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Sponsor: UMC Utrecht
Conditions: Gastric Cancer
Interventions: Open Gastrectomy, Laparoscopic Gastrectomy
Countries: Netherlands
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically proven adenocarcinoma of the stomach * Surgically resectable (cT1-4a, N0-3b, M0) tumor * Age ≥ 18 years * European Clinical Oncology Group (ECOG) performance status 0, 1 or 2. * Written informed consent Exclusion Criteria: * Siewert type I esophagogastric junction tumor * Non-elective surgery * Previous gastric resection or recurrent gastric cancer * Pregnancy
- Almelo, Netherlands
- Amersfoort, Netherlands
- Amsterdam, Netherlands
- Amsterdam, Netherlands
- Apeldoorn, Netherlands
- Eindhoven, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- Sittard-Geleen, Netherlands
- Utrecht, Netherlands