Clinical trial NCT05459883: Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small-For-Size Liver Syndrome
Ligation
Liver Regeneration
Splenic Artery
Portal Vein
Ischemia
Reperfusion Injury
Hepatectomy
Keywords: small-for-size liver syndrome
ligation
splenic artery
hepatectomy
liver regeneration
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: retrospective analysis of an internal hepatectomy database

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: portal vein pressure
timeFrame: through the operation, an average period of two hours
measure: portal vein flow
timeFrame: through the operation, an average period of two hours
measure: hepatic artery flow
timeFrame: through the operation, an average period of two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
state: Αττική
Study officials:
affiliation: Aretaieion University Hospital, Athens, Greece
name: Kassiani Theodoraki
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.