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Completed

NCT Number: NCT05459883

Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome

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.

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Key information

Conditions

Small-For-Size Liver Syndrome Cardiovascular Diseases Hepatectomy Ischemia Ligation Liver Regeneration Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Vein Postoperative Complications Reperfusion Injury Splenic Artery Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aretaieion University Hospital

Athens, Attica, 11528, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Splenic artery ligation

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study 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

Acronym: splen ligation

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2022
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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