CClinicalTrials.gg
Status unknownNCT00778362Updated Oct 23, 2008

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

An observational study in Overwhelming Post-Splenectomy Infection, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2008-10-23.

Sponsored by National Taiwan University Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2008), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
40
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overwhelming Post-Splenectomy Infection

Keywords

  • OPSI
  • Splenectomy
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

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

Exclusion Criteria:

  • who rejected interview.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
40 participants (estimated)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00778362
Lead sponsor
National Taiwan University Hospital
First posted
Oct 23, 2008
Start date
Jan 2006
Primary completion
Oct 2008 (estimated)
Completion
Dec 2012 (estimated)
Last update
Oct 23, 2008

Study contacts

Yu-Wen Tien, MD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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