-4a, N0-3b, M0) tumor
• Age ≥ 18 years
• ECOG performance status 0,1 or 2.
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria
• Siewert type I esophago-gastric junction tumor
• Prior gastric surgery
• Pregnancy
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4616 |
| NTR-old | NTR4767 |
| CCMO | NL47444.041.14 |
| OMON | NL-OMON47143 |
Samenvatting resultaten
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