Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA)

UMC Utrecht

Status: Unknown

Conditions: Gastric Cancer

Treatments: Procedure: Open Gastrectomy; Procedure: Laparoscopic Gastrectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02248519

NL47444.041.14

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Open Gastrectomy

Active Comparator group

Description:

Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group

Treatment:

Procedure: Open Gastrectomy

Laparoscopic Gastrectomy

Experimental group

Description:

Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.

Treatment:

Procedure: Laparoscopic Gastrectomy