Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine

About this trial

The primary aim of this study is to evaluate the technical feasibility and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) in the treatment of pancreatic cystic neoplasms (PCNs) and pancreatic neuroendocrine tumors (pNETs) in patients who are not suitable candidates for surgical treatment or who refuse surgery.

EUS-RFA, as a minimally invasive therapeutic option, may potentially reduce the need for intensive imaging surveillance, prevent further progression of these lesions, and serve as a bridging therapy in selected patients for whom surgical intervention may be considered in the future. At the same time, EUS-RFA could contribute to reducing overtreatment, thereby lowering the risk of complications associated with surgical procedures and leading to an overall reduction in healthcare costs.

The secondary objectives of the study are to evaluate the safety profile of EUS-RFA, including the incidence and severity of adverse events both in the early postoperative period and during the first year of follow-up, as well as to assess the long-term efficacy of EUS-RFA, including disease progression.

Eligibility criteria

Qualifiers

Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team

Capability of giving informed consent PCN Inoperability or refusal of surgery

Jaundice

High grade dysplasia or cancer

Disqualifiers

Known bleeding disorder that cannot be sufficiently corrected with medication

Use of anticoagulants that cannot be discontinued

Physical and/or psychological inability to understand the aims of the research and to adequately cooperate

Pregnancy

Trial design

Treatments tested in this trial

  • Endoscopic ultrasound-guided radiofrequency ablation for pancreatic cystic lesions
  • Endoscopic ultrasound-guided radiofrequency ablation of pancreatic solid lesions

Treatment groups

50 Participants
are divided into 2 treatment groups