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

NCT02882503 | Withdrawn DMC

• 1 other identifier: 201604063DIPC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; Cystic Neoplasms

Keywords

Endoscopic ultrasound; Radiofrequency ablation; Pancreas

Outcome Measures

Primary Outcomes (1)

• To evaluate pancreatic tumor ablation effect

  Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)

  up to one year

Secondary Outcomes (4)

• Symptom and adverse event monitoring

  up to one year

• Physical examination

  up to one year

• Blood Routine (CBC)

  up to one year

• Biochemical profile

  up to one year

Study Arms (1)

EUS-RFA

EXPERIMENTAL

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)

Interventions

endoscopic ultrasound - radiofrequency ablation (EUS-RFA) DEVICE

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.

EUS-RFA

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Normal physical condition. Eastern Cooperative Oncology Group (ECOG) score of 0-2 and American Society of Anaesthesiologists (ASA) score ≤ 3.
• Normal blood coagulation. Platelet count ≥ 100 K/Μl. Prothrombin time (PT)- international normalized ratio (INR) ≦ 1.5.
• Prior Informed Consent Form.
• Life expectancy of at least 3 months.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasms, Cystic, Mucinous, and Serous

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplasms, Glandular and Epithelial

Study Officials

• Kai-Wen Huang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 30, 2016
• Study Start: June 1, 2016
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)