Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT)
Pancreatic Endoscopic Ultrasound-guided RadioFrequency for Inoperable Carcinoma Treatment (PERFECT Study)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Clara Søndersted, MD
- Numéro de téléphone: 45 38683868
- E-mail: clara.theodora.soendersted@regionh.dk
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: EUS-RFA plus standard oncological treatment
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. |
A 19G RFA needle (EUSRA, STARMed, Gyeonggi-do, South Korea) is introduced through the working channel of an echoendoscope and advanced into the pancreatic tumor under real-time ultrasound guidance. The needle is connected to a dedicated RF generator delivering a current of 400-500 kHz, which induces coagulative necrosis in the targeted tissue. Treatment is continued until complete ablation is confirmed ultrasonographically, or until an impedance value of 800 Ω is reached, at which point the generator automatically terminates power output to limit further tissue damage. A cooling pump circulates chilled saline through the needle to reduce charring at the ablation site. The procedure is performed transgastrically or transduodenally under deep sedation or general anesthesia, and may involve one or more ablation cycles per session. Treatment may be repeated at approximately 4-week intervals, depending on radiological response and patient tolerance.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall survival
Délai: From index date until death from any cause, assessed up to 4 years
|
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. |
From index date until death from any cause, assessed up to 4 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression- and metastatic-free survival
Délai: From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
|
Time from index date to radiological progression of the primary tumor or development of distant metastases, assessed according to RECIST 1.1 on cross-sectional imaging. |
From index date until progression, metastasis, or last follow-up, assessed up to approximately 4 years
|
|
Local tumor control at 6 and 12 months
Délai: At 6 and 12 months after index date
|
Proportion of participants with local tumor control (absence of local progression) on cross-sectional imaging at 6 and 12 months, assessed according to RECIST 1.1. |
At 6 and 12 months after index date
|
|
Procedure-related adverse events
Délai: At 30 days after each EUS-RFA procedure
|
Adverse events occurring within 30 days of each EUS-RFA treatment, graded according to the AGREE classification. |
At 30 days after each EUS-RFA procedure
|
|
Time to biliary/duodenal intervention
Délai: From index date until intervention or last follow-up, assessed up to approximately 4 years
|
Time from index date to first biliary or duodenal intervention (e.g., stenting) |
From index date until intervention or last follow-up, assessed up to approximately 4 years
|
|
Pain score change compared to baseline
Délai: Baseline and at 6, 12 and 18 months after inclusion
|
Change from baseline in pain severity, measured using a Numeric Rating Scale (NRS, 0-10) |
Baseline and at 6, 12 and 18 months after inclusion
|
|
Opioid consumption change compared to baseline
Délai: Baseline and at 6, 12 and 18 months after inclusion
|
Change in opioid consumption, converted to total daily oral morphine milligram equivalent (MME). |
Baseline and at 6, 12 and 18 months after inclusion
|
|
Quality of Life change compared to baseline (EORTC QLQ-C30)
Délai: Baseline and at 6, 12 and 18 months
|
Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Global Health Status/Quality of Life scale, ranging from 0 (worst) to 100 (best), with higher scores indicating better quality of life. |
Baseline and at 6, 12 and 18 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Bojan Kovacevic, MD, PhD, Herlev Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 16-0302-148
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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