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

Primary Purpose

Efficacy, Safety, Feasibility

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-guided ethanol-lipiodol mixture ablation
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficacy focused on measuring neuroendocrine tumor, ethanol, endoscopic ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EUS-guided ethanol-lipiodol mixture ablation

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment response
Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure

Secondary Outcome Measures

The number of participants with post-procedure adverse events
Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection

Full Information

First Posted
July 15, 2013
Last Updated
November 29, 2016
Sponsor
Asan Medical Center
Collaborators
Dankook University
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1. Study Identification

Unique Protocol Identification Number
NCT01902238
Brief Title
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Study
Acronym
EUS
Official Title
EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Dankook University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Efficacy, Safety, Feasibility
Keywords
neuroendocrine tumor, ethanol, endoscopic ultrasonography

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
EUS-guided ethanol-lipiodol mixture ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
EUS-guided ethanol-lipiodol mixture ablation
Intervention Description
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 Measure Information:
Title
Number of participants with treatment response
Description
Final tumor viability will be assessed using contrast enhanced CT, and EUS-guided FNA at 3 years after procedure
Time Frame
more than 3 years after procedure
Secondary Outcome Measure Information:
Title
The number of participants with post-procedure adverse events
Description
Adverse events were defined as any procedure-related complications during the procedure or within 3 months, including pancreatitis, bleeding, and peripancreatic fluid collection
Time Frame
until 3 months after procedure
Other Pre-specified Outcome Measures:
Title
Technical feasibility
Description
Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue.
Time Frame
at the time of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Organizational Affiliation
Asan Medical Center, Seoul, Korea, Republic of
Official's Role
Study Director
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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