Safety and efficacy of postoperative enoxaparin treatment in patients undergoing curative hepatobiliary-pancreatic cancer surgery: a prospective, Phase Two, multi-center study

Phase 2

• Conditions: hepatobiliary-pancreatic cancer

• Registration Number: JPRN-jRCT1051190020
• Lead Sponsor: Kobayashi Syogo

Brief Summary

After surgery for hepatobiliary-pancreatic cancer, the rate of venous thromboembolism in enoxaparin group was 1.7% compared with that in control group (3.4%). In this study, subcutaneous administration of enoxaparin after surgery did not prevent the onset of venous thromboembolism.It may be considered as one of the preventive measures in the future.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Study Completion: 2022-08-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

1,Hepatobiliary-pancreatic cancer with surgical resection.(excluded foe pancreatoduodenectomy or hepatic resection with biliary reconstruction)
2,Aged 40 over years old.
3,Expected for survival of more than 6 months after surgery.
4,Child-Pugh A
5,Informed Consent

Exclusion Criteria

1 Symptom of deep venous thrombus.
2 Treatment of estrogen or progesterone within 4 weeks before administration.
3 Chemotherapy or radiotherapy within 2 weeks before administration.
4 Receiving anticoagulant (heparin or warfarin), anti-platelet therapy,
aspirin from 2 days before the operation
5 Severe renal dysfunction (less than 30 mL/min of creatinine clearance)
6 Platelet count < 75000/mm^2,
7 APTT > 50
8 History of thrombocytopenia caused by heparin.
9 History of surgery for eye, spinal or central nerve system within 2 weeks.
10 History of peptic ulcer or bleeding within 3 months
11 History of cerebral hemorrhage within 1 year
12 History of allergy for heparin or biological products.
13 Patients with acute bacterial endocarditis
14 Pregnancy
15 others, in the investigator's judgment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of venous thromboembolism

Secondary Outcome Measures

Name	Time	Method
Rate of bleeding (major or minor bleeding within 30 days)<br>Rate of adverse event