Thymectomy Clinical Trials

Clinical trials related to Thymectomy Procedure

Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections. The THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery. This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants: * One group undergoing heart surgery with complete thymectomy; * One group undergoing heart surgery with partial thymectomy; * One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery. By comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery. Participation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• \- Children aged between 0 and 6 months;

• Born at a gestational age \> 37 weeks' gestation;

• With an indication for cardiac surgery under CEC at Nantes University Hospital;

• Cardiopediatric follow-up planned at Nantes University Hospital;

• Written agreement signed by legal guardians to participate in the study.

∙ For the control groups:

• Control group A (cardiac surgery without thymectomy):

‣ Children aged between 0 and 6 months of age;

⁃ Born at a gestational age \> 37 SA;

⁃ Indicated for thoracotomy cardiac surgery at Nantes University Hospital;

⁃ Cardiopediatric follow-up planned at Nantes University Hospital;

⁃ Written agreement signed by legal guardians to participate in the study.

• Control group B (non-cardiac surgery)

‣ Children aged between 0 and 6 months;

⁃ Born at a gestational age \> 37 SA;

⁃ Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);

⁃ Planned follow-up surgery at Nantes University Hospital;

⁃ Written agreement signed by legal guardians to participate in the study.

Locations
Other Locations
France
Chu de Nantes
RECRUITING
Nantes
CHU de Nantes
NOT_YET_RECRUITING
Nantes
Contact Information
Primary
Alexis Chenouard, PH
alexis.chenouard@chu-nantes.fr
02 44 76 82 21
Backup
Evelyne Gauvard
Evelyne.GAUVARD@chu-nantes.fr
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 70
Treatments
Experimental: Complete Thymectomy Group
Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB), during which a complete thymectomy is performed for surgical access to the heart and great vessels. The extent of thymus resection is determined by the cardiac surgeon intraoperatively, based on anatomical considerations
Experimental: Partial Thymectomy Group
Infants undergoing cardiac surgery with CPB, during which a partial thymectomy is performed, with an effort to preserve thymic tissue when anatomically feasible.
Active_comparator: Control Group (No Thymectomy
Infants undergoing:~* Cardiac surgery by thoracotomy without thymectomy (e.g., for aortic coarctation) or~* Non-cardiac surgery (e.g., digestive procedures) with complete preservation of the thymus.~These patients serve as immunological reference controls
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov