NCT03218345 EUS-guided RFA for Pancreatic Neoplasms
| NCT ID | NCT03218345 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Pancreatic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-08 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2016-08 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.
Eligibility 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.
Contact & Investigator
Anthony YB Teoh, Professor
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT03218345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03218345 currently recruiting?
Yes, NCT03218345 is actively recruiting participants. Contact the research team at anthonyteoh@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT03218345 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT03218345 clinical trial?
NCT03218345 is sponsored by Chinese University of Hong Kong. The principal investigator is Anthony YB Teoh, Professor at Chinese University of Hong Kong. The trial plans to enroll 30 participants.