Gastric Cancer
Conditions
Keywords
Gastric cancer, Gastrectomy, Laparoscopy
Brief 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.
Interventions
PROCEDUREOpen Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
PROCEDURELaparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.
Sponsors
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Johnson & Johnson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative hospital stay | During admission, an expected average of 2 weeks | The primary outcome of this study is the post-operative hospital stay (days), since this is considered a strong end point as it reflects the impact of the different surgical procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days post-operative | Measured as 30-day mortality rate |
| Post-operative morbidity | Up to 5 years post-operative | Complications will be classified according to the Clavien-Dindo system and include anastomotic leakage, anastomotic stricture, respiratory complications, cardiac complications, intra-abdominal bleeding , intra-abdominal abscess, sepsis, ileus, wound infection, fistula, urinary tract infection and dumping syndrome |
| Cost-effectiveness | Up to 5 years post-operative | Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation |
| Quality of Life | Up to 5 years post-operative | The validated quality of life questionnaires EORTC QLQ-30, EORTC QLQ-STO22 and EQ-5D-5L, will be filled in pre-operative \<5 days and post-operative at 6 weeks, 12, 24, 36, 48 and 60 months after surgery. |
| Readmissions | Up to 5 years post-operative | The number of post-operative readmissions |
| Oncologic outcomes (R0-resection rate and lymph node yield) | Pathology report 1-2 weeks after surgery | R0-resection rate of the distal and proximal margin, defined according to the College of American Pathologists. Lymph node yield: the amount of harvested lymph nodes per patient. |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORRichard van Hillegersberg, MD PhD
Dept. of Surgery, University Medical Center Utrecht
Outcome results
None listed