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A randomized phase II study to evaluate the prolonged prophylactic antibacterial drug treatment for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection

A randomized phase II study to evaluate the prolonged prophylactic antibacterial drug treatment for patients with elevated drain-amylase concentration after gastrectomy with D2 lymph node dissection - REDUCED2

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012152
Enrollment
100
Registered
2013-11-01
Start date
2013-11-01
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

Gastric Cancer

Interventions

Prophylactic antibacterial drug only for the operative day Prophylactic antibacterial drug until the 7th postoperative day

Sponsors

Shizuoka Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Biopsy specimen from the primary lesion shows adenocarcinoma 2) R0 resection or R1 resection with CY1 by gastrectomy with D2 lymph node dissection 3) The maximum value of drain amylase concentration is above 3000 (IU/L) 4) Esophageal invasion is less than 3cm. 5) Eeatern clinical oncology group performans status is 0 or 1 6) No previous chemotherapy or radiation including those for other cancers 7) Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl 8) written informed consent

Exclusion criteria

Exclusion criteria: 1) Having other active infectious disease 2) combined resection (gall bladder and spleen are exceptions) 3) Possibly pregnant, or breast feeding woman 4) with psychiatric disorder 5) Receiving steroids 6) With Acute myocardial infaction in 6 months or with unstable ungina 7) With uncontrolled hypertention 8) With uncontrolled diabetes mellitus 9) With pulmonary disease and require continuous oxygen therapy 10) With allergy to cephalosporin

Design outcomes

Primary

MeasureTime frame
The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)

Countries

Japan

Contacts

Public ContactYuichiro Miki

Shizuoka Cancer Center Gastric Surgery

y.miki@scchr.jp055-989-5222

Outcome results

None listed

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