Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

Recruiting

• Conditions: Asplenia

• Registration Number: NCT04199403
• Lead Sponsor: Poitiers University Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Study Start: 2020-01-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2040-01
• Study Completion: 2040-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

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

Exclusion Criteria

• Genetic asplenia including sick cell disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of complication risk factors	3 years	Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease

Trial Locations

Locations (12)

C.H. d'Angoulême; 🇫🇷 Angoulême, France

C.H. Victor Dupouy; 🇫🇷 Argenteuil, France

C.H. de Béthune; 🇫🇷 Béthune, France

Hôpitaux de Chartres; 🇫🇷 Chartres, France

C.H.U. de Lille; 🇫🇷 Lille, France

C.H.U. de Montpellier; 🇫🇷 Montpellier, France

Hôtel-Dieu - CHU de Nantes; 🇫🇷 Nantes, France

C.H. de Tourcoing; 🇫🇷 Tourcoing, France

C.H. de Valenciennes; 🇫🇷 Valenciennes, France

C.H.U. de Toulouse; 🇫🇷 Toulouse, France

C.H.U. de Poitiers; 🇫🇷 Poitiers, France

C.H.U. de Rouen; 🇫🇷 Rouen, France