To evaluate the benefits, risks and costs of laparoscopic gastrectomy as an alternative to open gastrectomy (gold standard) as treatment for gastric cancer in a Western population.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is postoperative hospital stay (days).
Secondary outcome
Secondary outcomes are cost-effectiveness, oncologic outcomes, postoperative
morbidity, mortality, and quality of life.
Background summary
Gastric cancer is a life-threatening disease with an incidence of 2.000 in the
Netherlands. Surgical resection is the cornerstone of curative treatment. In
the Netherlands this procedure is mainly performed by open surgery, whereas our
recent meta-analysis of cohort studies showed that laparoscopic gastrectomy is
associated with reduced intraoperative blood loss, reduced postoperative
complications and shorter hospital stay. These benefits were at the cost of
longer operative time. However, thus far all studies were performed in an Asian
population containing a large percentage of T1-2 tumors. There is no RCT in a
Western population with locally advanced gastric cancer. In the Netherlands
experience with laparoscopic gastrectomy has increased in the last years, with
now more than 5 centers performing this type of operation on a routine basis.
We have trained this technique to 30 surgeons visiting our Minimally Invasive
Gastrectomy course in the past 2 years.
Study objective
To evaluate the benefits, risks and costs of laparoscopic gastrectomy as an
alternative to open gastrectomy (gold standard) as treatment for gastric cancer
in a Western population.
Study design
Multicenter prospectively randomized controlled trial
Intervention
Laparoscopic versus open gastrectomy.
Study burden and risks
Patients will undergo either laparoscopic gastrectomy (experimental arm) or the
conventional open gastrectomy (gold standard). Tumor biopsies will be collected
pre-operatively. Blood samples will be drawn preoperative, at baseline and on
postoperative day 1 and 2. Patients are required to fill out quality of life
questionnaires (preoperatively and <5 days, 6 weeks, 3, 6 and 9 months, and
yearly up to 5 years postoperatively). Laparoscopic gastrectomy was
demonstrated to be safe in our own series of 30 patients treated in the UMC
Utrecht as well as in our recent meta-analysis of the literature.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
• Histologically proven gastric adenocarcinoma
• Surgically resectable (cT1-4a, N0-3b, M0) tumor
• Mentally capable patient
• Age >= 18
• European Clinical Oncology Group (ECOG) performance status 0,1 or 2
• Written informed consent
Exclusion criteria
• Siewert type I junction tumor (tumor located <=5 cm proximal from the esophagogastric junction)
• Pregnant women
• Mentally incompetent patients
• Non-elective surgery
• Previous gastric resection or recurrent gastric cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02248519 |
| CCMO | NL47444.041.14 |
| OMON | NL-OMON21049 |