Pancreatic Neoplasms Clinical Trial
Official title:
Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic Neoplasms
NCT number | NCT03218345 |
Other study ID # | CRE-2015.531T |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | May 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Surgery, Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severe adverse events | Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak, thermal injury | 30 days | |
Secondary | Technical success rates | defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle. | 1 week | |
Secondary | Procedural times | Duration of the procedure | 1 day | |
Secondary | Hospital stay | Duration of hospital stay | 30 days | |
Secondary | Radiological response | Based on modified RECIST criterion | 1 year | |
Secondary | Number of re-interventions | Number of re-interventions after the procedure | 1 year | |
Secondary | Survival | Duration of survival after the procedure | 3 years |
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