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

• Sponsor: Aretaieion University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05459883
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small-For-Size Liver Syndrome; Ligation; Liver Regeneration; Splenic Artery; Portal Vein; Ischemia; Reperfusion Injury; Hepatectomy	Procedure: splenic artery ligation

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

• Study Type: Observational
• Actual Enrollment: 13 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. portal vein pressure [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aretaieion University Hospital	Athens	Αττική	Greece	11528

Sponsors and Collaborators

• Aretaieion University Hospital

Investigators

• Principal Investigator: Kassiani Theodoraki, Aretaieion University Hospital, Athens, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital
• ClinicalTrials.gov Identifier: NCT05459883
• Other Study ID Numbers: 418/18-04-2022
• First Posted: Jul 15, 2022
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr Kassiani Theodoraki, Professor of Anesthesiology, Aretaieion University Hospital: small-for-size liver syndrome; ligation; splenic artery; hepatectomy; liver regeneration
• Additional relevant MeSH terms: Reperfusion Injury; Syndrome; Ischemia

Study Results

No Results Posted as of Jul 15, 2022