Clinical trial · Interventional
I-125 Seeds Loaded Stent Insertion for Inoperable Hilar Cholangiocarcinoma
- 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)
Malignant biliary obstruction usually arise in patients suffering from primary or metastatic hepatobiliary tumors. Approximately 80% of malignant biliary obstruction patients are not eligible for surgical resection, and as such palliative stent insertion is the only treatment option available for most patients. At present, I-125 seeds loaded stent has been developed to improve the stent patency and patients' survival. Hilar malignant biliary obstruction is an important part of malignant biliary obstruction. Hilar cholangiocarcinoma is the most common disease which causes hilar malignant biliary obstruction. Herein, we assessed the clinical and long-term efficacy of I-125 seeds loaded stent insertion for hilar cholangiocarcinoma patients.
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 |
|---|---|---|---|
| Hilar Cholangiocarcinoma | Hilar Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China) | Device | — | UNRESOLVED |
| Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- I-125 seeds loaded stent group
- description
- Patients who receive the I-125 seeds loaded stent insertion
- interventionNames
- Device: I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)
- type
- ACTIVE_COMPARATOR
- label
- Normal stent group
- description
- Patients who receive the normal stent insertion
- interventionNames
- Device: Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Patients with a diagnosed hilar Cholangiocarcinoma; Inoperable cases; Patients showed evidence of obstructive jaundice; Eastern Cooperative Oncology Group performance status \< 4. Exclusion Criteria: Patients who underwent post-operative external radiotherapy; Patients in whom prior biliary stent insertion or drainage were performed; Patients suffering from serious dysfunction of the pulmonary, renal, cardiac, or coagulatory systems.
References
Publications (2)
- BACKGROUNDChen G, Zhang M, Sheng YG, Yang F, Li ZQ, Liu TG, Fu YF. Stent with radioactive seeds strand insertion for malignant hilar biliary obstruction. Minim Invasive Ther Allied Technol. 2021 Dec;30(6):356-362. doi: 10.1080/13645706.2020.1735446. Epub 2020 Mar 3. PMID 32125207
- BACKGROUNDYang S, Liu Y, Teng F, Wu AL, Lin J, Xian YT, Xu YS. Radioactive Stent Insertion for Inoperable Malignant Common Biliary Obstruction. Surg Laparosc Endosc Percutan Tech. 2020 Aug 5;31(1):61-65. doi: 10.1097/SLE.0000000000000848. PMID 32769739