Trial record 1 of 39 for:    "Insulinoma"
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EUS-guided Ethanol Ablation of an Insulinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanyu Qin, Guangxi Medical University
ClinicalTrials.gov Identifier:
NCT02121366
First received: March 26, 2014
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Insulinoma
Procedure: EUS-guided ethanol ablation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasound (EUS)-Guided Ethanol Ablation of an Insulinoma - A Multi-center Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by Guangxi Medical University:

Primary Outcome Measures:
  • Efficacy of EUS-guided ethanol ablation [ Time Frame: 1 to 12 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Number of subjects with post-procedure adverse events


Secondary Outcome Measures:
  • Technical feasibility [ Time Frame: during the procedure of treatment ] [ Designated as safety issue: Yes ]
    Technical success was defined as ethanol is injected and lavaged into target tissue.


Estimated Enrollment: 50
Study Start Date: March 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulinoma
Patients with Insulinomas will received EUS-guided ethanol ablation therapy
Procedure: EUS-guided ethanol ablation
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients whose condition is not suitable for the endoscopic procedure.
  2. Patients who have blood coagulation dysfunction.
  3. Patients who have mental disorders.
  4. Patients who have mild or severe cardiorespiratory insufficiency.
  5. Patients who have hypertension and could not be controlled to safe level.
  6. Pregnant and lactating women.
  7. Patients whose conditions are not suitable for the present study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02121366

Locations
China, Guangxi
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
Guangxi Medical University
Investigators
Study Chair: Shanyu Qin, MD. Ph.D. First Affiliated Hospital of Guangxi Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: Shanyu Qin, First Affiliated Hospital of Guangxi Medical University, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02121366     History of Changes
Other Study ID Numbers: EUS0511
Study First Received: March 26, 2014
Last Updated: April 22, 2014
Health Authority: China: Guangxi Medical University

Keywords provided by Guangxi Medical University:
Endoscopic Ultrasound-Guided Fine Needle Aspiration
Insulinoma
Ethanol
Ablation Techniques

Additional relevant MeSH terms:
Insulinoma
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
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 26, 2014