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EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study (EUS)

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ClinicalTrials.gov Identifier: NCT01902238
Recruitment Status : Unknown
Verified November 2016 by Do Hyun Park, Asan Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 18, 2013
Last Update Posted : December 1, 2016
Sponsor:
Collaborator:
Dankook University
Information provided by (Responsible Party):
Do Hyun Park, Asan Medical Center

Brief Summary:
The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

Condition or disease Intervention/treatment Phase
Efficacy Safety Feasibility Procedure: EUS-guided ethanol-lipiodol mixture ablation Not Applicable

Detailed Description:
Pancreatic neuroendocrine tumor, including insulinoma, increasingly are being encountered in clinical practice. Management of pancreatic NET is challenging because most are asymptomatic but may have malignant potential, and surgical resection of pancreatic neoplasm is associated with substantial morbidity of 20%-40% and a mortality rate of 2%. Management strategy needs to be individualized, applying a risk-benefit analysis to each patient. Recently, pancreatic tissue ablation by EUS-guided injection of ethanol or other chemotherapeutic agents can be performed safely, with few procedure-related complications. Levy et al. demonstrated that EUS-guided ethanol ablation for insulinoma was both safe and feasible, and symptomatic improvement was achieved in 8 of 8 patients (100%). However, previous study have included only a small number of patients and evaluated only short-term outcomes. In addition, lipiodol permits the drug to concentrate in the tumor. To obtain an embolic effect and prevent washout of the ethanol, ethanol/lipiodol mixture is administered into the tumor. The present study evaluate the safety and efficacy of EUS-guided ethanol-lipiodol ablation for the treatment of pancreatic NET

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome
Study Start Date : July 2013
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: EUS-guided ethanol-lipiodol mixture ablation
By using 3D-volumetric analysis, the optimal volume of ethanol is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol/lipiodol (1:1 mixture), typically 1 to 1.5 ml.
Procedure: EUS-guided ethanol-lipiodol mixture ablation
By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml.




Primary Outcome Measures :
  1. Number of participants with treatment response [ Time Frame: more than 3 years after procedure ]
    Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure


Secondary Outcome Measures :
  1. The number of participants with post-procedure adverse events [ Time Frame: until 3 months after procedure ]
    Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection


Other Outcome Measures:
  1. Technical feasibility [ Time Frame: at the time of procedure ]
    Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pancreas NET(including insulinoma) < 2cm in diameter
  • Poor surgical candidate (involving the head of the pancreas or multifocal NET, advanced comorbidity, age >75 years of age)
  • Refuse to surgery

Exclusion Criteria:

  • Younger than 18 years of age
  • Coagulopathy (INR >1.5, Platelet <50,000)
  • Evidence of active pancreatitis
  • Inability to safely undergo EUS
  • Refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902238


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Dankook University
Investigators
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Study Director: Do Hyun Park, MD, PhD Asan Medical Center, Seoul, Korea, Republic of

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Responsible Party: Do Hyun Park, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01902238     History of Changes
Other Study ID Numbers: NET ETHANOL
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Do Hyun Park, Asan Medical Center:
neuroendocrine tumor
ethanol
endoscopic ultrasonography

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adenoma, Islet Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenoma
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ethanol
Ethiodized Oil
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antineoplastic Agents