Overwhelming Post-Splenectomy Infection Clinical Trial
Official title:
Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein
| Verified date | October 2008 |
| Source | National Taiwan University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Taiwan: Department of Health |
| Study type | Observational |
The spleen may be removed due to benign hematologic disorders, such as idiopathic
thrombocytopenic purpura and hereditary spherocytosis, or malignancies, such as lymphomas
and leukemias. Splenectomy may also be performed due to splenic traumas or in association of
some surgical procedures, when combined splenectomy will make the operations easier. The
most well known procedure is distal pancreatectomy combined with splenectomy.
In this research, there are two main goals. Firstly, establish the data about the incidence
of overwhelming postsplenectomy infection (OPSI) in our country. Currently, the western data
of the incidence, morbidity rate and mortality rate of OPSI is well established and
vaccination along with prophylactic antibiotics is strongly recommended. Since the incidence
of OPSI in our country isn't clear, most (>95%) splenectomized patients in our hospital
(National Taiwan University Hospital) did not have vaccination or prophylactic antibiotics.
We'll try to determine the incidence of OPSI by reviewing of our hospital charts and by
structured interviews with patients.
The spleen is a phagocytic filter. So asplenic patients have higher risks of getting
infection and some spleen-preserving procedures are proposed. In our initial experiences,
distal pancreatectomy with splenic artery and vein divided could be safely performed and
greatly increased the possibility of preservation of spleen. However, when the spleen was
preserved with dividing the splenic artery and vein, the blood supply to the spleen will be
shifted from splenic artery to short gastric artery. Although a substantial immunologic
advantage exists if splenic tissue remains, this may not offer sufficient protection from
encapsulated bacteria if splenic arterial blood flow is reduced because experimental animal
studies have demonstrated that an intact splenic arterial system is necessary for optimal
control of infection. Thus, although the spleen is preserved in above mentioned procedure,
the function of the preserved spleen is questionable and has never been studied of. Our
second object is to determine the splenic function after after spleen-preserving distal
pancreatectomy with excision of splenic artery and vein by comparison of abdominal computed
tomography and immunological function of patients before and after operation. Besides, we'll
designed an animal experiment to examine the rate of pneumococcal clearance by the spleen
and to determine the relationship between splenic blood flow and splenic tissue mass in
bacterial clearance from the blood when the splenic vessels were divided.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | December 2012 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years. Exclusion Criteria: - who rejected interview. |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | A questionnaire will be administered to assess 1. the degree of knowledge and patient compliance and their role in the prevention of OPSI; 2. history of vaccination and prophylactic antibiotics to prevent OPSI; 3. infection episodes after splenectomy. | twenty year after operation | Yes | |
| Secondary | to determine the benefits (preserved immunologic function) and risk (gastric varices and even bleeding) of preservation of spleen after distal pancreatectomy without conservation of splenic artery | every one year after the operation | Yes |