Splenectomy During Whole Liver Transplantation

NCT03609411 | Completed

• 1 other identifier: CRC_GHN_2018_002
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Liver Disease

Outcome Measures

Primary Outcomes (1)

• 3-month post-operative mortality

  At 3 months post surgery

Secondary Outcomes (3)

• Post-operative morbidity

  3 months post surgery

• One-year mortality

  One year after surgery

• Mortality at 5 years

  Five years after surgery

Study Arms (2)

Splenectomy

Patients undergoing liver transplantation with simultaneous splenectomy

Procedure: Splenectomy

Liver transplantation

Patients undergoing liver transplantation only

Interventions

Splenectomy PROCEDURE

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

Also known as: Liver transplantation

Splenectomy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing liver transplantation between 1994 and 2013

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital de la Croix-Rousse

Lyon, France

Location

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Splenectomy; Liver Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 1, 2018
• Study Start: January 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)