Clinical trial NCT01921985: Terlipressin Administration in Patients Undergoing Major Liver Resection
Official title: Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Resection
Liver Failure
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates if the administration of terlipressin reduces complications after major liver surgery.

Detailed description: Background

Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration.

Objective

Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.

Methods

Eligibility criteria: Inclusion Criteria:

* Patients undergoing resection of 3 or more liver segments
* Minimum age of 18
* Any gender
* Written informed consent

Exclusion Criteria

* Preoperative renal failure (GFR \< 50ml/min)
* Severe liver dysfunction (Child-Turcotte-Pugh grade C)
* Hyponatremia (\<132mmol/l)
* Severe aortic regurgitation, severe mitral regurgitation, heart failure
* Symptomatic coronary heart disease
* Bradycardic arrhythmia (heart rate \< 60/min)
* Peripheral artery occlusive disease (clinical stadium II-IV)
* Dilatative arteriopathy, history of subarachnoidal bleeding
* Decompensated arterial hypertension (Blood pressure \>160/100mmHg despite intensive treatment)
* Present or suspected acute mesenteric ischemia
* Septic shock
* Pregnancy

Primary outcomes:
measure: Number of patients with incident of a composite end point
timeFrame: one month
Secondary outcomes:
measure: Number of patients with pleural effusion
timeFrame: one month
measure: Number of patients with surgical site infection
timeFrame: one month
measure: Number of patients with sepsis
timeFrame: one month
measure: Number of patients with pneumonia
timeFrame: one month
measure: Number of patients with intraabdominal hematoma
timeFrame: one month
measure: Number of patients with acute renal failure
timeFrame: one month
measure: Number of patients with blood transfusion
timeFrame: one month
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Dep. of Visceral Surgery, University Hospital Berne
Study officials:
affiliation: University of Bern
name: Guido Beldi, Professor Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohler A, Perrodin S, De Gottardi A, Candinas D, Beldi G. Effectiveness of terlipressin for prevention of complications after major liver resection - A randomized placebo-controlled trial. HPB (Oxford). 2020 Jun;22(6):884-891. doi: 10.1016/j.hpb.2019.10.011. Epub 2019 Oct 31.