NCT07381439Completed
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 · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 14 Jan 2026
- Start date
- 1 Jan 2018
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- NCT number
- NCT07381439
What you commit to
- Study type: Interventional
- Participants enrolled: 105
- From 1 Jan 2018 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.