Comparison of two different seeds strand fabrication and implantation methods combined with metallic stent in the treatment of malignant obstructive jaundice

Background Malignant obstructive jaundice presents a challenging clinical scenario where biliary stenting serves as a pivotal palliative intervention to restore biliary drainage. While the combination of a biliary stent with an ¹²⁵ I seeds strand has emerged as a mainstream strategy to prolong stent patency and enhance patient survival, the conventional approach is significantly hampered by its propensity to cause substantial bile duct injury and a high associated rate of complications. In response to these limitations, this study introduced and evaluated a refined methodology. We developed an improved technique for fabricating the ¹²⁵ I seeds strand and implemented a novel, less invasive implantation protocol. The primary objective of this investigation was to systematically compare this optimized approach against conventional methods, assessing its clinical feasibility, safety profile, and therapeutic efficacy in the management of patients with malignant obstructive jaundice. Methods A cohort of 165 patients with malignant obstructive jaundice, who were admitted to our hospital between January 2018 and February 2024, was retrospectively reviewed and randomly allocated into two groups. Group A, comprising 59 patients, underwent the conventional implantation procedure for the combined biliary stent and ¹²⁵ I seeds strand. In contrast, Group B, consisting of 49 patients, received the same combination therapy but utilizing the novel, refined implantation technique. The primary endpoints for comparison between the two cohorts included therapeutic efficacy, the incidence of intraoperative and postoperative complications, duration of stent patency, and overall patient survival. For all statistical analyses, a p-value of less than 0.05 was predefined as the threshold for statistical significance. Results The procedural success rate for PTBSIS was 100% across both cohorts. One month following the intervention, comparative analysis with pre-PTBD baseline levels demonstrated a statistically significant improvement in liver function parameters for all patients (P < 0.001). Notably, when comparing the two groups at this one-month mark, no significant intergroup differences were observed in key hepatic indices, including ALT, AST, and TBIL levels (P > 0.05). However, subsequent analysis confirmed that the incidence of procedure-related complications was significantly higher in Group A compared to Group B, a finding that held true for both intraoperative and postoperative events (P < 0.05). Furthermore, long-term outcomes strongly favored the innovative approach. Patients in Group B achieved a markedly longer median stent patency time and a superior overall median survival period, with both differences being statistically highly significant (P < 0.001). Conclusions The refined fabrication technique and novel implantation methodology for the ¹²⁵ I seeds strand, when combined with biliary stenting, constitutes a safe and effective therapeutic strategy for malignant obstructive jaundice. Compared to the conventional approach, this optimized intervention significantly mitigates procedure-related complications, while concurrently extending both stent patency and overall patient survival, thereby offering a superior clinical outcome. Trial registration This clinical trial was approved by The First Affiliated Hospital of Anhui Medical University (LLSC20221301) and registered in the Clinical Trials (NCT07381439, registered on January 14, 2026). Retrospectively registered.