EUS-guided Ethanol Ablation of an Insulinoma

NCT02121366 | Unknown DMC

• 1 other identifier: EUS0511
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate the feasibility, safety and efficacy of EUS-guided ethanol ablation of an insulinoma.

Conditions

Insulinoma

Keywords

Endoscopic Ultrasound-Guided Fine Needle Aspiration; Insulinoma; Ethanol; Ablation Techniques

Outcome Measures

Primary Outcomes (2)

• Efficacy of EUS-guided ethanol ablation

  Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).

  1 to 12 month

• Safety of EUS-guided ethanol ablation

  Number of subjects with post-procedure adverse events

  1 to 12 month

Secondary Outcomes (1)

• Technical feasibility

  during the procedure of treatment

Study Arms (1)

Insulinoma

EXPERIMENTAL

Patients with Insulinomas will received EUS-guided ethanol ablation therapy

Procedure: EUS-guided ethanol ablation

Interventions

EUS-guided ethanol ablation PROCEDURE

Diagnostic evaluation for suspected insulinoma is performed by cytology or immunohistochemistry. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol under the guidance of EUS was injected into the lesion. The amount of ethanol is administrated according to the size of lesion.

Insulinoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults: at least 18 years.
• Patients with insulinomas which are evaluated by histopathology .
• patients who have signed a written consent form.

You may not qualify if:

• Patients whose condition is not suitable for the endoscopic procedure.
• Patients who have blood coagulation dysfunction.
• Patients who have mental disorders.
• Patients who have mild or severe cardiorespiratory insufficiency.
• Patients who have hypertension and could not be controlled to safe level.
• Pregnant and lactating women.
• Patients whose conditions are not suitable for the present study.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Shanyu Qin, MD. Ph.D.

  First Affiliated Hospital of Guangxi Medical University

  STUDY CHAIR

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: First Affiliated Hospital of Guangxi Medical University

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 23, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2018
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

CN (1)