EUS-guided radiofrequency ablation for pancreatic tumors
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms
This study is testing a new heat-based treatment for pancreatic tumors in patients who can't have surgery to see if it is safe and effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03218345 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of EUS-guided radiofrequency ablation (RFA) for treating solid pancreatic neoplasms in patients who are not suitable for surgery. The procedure involves using a high-frequency alternating current to generate heat, leading to tissue destruction and potential tumor reduction. Conducted at multiple high-volume international institutions, the study aims to assess adverse events, technical success, and survival rates among participants. Patients with pancreatic neuroendocrine tumors or pancreatic ductal carcinoma under 5 cm will be recruited for this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with pancreatic neuroendocrine tumors or pancreatic ductal carcinoma under 5 cm who are deemed unsuitable for surgical intervention.
Not a fit: Patients with coagulopathy, pregnancy, severe mental conditions, or those unwilling to participate in follow-up assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a minimally invasive option for patients with pancreatic tumors who cannot undergo surgery.
How similar studies have performed: Previous studies have shown that EUS-guided RFA is feasible and effective in treating solid tumors, indicating potential success for this approach in pancreatic neoplasms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years-old or above * Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (\<5cm in largest diameter) that was confirmed by fine needle aspiration cytology * Unsuitable for surgery, due to one (or more) of the following items: * ASA score \> II\* * An alternative advanced malignancy * Unsuitable for surgery upon expert's opinion for any other reason * Healthy individuals who are not keen for surgical resection * Eligible for endoscopic intervention * Written informed consent Exclusion Criteria: * Coagulopathy (international normalized ratio \>1.3, partial thromboplastin time greater than twice that of control), platelet count \<50,000x103/uL * Pregnancy * Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study * Patients unwilling to undergo follow-up assessments * Patients with liver cirrhosis, portal hypertension and/or gastric varices.
Where this trial is running
Hong Kong
- Department of Surgery, Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Anthony YB Teoh, Professor — Chinese University of Hong Kong
- Study coordinator: Anthony YB Teoh, Professor
- Email: anthonyteoh@surgery.cuhk.edu.hk
- Phone: 26322956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.