Endoscopic Ultrasound-Guided Radiofrequency Ablation for Pancreatic Cystic Neoplasms and Pancreatic Neuroendocrine Tumors
Recruiting · NCT07536087 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute for Clinical and Experimental Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Consensual indication to EUS-guided RFA treatment made in a multidisciplinary team
- Capability of giving informed consent PCN Inoperability or refusal of surgery
- Branch duct IPMN (BD-IPMN) with worrisome features:
- Jaundice
- High grade dysplasia or cancer
- Solid mass/nodule \> 5mm
- Main pancreatic duct dilation \> 10mm Or at least one (patients without comorbidities) or at least two (patient with comorbidities) of the following risk features:
- CA 19-9\> 37 U/ml
- Increase in size \> 5mm/year
- Dilation of the main pancreatic duct between 5-10mm
- Size ≥ 40mm
- Symptoms (new onset of diabetes, acute pancreatitis)
- Nodule \< 5mm Pancreatic NET
- Size \< 2 cm
- Histological proof in non-functional lesions/histological proof or clinical proof in functional lesions
- 68Ga-DOTATATE PET/CT positive for a pancreatic lesion and negative for lymph nodes, liver, and other distant metastases
- G1 or G2 (\<5 %) histology
Exclusion criteria
- 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
- Inability to sign the informed consent
Where it is running
1 location listed.
- Institute for Clinical and Experimental Medicine, Department of Gastroenterology and Hepatology - Prague, Czechia