This study aimed to compare the safety and effectiveness of two different methods for fabricating and implanting Iodine-125 (\^125\^I) radioactive seed strands combined with a metal stent for treating malignant obstructive jaundice. The conventional method uses a straight seed strand placed between the stent and the bile duct wall. A novel technique was developed that uses a spiral-shaped seed strand placed inside the stent lumen. Between January 2018 and February 2024, 105 patients were randomly assigned to two groups. Group A (59 patients) received the conventional straight strand, while Group B (46 patients) received the novel spiral strand. The study compared therapeutic efficacy, the incidence of intraoperative and postoperative complications, stent patency duration, and patient survival. Both methods successfully improved liver function. However, the novel spiral technique (Group B) caused significantly fewer complications, such as bile leakage and peritonitis, compared to the conventional method (Group A). Importantly, patients in Group B also had longer stent patency (305 days vs. 277 days) and longer overall survival (345 days vs. 300 days). In conclusion, the novel spiral seed strand implantation technique is a safer and more effective treatment option for malignant obstructive jaundice.
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Stent Patency Time
Timeframe: From the date of randomization/stent placement until the date of documented stent re-obstruction or death from any cause, whichever occurs first, assessed up to 24 months.
Overall Survival
Timeframe: From the date of randomization/stent placement until the date of death from any cause, assessed up to 24 months.