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

NCT01902238 | Unknown DMC

• 1 other identifier: NET ETHANOL
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Efficacy; Safety; Feasibility

Keywords

neuroendocrine tumor; ethanol; endoscopic ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of participants with post-procedure adverse events

  until 3 months after procedure

Other Outcomes (1)

• Technical feasibility

  at the time of procedure

Study Arms (1)

EUS-guided ethanol-lipiodol mixture ablation

EXPERIMENTAL

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

Interventions

EUS-guided ethanol-lipiodol mixture ablation PROCEDURE

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.

EUS-guided ethanol-lipiodol mixture ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Dankook University: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Do Hyun Park, MD, PhD

  Asan Medical Center, Seoul, Korea, Republic of

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)