Small-For-Size Liver Syndromesplen ligationNCT05459883
Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome
An observational study of Small-For-Size Liver Syndrome and Ligation, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small-For-Size Liver Syndrome, Ligation, Liver Regeneration
- What is being tested?
- splenic artery ligation
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2017to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: retrospective analysis of an internal hepatectomy database
Who may be able to join
- Adult patients
- American Society of Anesthesiologists (ASA) distribution I to III
- Patients scheduled for major liver resection (≥4 segments)
Who cannot join
- patients with extrahepatic disease
- patients with metastatic liver tumors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Small-For-Size Liver Syndrome, Ligation, Liver Regeneration, Splenic Artery, Portal Vein, Ischemia
- Being tested
- splenic artery ligation
- Keywords
- small-for-size liver syndrome, ligation, splenic artery, hepatectomy, liver regeneration
- Medical subject headings
- Ischemia, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splenic artery ligationProcedure or surgery
We identified portal hyperperfusion as a cause of potential small-for-size liver remnant dysfunction and we applied splenic artery ligation as a technically simple procedure to manage the situation
What is being measured
The primary outcome is the main question the study is designed to answer.
portal vein pressure
change of portal vein pressure from before liver resection to after reperfusion of the liver remnant
Measured: through the operation, an average period of two hours
portal vein flow
change of portal vein flow from before liver resection to after reperfusion of the liver remnant
Measured: through the operation, an average period of two hours
hepatic artery flow
change of hepatic artery flow from before liver resection to after reperfusion of the liver remnant
Measured: through the operation, an average period of two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Small-For-Size Liver SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, Principal investigator, Aretaieion University Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459883
- Sponsor's protocol ID
- 418/18-04-2022
- Acronym
- splen ligation
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22956015Garcia-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.
PubMed 12783396Kinaci 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.
PubMed 27160453Lo 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.
PubMed 12783407Umeda 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.
PubMed 18791439
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05459883
- Acronym / sponsor ID
- splen ligation / 418/18-04-2022
- Conditions
- Small-For-Size Liver Syndrome, Ligation, Liver Regeneration, Splenic Artery, Portal Vein, Ischemia
- Keywords
- small-for-size liver syndrome, ligation, splenic artery, hepatectomy, liver regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- retrospective analysis of an internal hepatectomy database
Key inclusion criteria (3 listed)
- Adult patients
- American Society of Anesthesiologists (ASA) distribution I to III
- Patients scheduled for major liver resection (≥4 segments)
Key exclusion criteria (2 listed)
- patients with extrahepatic disease
- patients with metastatic liver tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| splenic artery ligationWe identified portal hyperperfusion as a cause of potential small-for-size liver remnant dysfunction and we applied splenic artery ligation as a technically simple procedure to manage the situation | Procedure or surgery | – |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Background: PubMed 22956015Theodoraki 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.
- Background: PubMed 12783396Garcia-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.
- Background: PubMed 27160453Kinaci 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.
- Background: PubMed 12783407Lo 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.
- Background: PubMed 18791439Umeda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassiani Theodoraki principal investigator
Aretaieion University Hospital, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small-For-Size Liver Syndrome and Ligation, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
portal vein pressure (time frame: through the operation, an average period of two hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459883, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.