A Prospective, Randomized Controlled Trial Comparing Conventional Linear Versus Novel Spiral Iodine-125 Seed Strand Implantation Combined With Metallic Stent for Malignant Obstructive Jaundice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Stent Patency Time
研究概览
简要总结
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.
详细描述
Malignant obstructive jaundice often requires palliative drainage with self-expanding metallic stents. Combining stents with brachytherapy using Iodine-125 (^125^I) seed strands has been shown to prolong stent patency and patient survival compared to stenting alone. The conventional technique implants a linear seed strand between the stent and the bile duct wall, which is associated with risks of hemobilia, biliary fistula, and peritonitis due to the need for a larger puncture tract. This prospective, randomized controlled trial aimed to evaluate a novel, refined method involving a spiral-configured ^125^I seed strand implanted within the stent lumen, hypothesizing that it would reduce procedure-related complications while maintaining or improving therapeutic efficacy.
Study Design and Methods:
This was a single-center, prospective, randomized controlled trial. From January 2018 to February 2024, 105 patients with inoperable malignant obstructive jaundice were enrolled and randomly allocated into two groups.
Group A (Conventional, n=59): Received a straight ^125^I seed strand implanted between the metallic stent and the bile duct wall.
Group B (Novel, n=46): Received a spiral ^125^I seed strand implanted within the lumen of the metallic stent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients with a definitive diagnosis of Malignant Obstructive Jaundice (MOJ) confirmed by imaging (enhanced CT/MRCP), laboratory tests, and/or pathology.
- •2. Assessed by a multidisciplinary team as not a candidate for curative surgical resection.
- •3. No absolute contraindications for the combined implantation of a biliary metallic stent and an ^125^I seeds strand (e.g., severe coagulation dysfunction, significant renal impairment, or uncontrolled serious cardiovascular/cerebrovascular diseases).
- •4. Willing and able to provide written informed consent.
排除标准
- •Obstructive jaundice attributable to benign etiology.
- •Presence of any absolute contraindication listed in the inclusion criteria.
- •Life expectancy estimated to be less than three months.
- •Unwillingness to participate in the study or provide informed consent.
研究组 & 干预措施
Conventional linear implantation
In this group, participants received percutaneous transhepatic biliary stenting combined with a straight-configured ^125^I seed strand. The strand was fabricated by loading the prescribed number of ^125^I seeds into a 4F catheter, the ends of which were subsequently heat-sealed. During the procedure, after the deployment of a self-expanding metallic stent across the malignant stricture, the straight seed strand was implanted and fixed in the space between the outer wall of the stent and the bile duct wall to deliver localized brachytherapy.
干预措施: Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand (Radiation)
Novel spiral implantation
In this group, participants received percutaneous transhepatic biliary stenting combined with a spiral-configured ^125^I seed strand. The strand was fabricated by first preparing a linear catheter strand and then shaping it into a spiral configuration using boiling water. A slightly higher number of seeds were used to compensate for foreshortening. During the procedure, after stent deployment, the spiral seed strand was implanted and secured within the inner lumen of the metallic stent. This method was designed to reduce tract-related injury by utilizing a single, smaller working sheath and minimizing manipulation of the bile duct wall.
干预措施: Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand (Radiation)
结局指标
主要结局
Stent Patency Time
时间窗: 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.
The duration from the date of stent placement to the date of first documented stent re-obstruction (confirmed by imaging evidence of restenosis or occlusion). For patients who die without prior evidence of recurrent jaundice, the data will be censored at the date of death.
Overall Survival
时间窗: From the date of randomization/stent placement until the date of death from any cause, assessed up to 24 months.
The time from the date of the stent placement procedure until the date of death from any cause. For patients who are alive at the end of the study, survival data will be censored at the date of the last follow-up contact.
次要结局
- Incidence of Procedure-Related Complications(Intraoperative period and up to 30 days after the procedure.)
- Change in Serum Total Bilirubin (TBIL) Level(Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.)
- Change in Serum Alanine Aminotransferase (ALT) Level(Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.)
- Change in Serum Aspartate Aminotransferase (AST) Level(Baseline (pre-PTBSIS, after initial PTBD) and 1 month after the PTBSIS procedure.)
- Technical Success Rate(Assessed immediately upon completion of the stent and seed strand implantation procedure.)
研究者
Peng, Zhaohong
Associate Chief Physician
The First Affiliated Hospital of Anhui Medical University