Overwhelming Post-Splenectomy InfectionNCT00778362
Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein
An observational study of Overwhelming Post-Splenectomy Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Overwhelming Post-Splenectomy Infection
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years.
Who cannot join
- who rejected interview.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overwhelming Post-Splenectomy Infection
- Keywords
- OPSI, Splenectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Splenectomy | all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: every one year after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJan 2006
- Primary completionOct 2008 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overwhelming Post-Splenectomy InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Wen Tien, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778362
- Sponsor's protocol ID
- 200805057R
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splenic Function After Spleen-Preserving Distal Pancreatectomy With Excision of Splenic Artery and Vein
- ClinicalTrials.gov ID
- NCT00778362
- Acronym / sponsor ID
- 200805057R
- Conditions
- Overwhelming Post-Splenectomy Infection
- Keywords
- OPSI, Splenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Splenectomy | – | –all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients received splenectomy (patient list will be applied from Dept. of Pathology) at National Taiwan University Hospital in the last 20 years.
Key exclusion criteria (1 listed)
- who rejected interview.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2008.
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Infection;Post Surg Procedure, Peritoneal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Wen Tien, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overwhelming Post-Splenectomy Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2008.