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Efficacy of Seprafilm for prevention of postoperative adhesions in repeat hepatectomy of recurrent liver tumors. Prospctive Randomized Controlled Trial

Efficacy of Seprafilm for prevention of postoperative adhesions in repeat hepatectomy of recurrent liver tumors. Prospctive Randomized Controlled Trial - Efficacy of Seprafilm in repeat hepatectomy of recurrent liver tumors.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014460
Enrollment
1000
Registered
2014-07-11
Start date
2014-07-11
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

hepatocellular carcinoma or colorectal liver metastases

Interventions

application of Seprafilm after hepatectomy for the treatment of hepatocellular carcinoma or metastatic liver tumors. No application of Seprafilm after hepatectomy for the treatment of hepatocellular

Sponsors

Department of Digestive Surgery, Nihon University School of Medicine
Lead Sponsor
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age over 20 years old at the registration day. 2) ECOG Performance Status is 0-2. 3) Patients with liver damage A or B 4) Patients with primary or secondary hepatectomy scheduled for hepatocellular carcinoma diagnosed by CT imaging 5) Patients with primary or secondary hepatectomy scheduled for the treatment of colorectal liver metastases in our department. 6) The history of prior local therapy are permitted if liver tumor are resectable. 7) Patients have enough organ function for study treatment within 14 days before registration. - neutrophil count: >=2,000/mm3, <=10,000 /mm3 - platelet: >=50,000/mm3 - serum bilirubib level: <=1.5mg/dL - PT(%): >=50% - serum creatinine level: <=1.5mg/dL - AST: <=100IU/L - ALT: <=100IU/L - albumin: >=3.0g/dL 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Severe comorbidity 2) Severe infectious disease 3) Pleural effusion, ascites fluid and the pericardial fluid needing treatment 4) Patients with other primary malignancies. 5) A past history of drug allergy (needs continuation therapy) 6) Chronic systemic treatment of corticosteroid 7) Bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant 8) Patients infected with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). 9) Patients during pregnancy, breast- feeding, or at risk of becoming pregnant. 10) Psychological disorder 11) Considered not appropriate for surgery 12) Patients considered inappropriate by the study investigator

Design outcomes

Primary

MeasureTime frame
adhesion time needed for dissecting the adhesions in reoperation of the liver in future

Countries

Japan

Contacts

Public ContactKanamoto Akira

Nihon University School of Medicine Department of Digestive Surgery

kanamoto.akira@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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