Autologous great saphenous vein interposition for haemodialysis access in patients with inadequate upper-extremity veins: a two-centre pilot randomised controlled trial

<title>Abstract</title> <p>Background Many patients with end-stage renal disease (ESRD) lack suitable forearm veins for standard native arteriovenous fistula (AVF). Prosthetic grafts are associated with an elevated risk of infection and thrombosis. Autologous great saphenous vein (GSV) interposition represents an alternative access technique, yet high-quality randomised evidence remains limited. Methods This two-centre pilot randomised controlled trial recruited a total of 40 ESRD patients from two tertiary hospitals (Yingtan 184 Hospital of China RongTong Medical Healthcare Group Co. Ltd. and the Second Affiliated Hospital of Jiangxi Medical College, Nanchang University) and allocated participants 1:1 to GSV interposition (n = 20) or conventional upper-limb native/ePTFE AV access (control). Primary outcome: 24-month primary AV patency. Secondary outcomes included intraoperative metrics, serial patency, complications and one-month Doppler haemodynamic parameters. Statistical analysis employed the Kaplan–Meier method with the log-rank test and multivariate logistic regression. Results The GSV group showed a numerically higher rate of 24-month primary patency (70% vs 50%, log-rank P = 0.082). Intraoperative blood loss was significantly lower, though operation time was prolonged (both P &lt; 0.001). All postoperative haemodynamic indices were significantly superior in the GSV cohort. Overall complication rates were numerically lower (10.0% vs 35.0%, P = 0.127). GSV interposition was an independent protective factor against access failure (OR = 0.235, 95%CI 0.068–0.812, P = 0.022). Conclusions GSV interposition yields favourable haemodynamics and a non-significant trend towards improved long-term patency for patients unsuitable for routine upper-limb AVF, based on data from two tertiary medical centres. Large, prospectively registered multicentre randomised trials are required to validate these exploratory pilot findings. Trial registration: Chinese Clinical Trial Registry ChiCTR2500112130, registered on 2025-11-10 (retrospectively registered after participant recruitment).</p>