Clinical trial NCT02882503: Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
Official title: A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neuroendocrine Tumors
Cystic Neoplasms
Keywords: Endoscopic ultrasound
Radiofrequency ablation
Pancreas
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Incidental pancreatic solid or cystic lesions are diagnosed with increased frequency due to the widespread use of abdominal cross-sectional imaging to investigate unrelated symptoms. Lesions such as neuroendocrine tumors (NET), mucinous cystadenomas and intraductal papillary mucinous neoplasms (IPMNs) have the potential of malignant transformation. The standard treatment of solid or cystic pancreatic lesions with malignant potential has been surgical resection, with lesions in the pancreatic head requiring a Whipple resection whereas pancreatic tail lesions are treated with distal pancreatectomy. Both types of resection carry significant morbidity and mortality. The study would like to outline the feasibility, safety, adverse events and early results of endoscopic ultrasound (EUS) - radiofrequency ablation (RFA) in pancreatic neoplasms.

Detailed description: The intervention described was radiofrequency ablation which was applied with an innovative monopolar radiofrequency probe (1.2 mm Habib EUS-RFA catheter) placed through a 19 or 22 gauge fine needle aspiration (FNA) needle once FNA was performed in patients with a tumor in the head of the pancreas. The device had been certificated by the European Union (EU) and received Food and Drug Administration (FDA) approval in 2015. The endoscopic ultrasound (EUS) - radiofrequency ablation (RFA) is a 1 Fr wire with a working length of 190 cm, which can be inserted through the biopsy channel of a EUS. RF power is applied to the electrode at the end of the wire to coagulate tissue in the liver and pancreas. In this study, the investigators will enroll 20 patients to receiving EUS-RFA of pancreatic neoplasms with the monopolar RF probe. The follow-up period will be one year with regular monitoring. Our primary endpoint will be to evaluate pancreatic tumor ablation effect, Secondary objectives will be to evaluate the mortality and morbidity.

Eligibility criteria: Inclusion Criteria:

* Patients must meet all of the following inclusion criteria to be eligible for this study:

  1. Cystic neoplasms in pancreatic parenchyma or outer portion of the pancreas are defined by radiologists who evaluate the images more than twice in three months. The size of benign cystic neoplasm is between 0.5-3 cm. Or surgical specialist physician considers the benign tumor that larger than 3 cm is not suitable for surgery or patients unwilling to accept surgery.
  2. Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score ≤ 3.
  3. Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)- international normalized ratio (INR) ≦ 1.5.
  4. Prior Informed Consent Form.
  5. Life expectancy of at least 3 months.

Exclusion Criteria:

* Patients presenting with any of the following will not be enrolled into this study:

  1. Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception.
  2. To participate in any related tumor therapy clinical trials within thirty days prior to surgery.
  3. Any active metal implanted device (eg Pacemaker)
  4. Patients who have other malignancies and have not been cured within five years.
  5. Patients with resectable pancreatic cancer.
  6. Simple pancreatic cysts (including pseudocysts) or serous cystadenoma.
  7. Cystic part of the tumor is close to blood vessels or bile duct (\<0.5 cm) that might injury the related structure.
  8. Cystic pancreatic tumors originate from or associate the pancreatic ducts.
  9. Have acute pancreatitis in the past four weeks
  10. Known history of human immunodeficiency virus (HIV) infection
  11. Have cardiovascular diseases (such as acute myocardial infarction, or stroke) within the last three months
  12. Moderate to severe renal dysfunction (Estimated Glomerular Filtration Rate (eGFR) \<60)
  13. Have any serious or poor control of systemic disease that are not suitable for this test and followup

Primary outcomes:
measure: To evaluate pancreatic tumor ablation effect
timeFrame: up to one year
Secondary outcomes:
measure: Symptom and adverse event monitoring
timeFrame: up to one year
measure: Physical examination
timeFrame: up to one year
measure: Blood Routine (CBC)
timeFrame: up to one year
measure: Biochemical profile
timeFrame: up to one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Kai-Wen Huang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: