Clinical trial · Interventional
Comparison of Two Seed Strand Implantation Techniques for Biliary Cancer
A Prospective, Randomized Controlled Trial Comparing Conventional Linear Versus Novel Spiral Iodine-125 Seed Strand Implantation Combined With Metallic Stent for Malignant Obstructive Jaundice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Obstructive Jaundice | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand | Radiation | — | UNRESOLVED |
| Percutaneous transhepatic biliary stenting with novel spiral ^125^I seeds strand | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Conventional linear implantation
- description
- 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.
- interventionNames
- Radiation: Percutaneous transhepatic biliary stenting with conventional linear ^125^I seeds strand
- type
- EXPERIMENTAL
- label
- Novel spiral implantation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: 1. Obstructive jaundice attributable to benign etiology. 2. Presence of any absolute contraindication listed in the inclusion criteria. 3. Life expectancy estimated to be less than three months. 4. Unwillingness to participate in the study or provide informed consent.
References
Publications (3)
- RESULTWang W, Shen J, Wang C, Ren B, Zhu X, Ni C. Safety and Feasibility of Helical I-125 Seed Implants Combined with Transcatheter Arterial Chemoembolization in Hepatocellular Carcinomas with Main Portal Vein Tumor Thrombus. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1420-1428. doi: 10.1007/s00270-019-02256-z. Epub 2019 Jun 11. PMID 31187228
- RESULTJang S, Stevens T, Parsi MA, Bhatt A, Kichler A, Vargo JJ. Superiority of Self-Expandable Metallic Stents Over Plastic Stents in Treatment of Malignant Distal Biliary Strictures. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e182-e195. doi: 10.1016/j.cgh.2020.12.020. Epub 2020 Dec 18. PMID 33346140
- RESULTLarghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol. 2008 Feb;103(2):458-73. doi: 10.1111/j.1572-0241.2007.01645.x. Epub 2007 Nov 19. PMID 18028506