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Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication

Single arm clinical study of preoperative bile replacement for jaundiced patients : phase II traial to investigate the relationship to perioperative complication - Phase II study of preoperative bile replacement

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000014828
Enrollment
40
Registered
2014-09-01
Start date
2014-09-01
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

Biliary tract cancer and pancreatic cancer

Interventions

None listed

Sponsors

Kobe university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Performance Status 0-1 Patients over 20 years of age to 80 years Patients with Pancreas or biliary tract cancer without multiple organ failure. Patients with serum total bilirubin levels greater than 3.0mg/dl.

Exclusion criteria

Exclusion criteria: Patients who do not agree with this study. Patients with cirrhosis or active hepatitis. Patients with severe cardiac or respiratory disease. Patients who receive hemodialysis. Patients with pregnant. Patients with cancer in other organs. Patients who were deemed inappropriate by the attending physician.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative infectious complications

Secondary

MeasureTime frame
Cellular immunity and intestinal integrity( Concanavalin A, Phytohemagglutin, Diamine oxydase activity)

Countries

Japan

Contacts

Public ContactTetsuo Ajiki

Kobe university hospital Hepato biliary pancreatic surgery

ajiki@med.kobe-u.ac.jp078-382-6302

Outcome results

None listed

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