Clinical trial · Interventional
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
Intraluminal Implantation of Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer
NCT02238613CI-TRIAL-00015594unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Carcinoma | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Biliary Obstruction | — | UNRESOLVED | — |
| Cholangiocarcinoma of the Extrahepatic Bile Duct | Cholangiocarcinoma | PROBABILISTIC | 0.70 |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| plastic stent | Device | — | UNRESOLVED |
| radioactive stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- radioactive stent
- description
- The radioactive stent carrying seeds iodine 125 is made of Polytetrafluoroethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the irradiation group patients.
- interventionNames
- Device: radioactive stent
- type
- OTHER
- label
- plastic stent
- description
- The plastic stent is made of polyethylene. It will be implanted in the common bile duct by ERCP(endoscopic retrograde cholangiopancreatography) of the conventional group patients.
- interventionNames
- Device: plastic stent
Primary outcomes (1)
- measure
- Tumor Response rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma) * Patients aged between 18 and 80 years * an estimated life expectancy of more than 3 months * Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria * TNM stage III-IV * no evidence of cancer of another organ. * no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed * Karnofsky index of ≥60% * ECOG index ≥2 * previous technically successful stenting or ENBD derange * Accept of informed consent Exclusion Criteria: * Clinically significant cardiovascular disease * coagulation disorders * contraindication of Endoscopic * pregnant or breastfeeding women * known sensitivity sensitivity to investigated agents or components * recent invasive procedure * prior chemotherapy or radiotherapy for biliary cancer * refusal of informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.