Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors

A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors

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.

Study Overview

• Status: Withdrawn
• Conditions: Neuroendocrine Tumors; Cystic Neoplasms
• Intervention / Treatment: Device: endoscopic ultrasound - radiofrequency ablation (EUS-RFA)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-RFA; monopolar radiofrequency probe (1.2 mm Habib endoscopic ultrasound - radiofrequency ablation (EUS-RFA) catheter) and 19 or 22 gauge fine needle aspiration (FNA) needle	Device: endoscopic ultrasound - radiofrequency ablation (EUS-RFA); Radiofrequency ablation will be 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 in patients with a tumor in the head of the pancreas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate pancreatic tumor ablation effect	Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)	up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom and adverse event monitoring	monitor any side effects	up to one year
Physical examination	Complete an Eastern Cooperative Oncology Group (ECOG) evaluation	up to one year
Blood Routine (CBC)	measure of the concentration of white blood cells, red blood cells, and platelets in the blood.	up to one year
Biochemical profile	including CEA/CA19-9, amylase, glucose	up to one year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Kai-Wen Huang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): May 7, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pancreas; Endoscopic ultrasound; Radiofrequency ablation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Pancreatic Neoplasms; Neuroendocrine Tumors
• Other Study ID Numbers: 201604063DIPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No