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

Sponsor

Laikο General Hospital, Athens (Other)

Overall Status

Unknown status

CT.gov ID

NCT04010669

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Portal Hypertension	Drug: Somatostatin Drug: Placebo	Phase 3

Detailed Description

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of blood flow of the portal circulation at patients who have undergone hepatectomy. The patients will be randomized in two groups, namely the group that will receive somatostatin (study group) and the group that will receive the placebo (control group). In both groups, patients will undergo liver resection and directly postoperatively they will receive either somatostatin (2 amps at 1000ml normal saline solution in continuous 24-hour infusion for 5 days) or a 24 hours infusion of 1000ml Normal Saline solution 0.9%. On the first, third, fifth and seventh postoperative day, the velocity and the diameter of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically and the flow 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: cross section area=πr2, with 'r' representing the vessel's radius).

Preoperatively

On the day before the surgery (day -1),an ultrasound will be performed in order to measure the velocity and the diameter of the portal vein, splenic vein, hepatic artery and hepatic veins and the flow will be calculated using the following mathematic formula: Flow= velocity x cross section area, as stated above. The following data will also be recorded: platelets, bilirubin (total and direct), albumin, cholesterol, urea, International Normalized Ratio, sodium, Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, Alkaline Phosphatase, gamma-Glutamyl Transferase and the Model for End-stage Liver Disease score of each patient will be calculated. Finally, our patients will undergo a Computer Tomography scan in order to measure their liver and spleen volumetry.

On the day of the surgery

On the day of the surgery (day 0), the following information will be recorded: the type of the surgical procedure, the duration (in minutes), the presence of ascites, the number of times and total duration of the a pringle maneuver and finally the percentage of the resection of the parenchyma will be calculated. A biopsy of healthy liver tissue will be sent for histological examination in order to determine the presence of fibrosis/cirrhosis and its stage.

Postoperatively

On the first, third and fifth postoperative day (day 1, 3, 5), the preoperative blood test and the ultrasound measurements will be repeated and the amount of fluid in the drain(s) and inside the abdomen (via ultrasound) will be recorded. Finally, the fluid will be sent for biochemical examination and culture.

On the seventh postoperative day (day 7) all blood, fluid and ultrasound measurements will be repeated and also the liver and spleen volumetry via CT.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

The Effect of Somatostatin in the Regulation of Velocity and Blood Flow of the Hepatic Circulation in Patients Undergoing Liver Resection

Anticipated Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Mar 31, 2020

Anticipated Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study group The study group includes participants who will receive somatostatin postoperatively (after liver resection).	Drug: Somatostatin 2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days
Placebo Comparator: Control group 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 24 hours infusion of 1000ml Normal Saline solution 0.9%

Arm

Intervention/Treatment

Active Comparator: Study group

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

Drug: Somatostatin

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

Placebo Comparator: Control group

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

24 hours infusion of 1000ml Normal Saline solution 0.9%

Outcome Measures

Primary Outcome Measures

The effect of somatostatin in the regulation of velocity of the hepatic circulation at patients who have undergone hepatectomy. [7 days]
The velocity of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically
The effect of somatostatin in the regulation of diameter of the vessels of the hepatic circulation at patients who have undergone hepatectomy. [7 days]
The diameter of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically
The effect of somatostatin in the regulation of blood flow of the hepatic circulation at patients who have undergone hepatectomy. [7 days]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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