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A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer

A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer - A phase II study of laparoscopy assisted total / proximal gastrectomy for gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014924
Enrollment
50
Registered
2014-08-22
Start date
2009-09-01
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

cStage I gastric cancer

Interventions

Laparoscopy assisted total and proximal gastrectomy

Sponsors

Aichi Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenocarcinoma. 2) cStage IA or IB. 3) No indication of endoscopic mucosal resection (EMR) in a cN0 case. 4) Tumor located in the upper 1/3 of the stomach and indication for total or proximal gastrectomy. 5) No invasion to duodenum. 6) Aged 20 to 85 year. 7) Body mass index <30. 8) 13) 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. 8) Severe respiratory disease requiring continuous oxygen therapy.

Design outcomes

Primary

MeasureTime frame
Incidence of anastomotic leakage

Secondary

MeasureTime frame
proportion of LAG completion, proportion of conversion to open surgery, proportion of anastomotic stenosis, Incidence of anastomotic stenosis, pancreatic fistula or peritoneal abscess, overall survival, recurrence-free survival, adverse events, short-term clinical outcomes

Countries

Japan

Contacts

Public ContactKazunari Misawa

Aichi Cancer Center Hospital Department of Gastroenterological Surgery

misawakzn@aichi-cc.jp0527626111

Outcome results

None listed

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