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AzTrials

Gastric CancerLOGICANCT02248519

Laparoscopic Versus Open Gastrectomy for Gastric Cancer

A study testing Open Gastrectomy and Laparoscopic Gastrectomy in people with Gastric Cancer, run by UMC Utrecht at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Open Gastrectomy and Laparoscopic Gastrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
10 sitesNetherlands
Study dates
1 Dec 2014to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Siewert type I esophagogastric junction tumor
  • Non-elective surgery
  • Previous gastric resection or recurrent gastric cancer
  • Pregnancy

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Netherlands10 sites

  • Zorggroep Twente Almelo

    Almelo

  • Meander Medical Center

    Amersfoort

  • VU University Medical Center

    Amsterdam, 1081 HZ

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • Gelre Hospital

    Apeldoorn

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Leiden University Medical Center

    Leiden, 2333 ZA

  • Erasmus Medical Center

    Rotterdam, 3015 CE

  • Zuyderland Medical Center

    Sittard-Geleen, 6162 BG

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

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

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.

Conditions
Gastric Cancer
Being tested
Open Gastrectomy, Laparoscopic Gastrectomy
Keywords
Gastric cancer, Gastrectomy, Laparoscopy
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open GastrectomyProcedure or surgery

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

  • Laparoscopic GastrectomyProcedure or surgery

    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.

Study groups in NCT02248519
Study groupRoleWhat they receive
Open GastrectomyActive comparatorPatients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Receives: Procedure: Open Gastrectomy
Laparoscopic GastrectomyExperimentalPatients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
Receives: Procedure: Laparoscopic Gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During admission, an expected average of 2 weeks

Secondary outcomes (6)

  1. Mortality

    Measured as 30-day mortality rate

    Measured: 30 days post-operative

  2. 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

    Measured: Up to 5 years post-operative

  3. Cost-effectiveness

    Cost-effectiveness will be calculated by comparing the direct medical cost related to both strategies up until five years after the operation

    Measured: Up to 5 years post-operative

  4. 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.

    Measured: Up to 5 years post-operative

  5. Readmissions

    The number of post-operative readmissions

    Measured: Up to 5 years post-operative

  6. 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.

    Measured: Pathology report 1-2 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study start1 Dec 2014
  3. Primary completion1 Nov 2018
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02248519
Sponsor's protocol ID
NL47444.041.14
Acronym
LOGICA
Status last verified
Feb 2026
First submitted
17 Sep 2014
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Individual participant data that underlie the results reported in the primary manuscript will be shared after de-identification (text, tables, figures, and appendices).

Publications

  • 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.

    PubMed 26219670

  • van 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.

    PubMed 37464143

  • de 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.

    PubMed 37340107

  • van 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.

    PubMed 34581617

Questions about this trial

What is this clinical trial studying?

A study testing Open Gastrectomy and Laparoscopic Gastrectomy in people with Gastric Cancer, run by UMC Utrecht at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative hospital stay (time frame: During admission, an expected average of 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02248519, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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