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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05459883
Other study ID # 418/18-04-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2021

Study information

Verified date July 2022
Source Aretaieion University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Intervention

Procedure:
splenic artery ligation
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

Locations

Country Name City State
Greece Aretaieion University Hospital Athens ?tt???

Sponsors (1)

Lead Sponsor Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

García-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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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