RESTORE trial version 1
Research type
Research Study
Full title
Autogenic splenic implantation in distal pancreatectomy with splenectomy for benign lesions of the distal pancreas
IRAS ID
248540
Contact name
Mohammed Abu Hilal
Contact email
Sponsor organisation
R&D Department University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Patients with benign lesions of the left part of the pancreas often need resection of the left part of the pancreas, this operation is called a distal pancreatectomy (DP). DP often involves removal of the spleen because the blood supply of the spleen is close or adherent to the pancreas. Patients without a spleen have an increased risk of developing possibly lethal infectious complications, thrombosis, as well as certain cancers. Because of the risk of infectious complications, patients are required regular vaccinations and a lifelong course of prophylactic antibiotics. Because of these risks spleen preserving DP is now the preferred approach. However, splenic preservation is not always technically feasible and many patients end up with their spleen resected (splenectomy). With this research we will reimplant pieces of the resected spleen (autogenic splenic implantation), at the same operation. This has been successfully done in the past multiple times, but there is no evidence yet if the reimplanted pieces of spleen are functional like a normal spleen. Six months after reimplantation, we will test the functionality by vaccinating the participants with a Salmonella vaccine and test the immunological response of the body to this vaccine by measuring antibodies in the blood. Antibodies are produced by the immune system and help clear the body from infections. We will compare the antibody response of participants who underwent autogenic splenic implantation with two control groups: participants who underwent spleen preserving DP and participants who underwent DP with splenectomy. If the antibody response is adequate, patients not longer require regular vaccinations and lifelong prophylactic antibiotics in the future.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0364
Date of REC Opinion
15 Aug 2018
REC opinion
Further Information Favourable Opinion