Condition or disease | Intervention/treatment | Phase |
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Portal Hypertension | Drug: Somatostatin Drug: Placebo | Phase 3 |
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 : | 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 |
Arm | Intervention/treatment |
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Active Comparator: Study group
The study group includes participants who will receive somatostatin postoperatively (after liver resection).
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Drug: Somatostatin
2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days
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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).
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Drug: Placebo
24 hours infusion of 1000ml Normal Saline solution 0.9%
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Evgenia C Kotsifa, MD | 00306986640874 | eugeniakotsifa@yahoo.gr | |
Contact: Georgios C Sotiropoulos, MD, PhD | 00306948111291 | gsotirop@yahoo.com |
Study Chair: | Georgios C Sotiropoulos, MD, PhD | Assistant Professor of Surgery, Laiko Hospital |
Tracking Information | |||||||||
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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 |
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention |
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Condition ICMJE | Portal Hypertension | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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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 |
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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 |