Laparoscopic Versus Open Gastrectomy for Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric cancer, Gastrectomy, Laparoscopy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Open Gastrectomy Type: Procedure
Name: Laparoscopic Gastrectomy Type: Procedure
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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

- Pregnancy
Locations
Academic Medical Center
Amsterdam, Netherlands
Status: Not yet recruiting
Contact: Suzanne S Gisbertz, MD PhD - S.S.Gisbertz@amc.uva.nl
VU University Medical Center
Amsterdam, Netherlands
Status: Not yet recruiting
Contact: Donald L van der Peet, MD PhD - DL.vanderPeet@vumc.nl
Rijnstate Hospital
Arnhem, Netherlands
Status: Not yet recruiting
Contact: Ernst J Spillenaar Bilger, MD PhD - ESpillenaarBilgen@alysis.nl
Catharina Hospital
Eindhoven, Netherlands
Status: Not yet recruiting
Contact: Misha DP Luyer, MD PhD - Misha.Luyer@cze.nl
Leiden University Medical Center
Leiden, Netherlands
Status: Not yet recruiting
Contact: Wobbe O de Steur, MD PhD - W.O.deSteur@lumc.nl
Erasmus Medical Center
Rotterdam, Netherlands
Status: Not yet recruiting
Contact: Bas PL Wijnhoven, MD PhD - B.Wijnhoven@erasmusmc.nl
Orbis Medical Center
Sittard-Geleen, Netherlands
Status: Not yet recruiting
Contact: Jan HM Stoot, MD PhD - J.Stoot@orbisconcern.nl
University Medical Center Utrecht
Utrecht, Netherlands
Status: Recruiting
Contact: Richard van Hillegersberg, MD PhD - +31 (0)88-755 8074 - r.vanhillegersberg@umcutrecht.nl
Start Date
December 2014
Completion Date
January 2023
Sponsors
UMC Utrecht
Source
UMC Utrecht
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page