Effect of Cervical Lymphaticovenous and Lymph Node-to-Vein Anastomosis in Patients With Intracranial Lymphatic Circulation Disorder
NCT ID: NCT07328386
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2025-02-20
2026-12-31
Brief Summary
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Detailed Description
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Because waste clearance from the brain occurs through lymphatic pathways, dysfunction of lymphatic circulation has been identified as an important contributing factor to MCI and dementia. However, due to the minute diameter of lymphatic vessels-typically less than 1 mm-direct therapeutic interventions targeting lymphatic function have long remained unexplored.
Recent advances in supermicrosurgical techniques have enabled procedures on lymphatic vessels as small as 0.2-0.3 mm, leading to the development of novel treatments for lymphatic circulation disorders. For example, patients with upper or lower extremity lymphedema, a representative condition of lymphatic dysfunction, have shown significant improvement following lymphaticovenular anastomosis (LVA) or lymph node-venous anastomosis (LNVA).
Lymphedema results from obstruction or damage to lymphatic pathways, causing the accumulation of lymphatic fluid in tissues. LVA and LNVA are microsurgical procedures that create new bypass routes by connecting lymphatic vessels or lymph nodes directly to adjacent veins, thereby allowing lymphatic fluid to drain into the venous system and re-enter systemic circulation. These procedures have been performed for more than two decades, with excellent therapeutic outcomes reported over the past five years. At Asan Medical Center, more than 100 such procedures are successfully performed annually.
Furthermore, based on the same principle applied in limb lymphedema, recent case-level studies have suggested that performing LVA or LNVA in lymphatic pathways or lymph nodes responsible for cerebral waste clearance may improve degenerative neurological conditions, including Alzheimer's disease. Based on this accumulated knowledge and surgical expertise, cervical lymphaticovenular anastomosis and cervical lymph node-venous anastomosis will be performed to connect lymphatic vessels and lymph nodes involved in cerebral lymphatic drainage to adjacent veins.
It is hypothesized that this procedure may help slow disease progression, preserve quality of life, and potentially improve cognitive function in patients with mild cognitive impairment or dementia.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
1. a surgical intervention group receiving cervical lymphaticovenous and lymph node-to-vein anastomosis plus standard medical therapy, and
2. a control group receiving standard medical therapy alone. The two groups will be followed over the same time points to compare changes in cognitive and clinical outcomes.
TREATMENT
NONE
Study Groups
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Surgical Intervention Group
Participants in this group will undergo cervical lymphaticovenous anastomosis (LVA) and cervical lymph node-to-vein anastomosis (LNVA).
The procedure connects cervical lymphatic vessels and lymph nodes to adjacent veins to facilitate lymphatic drainage from the brain and reduce amyloid accumulation associated with intracranial lymphatic circulation disorder in patients with Alzheimer's disease.
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.
Control Group
Participants in this group will receive standard medication therapy only, following the hospital's routine treatment guidelines for Alzheimer's disease.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
100 Years
ALL
No
Sponsors
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Hong Joonpio
OTHER
Responsible Party
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Hong Joonpio
Principal Investigator
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-0033
Identifier Type: -
Identifier Source: org_study_id
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