- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05459883
Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome (splen ligation)
July 12, 2022 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital
Hemodynamic Modulations to Ameliorate Sinusoidal Injuries After Extended Liver Resections: the Role of Splenic Artery Ligation and Porto-caval Shunt in a Series of Patients
Our study aimed at assessing the changes of portal vein pressure, portal vein flow and hepatic arterial flow (HAF) in liver remnants ≤ 30% of the standard liver volume by reducing portal vein overflow via ligation of the splenic artery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
It has been reported that prevention of acute portal overpressure in small-for-size liver grafts leads to better postoperative outcomes.
Accordingly, we aimed to investigate the feasibility of the technique of splenic artery ligation in a case series of patients subjected to major liver resections with evidence of small-for-size syndrome and whether the maneuver results in reduction of portal venous pressure and flow.
Study Type
Observational
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Αττική
-
Athens, Αττική, Greece, 11528
- ARETAIEION University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
retrospective analysis of an internal hepatectomy database
Description
Inclusion Criteria:
- Adult patients
- American Society of Anesthesiologists (ASA) distribution I to III
- Patients scheduled for major liver resection (≥4 segments)
Exclusion Criteria:
- patients with extrahepatic disease
- patients with metastatic liver tumors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
portal vein pressure
Time Frame: through the operation, an average period of two hours
|
change of portal vein pressure from before liver resection to after reperfusion of the liver remnant
|
through the operation, an average period of two hours
|
|
portal vein flow
Time Frame: through the operation, an average period of two hours
|
change of portal vein flow from before liver resection to after reperfusion of the liver remnant
|
through the operation, an average period of two hours
|
|
hepatic artery flow
Time Frame: through the operation, an average period of two hours
|
change of hepatic artery flow from before liver resection to after reperfusion of the liver remnant
|
through the operation, an average period of two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Theodoraki K, Arkadopoulos N, Nastos C, Vassiliou I, Karmaniolou I, Smyrniotis V. Small liver remnants are more vulnerable to ischemia/reperfusion injury after extended hepatectomies: a case-control study. World J Surg. 2012 Dec;36(12):2895-900. doi: 10.1007/s00268-012-1779-6.
- Garcia-Valdecasas JC, Fuster J, Charco R, Bombuy E, Fondevila C, Ferrer J, Ayuso C, Taura P. Changes in portal vein flow after adult living-donor liver transplantation: does it influence postoperative liver function? Liver Transpl. 2003 Jun;9(6):564-9. doi: 10.1053/jlts.2003.50069.
- Kinaci E, Kayaalp C. Portosystemic Shunts for "Too Small-for-Size Syndrome" After Liver Transplantation: A Systematic Review. World J Surg. 2016 Aug;40(8):1932-40. doi: 10.1007/s00268-016-3518-x.
- Lo CM, Liu CL, Fan ST. Portal hyperperfusion injury as the cause of primary nonfunction in a small-for-size liver graft-successful treatment with splenic artery ligation. Liver Transpl. 2003 Jun;9(6):626-8. doi: 10.1053/jlts.2003.50081.
- Umeda Y, Yagi T, Sadamori H, Matsukawa H, Matsuda H, Shinoura S, Mizuno K, Yoshida R, Iwamoto T, Satoh D, Tanaka N. Effects of prophylactic splenic artery modulation on portal overperfusion and liver regeneration in small-for-size graft. Transplantation. 2008 Sep 15;86(5):673-80. doi: 10.1097/TP.0b013e318181e02d.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
December 31, 2021
Study Completion (ACTUAL)
December 31, 2021
Study Registration Dates
First Submitted
July 10, 2022
First Submitted That Met QC Criteria
July 12, 2022
First Posted (ACTUAL)
July 15, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 15, 2022
Last Update Submitted That Met QC Criteria
July 12, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 418/18-04-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemia
-
University Hospital, Strasbourg, FranceTerminatedVascular Surgery | Ischemia-reperfusion | Ischemia PreconditioningFrance
-
Beytepe Murat Erdi Eker State HospitalCompletedAnterior Segment Ischemia (Diagnosis)
-
University Hospital, Strasbourg, FranceCompletedSkeletal Muscle Ischemia | Severe Lower Limb Ischemia | Mitochondrial DysfunctionFrance
-
Egyptian Cerebro-Cardio-Vascular AssociationUnknownRisk Factor, Cardiovascular | Ischemia, Myocardial | Ischemia, Cerebral
-
Technische Universität DresdenRecruitingRetinal IschemiaGermany
-
Centre Hospitalier Universitaire de NiceCompleted
-
Attikon HospitalUniversity Hospital of PatrasCompleted
-
Beth Israel Deaconess Medical CenterWithdrawn
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Hospices Civils de LyonCompleted
Clinical Trials on splenic artery ligation
-
Institute of Liver and Biliary Sciences, IndiaCompletedCirrhosis, LiverIndia
-
Assiut UniversityNot yet recruitingLiving Donor Liver Transplantation
-
University of Alabama at BirminghamCompleted
-
Russian Society of Colorectal SurgeonsUnknown
-
Azienda Socio Sanitaria Territoriale degli Spedali...Completed
-
Sichuan Cancer Hospital and Research InstituteSichuan Provincial People's Hospital; The Second People's Hospital of ChengduNot yet recruiting
-
Oslo University HospitalUnknownWounds and InjuriesDenmark, United States, Australia, Canada, Germany, Netherlands, Norway, Sweden, United Kingdom
-
West China HospitalUnknownLung Cancer | Surgery | Circulating Tumor CellChina
-
Zagazig UniversityActive, not recruitingGrade III Traumatic Splenic Injury in Hemodynamically Stable PatientsEgypt
-
Minia Maternity University HospitalCompletedPlacenta Previa Without HemorrhageEgypt