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

Safety Clinical Trial

— EUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01902238
• Other study ID #: NET ETHANOL
• Status: Active, not recruiting
• Phase: N/A
• First received: July 15, 2013
• Last updated: November 29, 2016
• Start date: July 2013
• Est. completion date: August 2017

Study information

• Verified date: November 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoid Tumor
• Efficacy
• Feasibility
• Neuroendocrine Tumors
• Safety

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Dankook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	Yes