Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)

Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III) - Randomized Controlled Trial to Evaluate Laparoscopic versus Open Surgery for Advanced Gastric Cancer (JLSSG0901: Adv.GC-LAP/OPEN, PII/III)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003420

Enrollment

500

Registered

2010-03-31

Start date

2009-11-01

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

Advanced gastric cancer

Interventions

A: Open distal gastrectomy with D2 lymph node dissection B: Laparoscopy assisted distal gastrectomy with D2 lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For inclusion in the study, patients must fulfill the following requirements preoperatively: 1) histologically proven gastric carcinoma 2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system 3) tumor located in the body and antrum of the stomach and indication for distal gastrectomy 4)No invasion to duodenum 5) Aged 20 to 80 year 6) PS (ECOG)0 or 1 7) Body mass index < 30 8) no history of gastrointestinal surgery 9) no history of chemotherapy or radiotherapy 10) Sufficient organ functions 11) provided written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ. 2) Women during pregnancy or breast-feeding. 3) Severe mental disease. 4) Continuous systemic steroid therapy. 5) History of myocardial infarction or unstable angina pectoris within six months. 6) Uncontrollable hypertension. 7) Uncontrollable diabetes millutus or administration of insulin. 8) Severe respiratory disease requiring continuous oxygen therapy.

Design outcomes

Primary

Measure	Time frame
phaseII: Incidence of anastomotic leakage or pancreatic fistula phaseIII:relapse-free survival	—

Secondary

Measure	Time frame
overall survival, proportion of LADG completion, proportion of conversion to open surgery, adverse events, short-term clinical outcomes, number of retrieved lymph node, recurrent sites	—

Countries

Japan

Contacts

Public ContactTsuyoshi Etoh

Japanese Laparoscopic Surgery Study Group (JLSSG) Coordinating Office Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine

geka1@oita-u.ac.jp097-586-5843

Outcome results

None listed

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