Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00778362
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition
Overwhelming Post-Splenectomy Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: twenty year after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: every one year after the operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Splenectomy
all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00778362

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yu-Wen Tien, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yu-Wen Tien/Association Proferssor , Department of Surgery, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00778362     History of Changes
Other Study ID Numbers: 200805057R
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
OPSI
Splenectomy

ClinicalTrials.gov processed this record on July 22, 2014