4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection

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

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : July 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%

Outcome Measures
Primary Outcome Measures :
  1. The effect of somatostatin in the regulation of velocity of the hepatic circulation at patients who have undergone hepatectomy. [ Time Frame: 7 days ]
    The velocity of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically

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

  3. The effect of somatostatin in the regulation of blood flow of the hepatic circulation at patients who have undergone hepatectomy. [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria and those
  • Patients undergoing synchronous hepatectomy-colectomy.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Evgenia C Kotsifa, MD 00306986640874 eugeniakotsifa@yahoo.gr
Contact: Georgios C Sotiropoulos, MD, PhD 00306948111291 gsotirop@yahoo.com

Sponsors and Collaborators
Laikο General Hospital, Athens
Investigators
Layout table for investigator information
Study Chair: Georgios C Sotiropoulos, MD, PhD Assistant Professor of Surgery, Laiko Hospital
Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • The effect of somatostatin in the regulation of velocity of the hepatic circulation at patients who have undergone hepatectomy. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection
Official Title  ICMJE The Effect of Somatostatin in the Regulation of Velocity and Blood Flow of the Hepatic Circulation in Patients Undergoing Liver Resection
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Portal Hypertension
Intervention  ICMJE
  • Drug: Somatostatin
    2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days
  • Drug: Placebo
    24 hours infusion of 1000ml Normal Saline solution 0.9%
Study Arms  ICMJE
  • Active Comparator: Study group
    The study group includes participants who will receive somatostatin postoperatively (after liver resection).
    Intervention: Drug: Somatostatin
  • 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).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 4, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria and those
  • Patients undergoing synchronous hepatectomy-colectomy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Evgenia C Kotsifa, MD 00306986640874 eugeniakotsifa@yahoo.gr
Contact: Georgios C Sotiropoulos, MD, PhD 00306948111291 gsotirop@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010669
Other Study ID Numbers  ICMJE Somatostatin trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kotsifa Evgenia, Laikο General Hospital, Athens
Study Sponsor  ICMJE Laikο General Hospital, Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Georgios C Sotiropoulos, MD, PhD Assistant Professor of Surgery, Laiko Hospital
PRS Account Laikο General Hospital, Athens
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP