Clinical trial · Interventional
Endoscopic Therapy of Malignant Bile Duct Strictures
Endoscopic Therapy of Malignant Bile Duct Strictures: A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
Patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. Placement of the stent is the palliative care for these patients. However over 50% of the stents get blocked within 6-8 months. Use of the radiofrequency ablation before the stent placement may improve stent patency. Heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. The investigators are looking to see how safe and feasible RFA (Radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Obstruction of Biliary Tree | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation catheter (Habib EndoHBP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Radiofrequency ablation catheter
- interventionNames
- Device: Radiofrequency ablation catheter (Habib EndoHBP)
Primary outcomes (1)
- measure
- Safety: Number of Bile Leak After RFA Procedure
- timeFrame
- 2 years
- description
- Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)
Secondary outcomes (2)
- measure
- Feasibility: Ease of the Radiofrequency Ablation Catheter Placement
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented malignant biliary obstruction requiring ERCP guided stenting Exclusion Criteria: * Coagulopathy (INR \> 2.0 or PTT \> 100 sec or platelet count \< 50,000) * Evidence of high-grade symptomatic duodenal obstruction * Poor performance status * Active suppurative cholangitis * Complex stenoses will not be eligible for the trial * Patients without access to duodenum or ampulla are not candidates for ERCP and stenting * Candidates for a Whipple resection * Patients who do not speak English
References
Publications (0)
Data not yet available