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NCT Number: NCT02248519

Laparoscopic Versus Open Gastrectomy for Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zorggroep Twente Almelo, Almelo, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open gastrectomy

Procedure

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

Laparoscopic Gastrectomy

Procedure

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.

Primary outcomes

  1. Post-operative hospital stay

    Time frame: 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 outcomes

  1. Mortality

    Time frame: 30 days post-operative

    Measured as 30-day mortality rate

  2. Post-operative morbidity

    Time frame: 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

  3. Cost-effectiveness

    Time frame: 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

  4. Quality of Life

    Time frame: 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.

  5. Readmissions

    Time frame: Up to 5 years post-operative

    The number of post-operative readmissions

  6. Oncologic outcomes (R0-resection rate and lymph node yield)

    Time frame: 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.

Other outcomes

  1. Perioperative blood loss

    Time frame: Post-operative day 1

    Measured in milliliters (ml)

  2. Operative time

    Time frame: Post-operative day 1

    The time from incision to closure of all wounds in minutes (min)

  3. Conversion rate

    Time frame: Post-operative day 1

    The percentage (%) of laparoscopic gastrectomies that had to be converted intra-operatively to an open procedure due to any reason.

  4. Survival

    Time frame: Up to 5 years post-operative

    Measured as 5-year disease free survival and 5-year overall survival

  5. VAS-score

    Time frame: Post-operative day 1 and 2

  6. Surgeons ergonomics

    Time frame: Post-operative day 1

    Measured with the Subjective Mental Effort Questionnaire (SMEQ)

  7. Time to return to normal nutritional regime

    Time frame: Up to 5 years post-operative

  8. Time to return to daily activity

    Time frame: Up to 5 years post-operative

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Johnson & Johnson
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: LOGICA

Important dates

Study start
2014
Primary completion
2018
Study completion
2023
First posted
Sep 25, 2014
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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