RECRUITINGINTERVENTIONAL

Effect of Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in Patients With Intracranial Lymphatic Circulation Disorder

Effect of Cervical Lymphaticovenous Anastomosis and Cervical Lymph Node to Vein Anastomosis for the Patient With Intracranial Lymphatic Circulation Disorder

About This Trial

This study is a single-center, prospective clinical trial designed to evaluate the therapeutic effects of lymphaticovenular anastomosis (LVA) and lymph node-venous anastomosis (LNVA) in patients with intracranial lymphatic circulation disorders. Following voluntary written informed consent, screening assessments will be performed in accordance with the clinical trial protocol. Eligibility will be determined based on the predefined inclusion and exclusion criteria, and eligible subjects will be enrolled in the study. Enrolled participants will undergo cognitive function assessments at baseline (pre-surgery) and at 1, 3, 6, 9, 12, 18, and 24 months postoperatively for follow-up. Cognitive evaluations will not be additionally performed for research purposes but will be conducted in accordance with the existing clinical care schedule and standard treatment guidelines.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation. - Global Deterioration Scale (GDS) score between 3 and 5 at screening. - Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder. - Able to provide written willing to sign a consent form to participate in the study voluntarily. Who Should NOT Join This Trial: - Unable to undergo follow-up evaluation for at least 12 months after surgery. - Diagnosed with vascular dementia. - Presence of structural brain disease other than intracranial lymphatic circulation disorder. - Known hypersensitivity to indocyanine green (ICG). - Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders. - History of previous neck surgery. - Refusal to participate or failure to provide willing to sign a consent form. - Determined by the principal investigator to be unsuitable for participation due to any other clinical reason. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 19 years or older who are diagnosed with intracranial lymphatic circulation disorder based on neurological evaluation. * Global Deterioration Scale (GDS) score between 3 and 5 at screening. * Diagnosis of Alzheimer's disease confirmed by amyloid PET-CT or CSF amyloid testing, showing amyloid accumulation associated with lymphatic circulation disorder. * Able to provide written informed consent to participate in the study voluntarily. Exclusion Criteria: * Unable to undergo follow-up evaluation for at least 12 months after surgery. * Diagnosed with vascular dementia. * Presence of structural brain disease other than intracranial lymphatic circulation disorder. * Known hypersensitivity to indocyanine green (ICG). * Uncontrolled systemic medical conditions such as severe cardiopulmonary, renal, hepatic, or endocrine disorders. * History of previous neck surgery. * Refusal to participate or failure to provide informed consent. * Determined by the principal investigator to be unsuitable for participation due to any other clinical reason.

Treatments Being Tested

PROCEDURE

Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis

This microsurgical procedure involves connecting the cervical lymphatic vessels and lymph nodes to adjacent veins to enhance lymphatic drainage from the brain. The purpose of the surgery is to reduce amyloid accumulation and improve cognitive function in patients with intracranial lymphatic circulation disorders. Before the operation, ultrasound imaging is used to identify the lymphatic vessels, lymph nodes, and nearby veins. A small incision of approximately 2-3 cm is made along the sternocleidomastoid muscle. Indocyanine green (ICG) dye is injected to visualize lymphatic flow, and under microscopic guidance, the lymphatic structures are anastomosed to the adjacent veins. Finally, the incision is closed with adhesive, and no postoperative drainage is required.

Locations (1)

Asan Medical Center

Seoul, South Korea