SplenectomySPLEENVIVONCT06418256
Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations
An observational study of Splenectomy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Splenectomy
- What is being tested?
- Spleen, blood and plasma collection
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Oct 2016to 16 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with no age limit cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment.
Who may be able to join
- Adult patients
- Patient requiring left splenopancreectomy or planned splenectomy regardless of the method or indication
Who cannot join
- The patient notified his doctor of his refusal to recover his spleen and blood volume
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pierre Buffet, MD, PhD contact
5 sites in 1 country
France5 sites, 4 recruiting
- Recruiting
Hôpital Beaujon
Clichy, 92110
Alain Sauvanet, MD, PhD, 1 40 87 55 84 ext. + 33, alain.sauvanet@aphp.fr
Safi Dokmak, 1 40 87 57 97 ext. + 33, safi.dokmak@aphp.fr
- Recruiting
Hôpital Saint Antoine
Paris, 75012
François Paye, MD, PhD, 1 49 28 25 61 ext. + 33, françois.paye@aphp.fr
- Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Christophe Trésallet, MD, PhD, 1 42 17 66 03 ext. + 33, christophe.tresallet@aphp.fr
- Recruiting
Hôpital Necker-Enfants Malades
Paris, 75015
Pierre Buffet, MD, PhD, pierre.buffet@aphp.fr
- Active, not recruiting
Institut Pasteur
Paris, 75015
About this study
Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).
Read the detailed description
Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).
Participation to the study will be proposed to adult patients in whom a splenic intervention (spleno-pancreatectomy, or a total or partial splenectomy) is planned as part of their treatment.
One or more tubes of venous blood collected for the care will be retrieved following the pre- or intra-operative assessment. These samples will serve as controls during analyzes of splenic filtration mechanisms and/or perfusion experiments with populations of altered or modified cells and/or immunological and/or genetic analyses. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Samples from different experimental conditions (for example red blood cell containing malaria parasite for a culture) may be introduced in the perfusion system pour kinetic analyses. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses by cytology, cytometry, histology, immunohistochemistry, electronic microscopy, biochemistry, molecular biology, single cell analyses, on any other method. Peripheral and splenic blood samples or cells, as well as spleen fragments will be stored in. a biobank for further use or experimental analyses.
- Conditions
- Splenectomy
- Being tested
- Spleen, blood and plasma collection
- Keywords
- Spleen, Human splenic physiology, Splenic clearance, Splenic filtration mechanisms, Perfusion experiments, Role of the spleen in the adaptive immune response, Genetic spleen mechanisms, Blood, Erythrocytes, Leukocytes, Lymphocytes, Malaria, Sickle cell disease, Hereditary spherocytosis
- Medical subject headings
- Malaria, Anemia, Sickle Cell, Spherocytosis, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spleen, blood and plasma collectionOther
Adult patients for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their care. One or more tubes of venous blood collected for the care will be recovered following the pre- or intra-operative assessment. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult patients cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment. Receives: Other: Spleen, blood and plasma collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells
Ability of the isolated-perfused human spleen to filter altered cell populations.
Measured: Day 0
Secondary outcomes (5)
Exploring splenic immunological mechanisms
Explore splenic immunological mechanisms including the maintenance of long-term memory against Plasmodium sp antigens. and other infectious agents: Bartonella sp., Babesia sp., smallpox virus, measles, hepatitis.
Measured: Day 0
Kinetics of splenic clearance of altered or modified circulating elements
Explore the spleen filter role during infections, illnesses or use of blood cells, including properties of cells retained in the spleen, possibily after modification in vitro.
Measured: Day 0
Exploring splenic clearance mechanisms
Clearance mechanisms: tissue and cellular topography and concentration of deposition of normal or altered or modified cells in the spleen (Histology, Imaging, Electron Microscopy, etc.).
Measured: Day 0
Exploring the genetic control of spleen function
Genetic control of spleen function.
Measured: Day 0
Explore the impact of preservation processes on organ and cell functions, as well as engraftment
Testing optimized freezing methods with evaluation of cell function in vitro and engraftment in a mouse model.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start16 Oct 2016
- Primary completion16 Oct 2031 (estimated)
- Study completion16 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SplenectomyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Pierre Buffet, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418256
- Sponsor's protocol ID
- NI17003
- Other IDs
- 2024-A00654-43
- Acronym
- SPLEENVIVO
- Status last verified
- Sep 2025
- First submitted
- 13 May 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology and Pathologies Linked to Human Splenic Function : Direct and Ex-vivo Perfusion Explorations
- ClinicalTrials.gov ID
- NCT06418256
- Acronym / sponsor ID
- SPLEENVIVO / NI17003
- Conditions
- Splenectomy
- Keywords
- Spleen, Human splenic physiology, Splenic clearance, Splenic filtration mechanisms, Perfusion experiments, Role of the spleen in the adaptive immune response, Genetic spleen mechanisms, Blood
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Pasteur, URC-CIC Paris Descartes Necker Cochin
- Study start
- 16 Oct 2016 (actual)
- Primary completion
- 16 Oct 2031 (estimated)
- Study completion
- 16 Oct 2031 (estimated)
- First posted
- 17 May 2024 (actual)
- 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.
Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).
Detailed description
Human splenic physiology remains poorly understood due to lack of functional exploration. However, through its ability to recognize alterations or modifications in circulating cells and to trigger an innate and adaptive response in response to these anomalies, the spleen plays a central role in several diseases affecting blood cells, directly or indirectly. The analysis of the splenic clearance of abnormal cells during ex-vivo perfusions made it possible to clarify the pathogenesis of malaria and the role of the spleen in the adaptive immune response. The study's investigative team wishes to extend these explorations to other human diseases in which the spleen is involved, and to evaluate the preventive or curative potential of substances that can modify the perception of blood cells by the spleen (e.g. monoclonal antibodies directed against circulating cells, among other options).
Participation to the study will be proposed to adult patients in whom a splenic intervention (spleno-pancreatectomy, or a total or partial splenectomy) is planned as part of their treatment.
One or more tubes of venous blood collected for the care will be retrieved following the pre- or intra-operative assessment. These samples will serve as controls during analyzes of splenic filtration mechanisms and/or perfusion experiments with populations of altered or modified cells and/or immunological and/or genetic analyses. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Samples from different experimental conditions (for example red blood cell containing malaria parasite for a culture) may be introduced in the perfusion system pour kinetic analyses. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses by cytology, cytometry, histology, immunohistochemistry, electronic microscopy, biochemistry, molecular biology, single cell analyses, on any other method. Peripheral and splenic blood samples or cells, as well as spleen fragments will be stored in. a biobank for further use or experimental analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Spleen, blood and plasma collectionAdult patients cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with no age limit cared in one of the APHP hospital (Necker-Enfants Malades Hospital, Saint-Antoine Hospital, Pitié Salpêtrière Hospital and Beaujon Hospital) for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their treatment.
Key inclusion criteria (2 listed)
- Adult patients
- Patient requiring left splenopancreectomy or planned splenectomy regardless of the method or indication
Key exclusion criteria (1 listed)
- The patient notified his doctor of his refusal to recover his spleen and blood volume
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spleen, blood and plasma collectionAdult patients for whom a splenic intervention (spleno-pancreectomy, or a total or partial splenectomy) is planned as part of their care. One or more tubes of venous blood collected for the care will be recovered following the pre- or intra-operative assessment. Immediately following surgery, after careful examination by the pathologist in charge, the whole spleen or spleen fragments will be collected for further analysis. Whenever possible a catheter will be introduced in the splenic artery, the spleen will be flushed/rinsed with 0.1 - 2 L of cold perfusion medium then transferred to the laboratory for ex-vivo perfusion. Before and at the end of the ex-vivo perfusion, splenic blood and spleen fragments will be collected and processed for further analyses. | Other | Patients |
Primary outcome
Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells
Time frame: Day 0
Ability of the isolated-perfused human spleen to filter altered cell populations.
5 secondary outcomes
Exploring splenic immunological mechanisms
Time frame: Day 0
Kinetics of splenic clearance of altered or modified circulating elements
Time frame: Day 0
Exploring splenic clearance mechanisms
Time frame: Day 0
Exploring the genetic control of spleen function
Time frame: Day 0
Explore the impact of preservation processes on organ and cell functions, as well as engraftment
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Pierre Buffet, MD, PhD contact
Pierre Buffet, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splenectomy, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
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 2 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: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Buffet, MD, PhD (pierre.buffet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refine the understanding of spleen role during infections and conditions of the red blood cell and other human blood cells (time frame: Day 0). 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 15 Sep 2025.