Locally advanced unresectable pancreatic ductal adenocarcinoma Radiofrequency ablation Endoscopic ultrasound Locally advanced pancreatic cancer
Conditions
Interventions
The device would be EG-3870K: Pentax Corporation and Ultrasound Scanner NOBLUS: Hitachi with Monopolar RFA generator (STARmed, Koyang, Korea) and 19G RFA needle (EUSRAtm). The power setting would be 5
EUS-guided radiofrequency ablation plus chemotherapy,Chemotherapy
Sponsors
Scholarship
Scholarship
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Histology or cytology confirmed locally advanced unresectable pancreatic ductal adenocarcinoma patients (AJCC 8th stage III) 2. ECOG status below or equal to 2 3. Age 18 - 85 years old and willing to participate in a clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients with technical restriction in performing EUS-guided radiofrequency ablation 2. Pregnant women 3. Prior received standard treatment for pancreatic cancer 4. Patients with uncorrectable coagulopathy (INR > 1.5 times upper normal limit, aPTT > 2 times upper normal limit or platelet < 50,000)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival at 6 months after end of intervention Time to death from start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival at 6 months after end of intervention Time to first progression event or death from start of treatment,Objective tumor response at 6 months after end of intervention Measured the tumor response following RECIST and mRECIST version 1.1,Multi-dimensional pain assessment From baseline up to 6 months Self-assessment brief pain inventory score and change in morphine dosage equivalent,Quality of life From baseline up to 6 months EORTC-QLQ C-30 score - PAN26,Participants with treatment adverse events From baseline up to 6 months Adverse events after treatment followed Common Terminology Criteria for Adverse Events v5.0 | — |
Countries
Thailand
Contacts
Public ContactPradermchai Kongkam
King Chulalongkorn Memorial Hospital
Outcome results
None listed