Laparoscopic Versus Open Gastrectomy for Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Versus Open Gastrectomy for Gastric Cancer, a Multicenter Prospectively Randomized Controlled Trial (LOGICA-trial)

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Open Gastrectomy
* Procedure: Laparoscopic Gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Gastrectomy<br>Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group | Procedure: Open Gastrectomy<br>* Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group<br>|
| Experimental: Laparoscopic Gastrectomy<br>Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. | Procedure: Laparoscopic Gastrectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hospital stay | 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. | During admission, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Measured as 30-day mortality rate | 30 days post-operative | 
| Post-operative morbidity | 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 | Up to 5 years post-operative | 
| Cost-effectiveness | Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation | Up to 5 years post-operative | 
| Quality of Life | 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. | Up to 5 years post-operative | 
| Readmissions | The number of post-operative readmissions | Up to 5 years post-operative | 
| Oncologic outcomes (R0-resection rate and lymph node yield) | 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. | Pathology report 1-2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Gastrectomy, Laparoscopy