Clinical trial NCT04199403: Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
Official title: Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asplenia
Keywords: spleen
asplenic patients
splenectomy
asplenia
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Pr Pierre BUFFET Institut National de la Transfusion Sanguine
name: Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier
First posted: 2019-12-13
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years with acquired asplenia due to splenectomy, artery embolization, or spleen radiotherapy

Brief summary: Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.

Detailed description: Asplenia can be congenital or acquired. Acquired asplenia can be due to diagnostic or therapeutic surgery, splenic artery embolization, or radiotherapy. Incidence of splenectomized patients was estimated between 10 and 15/100 000 persons in 2003. More recent data suggested a decrease in splenectomy due to increase of splenic artery embolization. From 212 to 2016, about 4000 splenectomy had still been performed.

Three different risks are known for asplenic patients: infectious, neoplastic, and thromboembolic. Prevalence rate of infectious complications in splenectomized patients was 3.2% with a mortality rate of 1.4%. A US cohort study including 8149 splenectomized veterans have shown that the risk of cancer was increased, so did the risk of thromboembolic disease, on a 27-year period of follow-up. Pathophysiology of these risks are not well known.

There are very few tools to assess splenic function: Howell-Jolly bodies in red blood cells, scintigraphy. These tools lack sensitivity and are not correlated with complications in asplenic patients.

To better understand how splenic function and how immunity evolves during time in asplenic patients, a longitudinal follow-up could be useful. There may be some differences between splenectomized patients, those who benefited from splenic artery embolization, and those who received radiotherapy. Infectious risk may be different between these three groups. Implementing new tools assessing residual splenic function could improve management of these patients. A prospective follow-up aims at accurately estimate the incidence rate of infectious and non-infectious complications in this population.

Eligibility criteria: Inclusion Criteria:

* ≥18 year-old
* With asplenia due to splenectomy, splenic artery embolization or radiotherapy

Exclusion Criteria:

* Genetic asplenia including sick cell disease

Primary outcomes:
measure: Assessment of complication risk factors
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angoulême
country: France
facility: C.H. d'Angoulême
city: Argenteuil
country: France
facility: C.H. Victor Dupouy
city: Béthune
country: France
facility: C.H. de Béthune
city: Chartres
country: France
facility: Hôpitaux de Chartres
city: Lille
country: France
facility: C.H.U. de Lille
city: Montpellier
country: France
facility: C.H.U. de Montpellier
city: Nantes
country: France
facility: Hôtel-Dieu - CHU de Nantes
city: Poitiers
country: France
facility: C.H.U. de Poitiers
city: Rouen
country: France
facility: C.H.U. de Rouen
city: Toulouse
country: France
facility: C.H.U. de Toulouse
city: Tourcoing
country: France
facility: C.H. de Tourcoing
city: Valenciennes
country: France
facility: C.H. de Valenciennes
Study officials:
affiliation: C.H.U. de Poitiers
name: Mathieu PUYADE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014 Feb;99(2):392-8. doi: 10.3324/haematol.2013.092460. Epub 2013 Sep 20.
citation: Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.
citation: Aiolfi A, Inaba K, Strumwasser A, Matsushima K, Grabo D, Benjamin E, Lam L, Demetriades D. Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes. J Trauma Acute Care Surg. 2017 Sep;83(3):356-360. doi: 10.1097/TA.0000000000001550.