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Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation
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This study investigates if the administration of terlipressin reduces complications after major liver surgery.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terlipressin | Active Comparator | Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg). |
|
| NaCl | Placebo Comparator | Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with incident of a composite end point | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with pleural effusion | one month | |
| Number of patients with surgical site infection | one month | |
| Number of patients with sepsis |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Guido Beldi, Professor Dr. med. | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Visceral Surgery, University Hospital Berne | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31680011 | Derived | 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. |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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| Placebo | Drug | Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours). |
|
| one month |
| Number of patients with pneumonia | one month |
| Number of patients with intraabdominal hematoma | one month |
| Number of patients with acute renal failure | one month |
| Number of patients with blood transfusion | one month |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |