Clinical Trial: EUS-guided Ethanol Ablation of an Insulinoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

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

Detailed Summary:

As the major insulinomas are functioning islet cell tumors, surgical resection is currently first-line therapy for or treatment of insulinomas. However, the surgical resection of pancreatic neoplasm is conditional for specific patients and may be associated with substantial life-threatening complications. Several studies declared that endoscopic ultrasound (EUS)-guided lavage may offer an alternative to surgical resection of insulinomas. Nevertheless, their sample sizes were small and conclusions were built based on short-term outcomes. In addition, the amount of ethanol administrated for different types of insulinomas were inconsistent among those studies.

The present study aims to evaluate the safety, feasibility and efficacy of EUS-guided ethanol ablation therapy of insulinomas. We will use cytopathology and immunohistochemistry in combination with EUS-FNA for diagnosis of insulinoma. After EUS-guided ethanol ablation therapy, the safety and efficacy will be assessed at the baseline and different time points during follow-up by physicians blinded to the treatment or control status.


Sponsor: Guangxi Medical University

Current Primary Outcome:

  • Efficacy of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ]
    Volumes of insulinomas before and after treatment, which are measured by cross-sectional imaging test (CT or MRS).
  • Safety of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ]
    Number of subjects with post-procedure adverse events


Original Primary Outcome: Same as current

Current Secondary Outcome: Technical feasibility [ Time Frame: during the procedure of treatment ]

Technical success was defined as ethanol is injected and lavaged into target tissue.


Original Secondary Outcome: Same as current

Information By: Guangxi Medical University

Dates:
Date Received: March 26, 2014
Date Started: March 2014
Date Completion: April 2018
Last Updated: April 22, 2014
Last Verified: April 2014