Neuroendocrine TumorsNCT02882503
Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
A study testing endoscopic ultrasound - radiofrequency ablation (EUS-RFA) in people with Neuroendocrine Tumors and Cystic Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Neuroendocrine Tumors, Cystic Neoplasms
- What is being tested?
- endoscopic ultrasound - radiofrequency ablation (EUS-RFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2016to 7 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuroendocrine Tumors, Cystic Neoplasms
- Being tested
- endoscopic ultrasound - radiofrequency ablation (EUS-RFA)
- Keywords
- Endoscopic ultrasound, Radiofrequency ablation, Pancreas
- Medical subject headings
- Neuroendocrine Tumors, Neoplasms, Cystic, Mucinous, and Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: endoscopic ultrasound - radiofrequency ablation (EUS-RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pancreatic tumor ablation effect
Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)
Measured: up to one year
Secondary outcomes (4)
Symptom and adverse event monitoring
monitor any side effects
Measured: up to one year
Physical examination
Complete an Eastern Cooperative Oncology Group (ECOG) evaluation
Measured: up to one year
Blood Routine (CBC)
measure of the concentration of white blood cells, red blood cells, and platelets in the blood.
Measured: up to one year
Biochemical profile
including CEA/CA19-9, amylase, glucose
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJun 2016
- Primary completion7 May 2019 (estimated)
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882503
- Sponsor's protocol ID
- 201604063DIPC
- Status last verified
- Jun 2019
- First submitted
- 24 Aug 2016
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Small Benign Pancreatic Tumors
- ClinicalTrials.gov ID
- NCT02882503
- Acronym / sponsor ID
- 201604063DIPC
- Conditions
- Neuroendocrine Tumors, Cystic Neoplasms
- Keywords
- Endoscopic ultrasound, Radiofrequency ablation, Pancreas
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 7 May 2019 (estimated)
- Study completion
- 7 May 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-RFA | Experimental | Device: endoscopic ultrasound - radiofrequency ablation (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 |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must meet all of the following inclusion criteria to be eligible for this study:
Key exclusion criteria (14 listed)
- Patients presenting with any of the following will not be enrolled into this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | EUS-RFA |
Primary outcome
To evaluate pancreatic tumor ablation effect
Time frame: up to one year
Using magnetic resonance cholangiopancreatography (MRCP) and/or abdominal computed tomography (CT)
4 secondary outcomes
Symptom and adverse event monitoring
Time frame: up to one year
Physical examination
Time frame: up to one year
Blood Routine (CBC)
Time frame: up to one year
Biochemical profile
Time frame: up to one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai-Wen Huang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound - radiofrequency ablation (EUS-RFA) in people with Neuroendocrine Tumors and Cystic Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate pancreatic tumor ablation effect (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.