Feasibility and short-term perioperative safety of composite deep cervical lymphatic reconstruction and vagus nerve microneurolysis in Parkinson's disease: a first-in-indication pilot case series.

Background: Parkinson's disease (PD) remains associated with motor, non-motor, quality-of-life, and caregiver-burden needs despite pharmacological therapy. Anatomical and translational studies have drawn attention to cervical lymphatic pathways and vagal biology in PD, but surgical manipulation of these structures has not been clinically evaluated. Objective: To evaluate the technical feasibility and short-term perioperative safety of a composite cervical microsurgical procedure combining deep cervical lymphatic-venous reconstruction and cervical vagus nerve microneurolysis in selected patients with PD. Methods: In this prospective, single-center, single-arm, first-in-indication pilot case series, nine clinically diagnosed participants underwent the composite procedure. The main study focus was procedural completion and short-term safety monitoring. M3 was prespecified for exploratory medication-OFF scale collection. Outcome assessors were not blinded. Results: All nine participants completed the procedure and M3 assessment. Lymphatic reconstruction was completed in every case, with 10-12 anastomoses per participant, and intraoperative near-infrared indocyanine green imaging confirmed lymphatic-to-venous filling at completion. No surgery-related serious adverse events, reoperations, or complications requiring invasive intervention were recorded through available follow-up. Follow-up retention through M3 was 100%; lower denominators at later timepoints reflected staggered enrollment and follow-up maturity, not withdrawal or loss to follow-up. At M3, exploratory clinical scale changes were in the direction of score reduction. These descriptive observations are compatible with non-specific effects, including expectancy, natural fluctuation, medication influences, and observer bias, and cannot be attributed to the procedure without a control group, blinded assessment, standardized medication trajectories, or mechanistic readouts. Conclusion: The composite procedure was technically feasible, with no short-term surgery-related serious safety signal observed in this selected cohort. Exploratory clinical scale changes do not establish efficacy, durability, disease modification, target engagement, or component-specific effects. Controlled studies with blinded assessment and direct mechanistic endpoints are required.