The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection

NCT04010669 | Unknown Phase 3 DMC

• 1 other identifier: Somatostatin trial
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of velocity and blood flow of the hepatic circulation in patients undergoing liver resection. The patients will be randomized in two groups: the study group will receive somatostatin and the control group will receive the placebo. In both groups, patients will undergo hepatectomy and directly postoperatively they will receive either somatostatin or placebo, depending on their randomization. The primary endpoint will be the increase or decrease of the velocity and the flow of the hepatic circulation estimated by ultrasonography compared to the same parameters when measured preoperatively.

Conditions

Portal Hypertension

Keywords

Portal Hypertension; Liver resection; Somatostatin

Outcome Measures

Primary Outcomes (3)

• The effect of somatostatin in the regulation of velocity of the hepatic circulation at patients who have undergone hepatectomy.

  The velocity of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically

  7 days

• The effect of somatostatin in the regulation of diameter of the vessels of the hepatic circulation at patients who have undergone hepatectomy.

  The diameter of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically

  7 days

• The effect of somatostatin in the regulation of blood flow of the hepatic circulation at patients who have undergone hepatectomy.

  The blood flow of the portal vein, splenic vein, hepatic artery and hepatic veins will be calculated using the following mathematic formula: Flow= velocity x cross section area (the cross section area of the vessel can be calculated using the following equation: CSA=πr2, with 'r' representing the vessel's radius).

  7 days

Study Arms (2)

Study group

ACTIVE COMPARATOR

The study group includes participants who will receive somatostatin postoperatively (after liver resection).

Drug: Somatostatin

Control group

PLACEBO COMPARATOR

The control group includes participants who will receive placebo (a 24 hours infusion of 1000ml Normal Saline solution 0.9%) postoperatively (after liver resection).

Drug: Placebo

Interventions

Somatostatin DRUG

2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days

Study group

Placebo DRUG

24 hours infusion of 1000ml Normal Saline solution 0.9%

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing hepatectomy for any reason including primary malignant liver tumors (hepatocellular carcinomas, cholangiocellular carcinomas, etc), metastatic liver disease and symptomatic benign liver lesions (liver adenomas, focal nodular hyperplasia, hemangiomas, etc).
• Adult patients (≥18 years old)
• Patients whose indication for hepatectomy will be decided by a multidisciplinary team meeting.
• Patients who eill agree to sign an informed consent

You may not qualify if:

• Patients undergoing synchronous hepatectomy-colectomy.

Sponsors & Collaborators

• Laikο General Hospital, Athens: lead

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Georgios C Sotiropoulos, MD, PhD

  Assistant Professor of Surgery, Laiko Hospital

  STUDY CHAIR

Central Study Contacts

Evgenia C Kotsifa, MD

CONTACT

00306986640874; eugeniakotsifa@yahoo.gr

Georgios C Sotiropoulos, MD, PhD

CONTACT

00306948111291; gsotirop@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 8, 2019
• Study Start: August 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07