Splenectomy During Whole Liver Transplantation

Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.

Study Overview

• Status: Completed
• Conditions: End Stage Liver Disease
• Intervention / Treatment: Procedure: Splenectomy

Detailed Description

Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.

• Study Type: Observational
• Enrollment (Actual): 141

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hôpital de la Croix-Rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Among the 906 liver transplantations performed between 1994 and 2013 at the Liver Transplant Department of the Croix-Rousse University Hospital, Lyon-France, all 47 liver transplantations with simultaneous splenectomy were included and compared to 94 transplant recipients without splenectomy after a 1:2 matching for gender, age at transplantation, year of liver transplantation, MELD score, platelet level and presence of hepatocellular carcinoma.

Description

Inclusion Criteria:

• Patients undergoing liver transplantation between 1994 and 2013

Exclusion Criteria:

• Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Splenectomy; Patients undergoing liver transplantation with simultaneous splenectomy	Procedure: Splenectomy; Splenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels.; Other Names: Liver transplantation
Liver transplantation; Patients undergoing liver transplantation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-month post-operative mortality	At 3 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative morbidity	Incidence of portal-vein thrombosis within 3 months post liver transplantation	3 months post surgery
One-year mortality		One year after surgery
Mortality at 5 years		Five years after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: CRC_GHN_2018_002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No