Laparoscopic Versus Open Gastrectomy for Gastric Cancer
LOGICA
1 other identifier
interventional
210
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Dec 2014
Longer than P75 for not_applicable gastric-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFebruary 19, 2026
February 1, 2026
3.9 years
September 17, 2014
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Mortality
30 days post-operative
Post-operative morbidity
Up to 5 years post-operative
Cost-effectiveness
Up to 5 years post-operative
Quality of Life
Up to 5 years post-operative
Readmissions
Up to 5 years post-operative
- +1 more secondary outcomes
Other Outcomes (8)
Perioperative blood loss
Post-operative day 1
Operative time
Post-operative day 1
Conversion rate
Post-operative day 1
- +5 more other outcomes
Study Arms (2)
Open Gastrectomy
ACTIVE COMPARATORPatients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Laparoscopic Gastrectomy
EXPERIMENTALPatients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
Interventions
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.
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Siewert type I esophagogastric junction tumor
- Non-elective surgery
- Previous gastric resection or recurrent gastric cancer
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Johnson & Johnsoncollaborator
Study Sites (10)
Zorggroep Twente Almelo
Almelo, Netherlands
Meander Medical Center
Amersfoort, Netherlands
VU University Medical Center
Amsterdam, 1081 HZ, Netherlands
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Gelre Hospital
Apeldoorn, Netherlands
Catharina Hospital
Eindhoven, 5623 EJ, Netherlands
Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
Erasmus Medical Center
Rotterdam, 3015 CE, Netherlands
Zuyderland Medical Center
Sittard-Geleen, 6162 BG, Netherlands
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Related Publications (4)
Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z.
PMID: 26219670BACKGROUNDvan der Veen A, Ramaekers M, Marsman M, Brenkman HJF, Seesing MFJ, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, de Steur WO, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA study group. Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial). J Gastrointest Surg. 2023 Oct;27(10):2057-2067. doi: 10.1007/s11605-023-05728-3. Epub 2023 Jul 18.
PMID: 37464143DERIVEDde Jongh C, van der Veen A, Brosens LAA, Nieuwenhuijzen GAP, Stoot JHMB, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Distal Versus Total D2-Gastrectomy for Gastric Cancer: a Secondary Analysis of Surgical and Oncological Outcomes Including Quality of Life in the Multicenter Randomized LOGICA-Trial. J Gastrointest Surg. 2023 Sep;27(9):1812-1824. doi: 10.1007/s11605-023-05683-z. Epub 2023 Jun 20.
PMID: 37340107DERIVEDvan der Veen A, Brenkman HJF, Seesing MFJ, Haverkamp L, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, Lagarde SM, de Steur WO, Hartgrink HH, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial. J Clin Oncol. 2021 Mar 20;39(9):978-989. doi: 10.1200/JCO.20.01540. Epub 2021 Jan 6.
PMID: 34581617DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard van Hillegersberg, MD PhD
Dept. of Surgery, University Medical Center Utrecht
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
September 17, 2014
First Posted
September 25, 2014
Study Start
December 1, 2014
Primary Completion
November 1, 2018
Study Completion
December 1, 2023
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- Immediately following publication; no end date.
- Access Criteria
- Anyone who wishes to access the data for any purpose.
Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).