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NCT03609411 Clinical Trial

Splenectomy During Whole Liver Transplantation

End Stage Liver Disease Clinical Trial

Official title:
Splenectomy During Whole Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03609411
Other study ID # CRC_GHN_2018_002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date January 2017

Study information
Verified date July 2018
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 141
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Splenectomy
Splenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels.

Locations
Country Name City State
France Hopital de la Croix-Rousse Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 3-month post-operative mortality At 3 months post surgery
Secondary Post-operative morbidity Incidence of portal-vein thrombosis within 3 months post liver transplantation 3 months post surgery
Secondary One-year mortality One year after surgery
Secondary Mortality at 5 years Five years after surgery
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