NCT05459883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

5 years

First QC Date

July 10, 2022

Last Update Submit

July 12, 2022

Conditions

Keywords

small-for-size liver syndromeligationsplenic arteryhepatectomyliver regeneration

Outcome Measures

Primary Outcomes (3)

  • portal vein pressure

    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

    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

    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

Interventions

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective analysis of an internal hepatectomy database

You may qualify if:

  • Adult patients
  • American Society of Anesthesiologists (ASA) distribution I to III
  • Patients scheduled for major liver resection (≥4 segments)

You may not qualify if:

  • patients with extrahepatic disease
  • patients with metastatic liver tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieion University Hospital

Athens, Attica, 11528, Greece

Location

Related Publications (5)

  • 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.

    PMID: 22956015BACKGROUND
  • 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.

    PMID: 12783396BACKGROUND
  • 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.

    PMID: 27160453BACKGROUND
  • 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.

    PMID: 12783407BACKGROUND
  • 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.

    PMID: 18791439BACKGROUND

MeSH Terms

Conditions

IschemiaReperfusion Injury

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesPostoperative Complications

Study Officials

  • Kassiani Theodoraki

    Aretaieion University Hospital, Athens, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

July 10, 2022

First Posted

July 15, 2022

Study Start

January 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations