Laparoscopic Versus Open Gastrectomy for Gastric Cancer

Not Applicable

• Conditions: Gastric Cancer

• 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

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)

Zorggroep Twente Almelo; 🇳🇱 Almelo, Netherlands

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Gelre Hospital; 🇳🇱 Apeldoorn, Netherlands

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Zuyderland Medical Center; 🇳🇱 Sittard-Geleen, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands