Clinical trial · Interventional
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture
An Unicentric RCT About Novel Radiation Stent Versus Nitinol SEMS for Palliative Treatment of Malignant Biliary Stricture
- 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 is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.
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 |
|---|---|---|---|
| Cholangiocellular Carcinoma | Cholangiocarcinoma | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Carcinoma | Carcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| self-expandable 125I radioactive seeds-loaded-stent | Device | — | UNRESOLVED |
| self-expandable biliary nitinol alloys stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- novel radiation stent
- description
- Patients undergo placement of a novel biliary stent loaded with 125I seeds on day 1. Intervention: Device: self-expandable 125I radioactive seeds-loaded-stent
- interventionNames
- Device: self-expandable 125I radioactive seeds-loaded-stent
- type
- EXPERIMENTAL
- label
- conventional stent
- description
- Patients undergo placement of a conventional nitinol SEMS on day1. Intervention: Device: self-expandable biliary nitinol alloys stent
- interventionNames
- Device: self-expandable biliary nitinol alloys stent
Primary outcomes (1)
- measure
- Overall Mean Survival and Median Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years old or older * Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures * Clinical symptoms of biliary obstruction * Unresectable or refused to be surgically treated biliary obstruction by any malignant process * Willing and able to comply with the study procedures and provide written informed consent to participate in the study Exclusion Criteria: * Suspected benign bile duct stricture * Strictures that can not be dilated enough to pass the delivery system * Perforation of any duct within the biliary tree * Presence metallic biliary stent or bile duct surgery * Patients for whom PTC procedures are contraindicated * Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver * Noncooperation or no authorization and signature
References
Publications (0)
Data not yet available