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

EUS-guided Ethanol-lipiodol Ablation of Pancreatic Neuroendocrine Tumor: a Prospective Feasibility and Long Term Outcome

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

Study Overview

• Status: Unknown
• Conditions: Feasibility; Efficacy; Safety
• Intervention / Treatment: Procedure: EUS-guided ethanol-lipiodol mixture ablation

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	more than 3 years after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	until 3 months after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility	Technical success was defined as the ability to access and inject the mixture of ethanol/lipiodol into target tissue.	at the time of procedure

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Dankook University
• Investigators: Study Director: Do Hyun Park, MD, PhD, Asan Medical Center, Seoul, Korea, Republic of

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (ESTIMATE): July 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: neuroendocrine tumor; ethanol; endoscopic ultrasonography
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Antineoplastic Agents; Ethanol; Ethiodized Oil
• Other Study ID Numbers: NET ETHANOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO