Laparoscopic Versus Open Gastrectomy for Gastric Cancer

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: Laparoscopic Gastrectomy; Procedure: Open Gastrectomy

• Registration Number: NCT02248519
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-25
• Study Start: 2014-12
• Primary Completion: 2018-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Gastrectomy	Laparoscopic Gastrectomy	Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
Open Gastrectomy	Open Gastrectomy	Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (10)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Zorggroep Twente Almelo; 🇳🇱 Almelo, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Zuyderland Medical Center; 🇳🇱 Sittard-Geleen, Netherlands

Gelre Hospital; 🇳🇱 Apeldoorn, Netherlands

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands