Pilot study of the safety and tolerance of preoperative melatonin application in patients undergoing major liver resection. - PORTAL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005308-15-DE

Enrollment

Registered

2007-02-20

Start date

2007-03-15

Completion date

Unknown

Last updated

2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative infectious complications ICD classification code : T 81.4

Interventions

Product Name: Melatonin Pharmaceutical Form: Powder for oral solution CAS Number: 73314 Other descriptive name: MELATONIN Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and femle patients with liver carcinoma intended for a elective partial liver resection (3 or more segments) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - patients 90 years old - emergency - Patients with severe organ-specific problems like liver or renal insufficiency and acute pancreatitis

Design outcomes

Primary

Measure	Time frame
Main Objective: Testing safety and tolerance of a single, präoperative dosis of Melatonin for patients undergoing large liver resections;Secondary Objective: Group size power calculation for the execution of a clinical efficiency study due to occurred infectious events in the present pilot study ;Primary end point(s): liver enzymes for the evaluation of pathophysiological situations/functions	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026