Clinical trial · Interventional
Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment
Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Oct 1, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20261001-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) affects survival in patients with inoperable pancreatic carcinoma. By using a prospective single-arm design with historical controls, this study aims to generate clinically relevant data while minimizing the number of patients exposed to experimental treatment. The findings may support future integration of EUS-RFA into standard care for this high-need patient population.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound-guided radiofrequency ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS-RFA plus standard oncological treatment
- description
- Participants receive endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) using a 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) connected to an RF generator, as a supplement to standard palliative oncological treatment. EUS-RFA is performed under deep sedation or general anesthesia and may be repeated at approximately 4-week intervals contingent on patient condition. All participants continue standard oncological follow-up, including systemic therapy and regular cross-sectional imaging, in parallel with the study intervention.
- interventionNames
- Procedure: Endoscopic ultrasound-guided radiofrequency ablation
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From index date until death from any cause, assessed up to 4 years
- description
- Time from index date (first day of systemic oncological therapy or first visit at the Department of Oncology (for patients who do not receive systemic therapy)) to death from any cause. Participants alive at the time of last follow-up will be censored at that date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult habile patients with a signed informed consent * Histologically confirmed pancreatic carcinoma ≤5 cm in largest diameter * ECOG performance status 0-2 * Patients not eligible for curative-intended surgical treatment due to: Advanced (unresectable) disease, or Unsuitability for surgery due to comorbidities or poor performance status, or Patient preference to decline surgery Exclusion Criteria: * Metastatic disease * Uncorrected coagulopathy (INR ≥1.5 or thrombocyte count \< 50 mia/L) * Altered anatomy or interposition of major vessels precluding safe EUS-RFA * Active untreated infection or pancreatitis * Life expectancy \<3 months * Prior local ablative treatment interfering with outcome
References
Publications (0)
Data not yet available