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

Primary Purpose

Neuroendocrine Tumors, Cystic Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
endoscopic ultrasound - radiofrequency ablation (EUS-RFA)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Endoscopic ultrasound, Radiofrequency ablation, Pancreas

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EUS-RFA

Arm Description

monopolar radiofrequency probe (1.2 mm Habib endoscopic ultrasound - radiofrequency ablation (EUS-RFA) catheter) and 19 or 22 gauge fine needle aspiration (FNA) needle

Outcomes

Primary Outcome Measures

To evaluate pancreatic tumor ablation effect
Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2016
Last Updated
July 22, 2019
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02882503
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Withdrawn
Study Start Date
June 2016 (undefined)
Primary Completion Date
May 7, 2019 (Anticipated)
Study Completion Date
May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Cystic Neoplasms
Keywords
Endoscopic ultrasound, Radiofrequency ablation, Pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-RFA
Arm Type
Experimental
Arm Description
monopolar radiofrequency probe (1.2 mm Habib endoscopic ultrasound - radiofrequency ablation (EUS-RFA) catheter) and 19 or 22 gauge fine needle aspiration (FNA) needle
Intervention Type
Device
Intervention Name(s)
endoscopic ultrasound - radiofrequency ablation (EUS-RFA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate pancreatic tumor ablation effect
Description
Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Symptom and adverse event monitoring
Description
monitor any side effects
Time Frame
up to one year
Title
Physical examination
Description
Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
Time Frame
up to one year
Title
Blood Routine (CBC)
Description
measure of the concentration of white blood cells, red blood cells, and platelets in the blood.
Time Frame
up to one year
Title
Biochemical profile
Description
including CEA/CA19-9, amylase, glucose
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for this study: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai-Wen Huang, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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