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Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial

Laparoscopy Versus Open Distal Gastrectomy for Early Gastric Cancer: A Randomized Controlled Trial - Laparoscopy-Assisted Distal Gastrectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001513
Enrollment
50
Registered
2013-02-20
Start date
2005-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early gastric cancer

Interventions

Laparoscopy assisted distal gasterctomy Open distal gastrectomy

Sponsors

Kitasato University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients were eligible for inclusion if they were over 20 years of age and under 75 and if they were diagnosed as having gastric cancer in the mid or lower parts of the stomach with indication for distal gastrectomy.

Exclusion criteria

Exclusion criteria: Exclusion criteria were past history of gastric cancer, having received open surgery of the upper abdomen, past history of other types of cancers and cancer treatmentd, serious heart, lung, kidney, blood and/or metabolic diseases, Class III or IV of the New York Heart Association classification of cardiac patients, and Class III of Hugh-Jones dyspnea criteria.

Design outcomes

Primary

MeasureTime frame
The short term primary outcome measure was defined as the intensity of post-operative use of analgesics. Long term primary outcome was overall survival.

Secondary

MeasureTime frame
Short term secondary outcomes were intraoperative and postoperative complication rates, days of post-operative hospitalization, and post-operative inconveniences such as days of fever (> 37 degrees Celsius), days to first flatus, VAS pain scores, and blood loss.

Countries

Japan

Contacts

Public ContactLeon Bax

Kitasato University School of Medicine Kitasato Clinical Research Center

+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026