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The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial

The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial - No drain policy in liver surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017608
Enrollment
400
Registered
2015-05-18
Start date
2015-06-05
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

Elective hepatic resection without biliary reconstruction

Interventions

Placement of abdominal drain Absent of abdominal drain

Sponsors

Hepatobiliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Undergoing elective hepatic resection without biliary reconstruction 2) ECOG performance status: 0-2 3) Unimpaired organ function: 1. WBC >= 2,000/mm3 2. Plt >= 50,000/mm3 3. T.Bil <= 2.0 mg/dL 4. Cre <= 1.5 mg/dL 4) Age: 20 years or older 5) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Concomitant resection of other organs excluding gallbladder 2) Administration of anti-coagulant drug just before the operation 3) Schedule to administrate anti-coagulant drug by 3 days after operation 4) Psychiatric disorder 5) Pregnant 6) Supposed extremely high risk of biliary leakage or bleeding after operation because of area of hepatic transection, and exposure of Glisson sheath on transection surface 7) C-tube placement 8) Thoracic tube placement

Design outcomes

Primary

MeasureTime frame
Frequency of postoperative complication at or greater than Clavien-Dindo grade 3

Secondary

MeasureTime frame
Wound-related complication, total postoperative complication, biliary leakage, inflammatory indicator in blood and serum examination, duration of postoperative hospital stay

Countries

Japan

Contacts

Public ContactJunichi Arita

Graduate School of Medicine, University of Tokyo Hepatobiliary-Pancreatic Surgery Division, Department of Surgery

jarita-tky@umin.ac.jp+81-3-3815-5411

Outcome results

None listed

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