Somatostatin in Living Donor Liver Transplantation

NCT04107428 | Unknown Phase 4

• 1 other identifier: C380/981/40
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim of the study is to investigate the safety and the efficacy of somatostatin as liver inflow modulator in patients with end-stage liver disease (ESLD) and clinically significant portal hypertension (CSPH) undergoing Adult-to-Adult living donor liver transplantation (A2ALDLT).

Conditions

End Stage Liver DIsease; Portal Hypertension

Keywords

adult-to-adult living donor liver transplantation; small-for-size syndrome; graft hyperperfusion

Outcome Measures

Primary Outcomes (1)

• Portal venous flow changes

  Flow measured with transit time flow measurement system

  Day 0 - At the end of liver transplantation surgery, before skin closure

Secondary Outcomes (8)

• Rate of patients presenting a significant portal venous flow reduction (-20%)

  Day 0 - At the end of liver transplantation surgery, before skin closure

• Rate of patients requiring surgical inflow modulation

  Day 0 - At the end of liver transplantation surgery, before skin closure

• Changes in hepatic artery flow

  Day 0 - At the end of liver transplantation surgery, before skin closure

• Incidence of Small-for-size syndrome

  30 days

• Changes in postoperative portal venous flow

  Postoperative day 1, 7 and 14

Study Arms (2)

Somatostatin

ACTIVE COMPARATOR

Drug: Somatostatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Somatostatin DRUG

A bolus of 5cc of saline containing 500 mcg of somatostatin will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 250 mcg per hour of somatostatin (infusion rate 2.5 cc/hour) for 10 days.

Somatostatin

Placebo DRUG

A bolus of 5cc of saline will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 2.5 cc of saline/hour for 10 days.

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patients (\> 18 years old) undergoing Adult-to-Adult Living donor Liver Transplantation (LDLT) (right or left lobe)
• Indication for LDLT: End Stage Liver Disease with Portal Hypertension (HVPG ≥ 10mmHg)

You may not qualify if:

• Complete portal vein thrombosis (pre-operative or intraoperative diagnosis)
• Hepatopulmonary hypertension
• Adult-to-Adult Living donor liver transplantation for Fulminant hepatic failure
• Recipients of multiple solid organ transplants
• History of cardiac arrhythmias

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead
• Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy: collaborator
• CEINGE - Biotecnologie Avanzate, Napoli, Italia: collaborator

MeSH Terms

Conditions

End Stage Liver Disease; Hypertension, Portal

Interventions

Somatostatin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; 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

• Roberto Troisi, MD, PhD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

• Dieter Broering, MD, PhD

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Troisi, MD, PhD

CONTACT

+966(0)11-4482123; roberto.troisi@unina.it

Kris Hervera Marquez

CONTACT

.: (+966-11) 4647272; krhervera@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: Randomized double-blinded placebo-controlled trial

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 27, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: February 1, 2022
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share