Clinical trial · Interventional
Combined Stent Insertion and HIFU Ablation for Pancreatic Carcinoma With Biliary Obstruction
Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Pancreatic Carcinoma With Biliary Obstruction
NCT03962478CI-TRIAL-00047408HIFUcompletedN/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 compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.
Conditions
Conditions (2)
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 Obstruction | — | UNRESOLVED | — |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biliary stent | Device | — | UNRESOLVED |
| biliary stent and high-intensity focused ultrasound ablation system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stent with high-intensity focused ultrasound ablation
- description
- Patients undergo stent insertion with high-intensity focused ultrasound ablation on day 1.
- interventionNames
- Device: biliary stent and high-intensity focused ultrasound ablation system
- type
- ACTIVE_COMPARATOR
- label
- Stent without high-intensity focused ultrasound ablation
- description
- Patients undergo stent insertion on day 1.
- interventionNames
- Device: biliary stent
Primary outcomes (1)
- measure
- 6-month survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. malignant distal biliary obstruction; 2. pathologically diagnosed pancreatic carcinoma; 3. unresectable cases. Exclusion Criteria: 1. inability to obtain informed consent; 2. Eastern Cooperative Oncology Group performance status of 4; 3. life expectancy of 3 months or less; 4. biliary obstruction that was not directly caused by pancreatic carcinoma.
References
Publications (2)
- BACKGROUNDNiu S, Cheng L, Qiao Y, Fu YF, Cao C. Combined Stent Insertion and High-intensity Focused Ultrasound Ablation for Patients With Malignant Obstructive Jaundice. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):488-492. doi: 10.1097/SLE.0000000000000327. PMID 27783026
- DERIVEDZhang FQ, Li L, Huang PC, Xia FF, Zhu L, Cao C. Stent Insertion With High Intensity-Focused Ultrasound Ablation for Biliary Obstruction Caused by Pancreatic Carcinoma: A Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2021 Feb 17;31(3):298-303. doi: 10.1097/SLE.0000000000000918. PMID 33605677