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Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas


N/A
N/A
N/A
Not Enrolling
Both
Insulinoma

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Trial Information

Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas


Patients with the clinical diagnosis of hypoglycemia secondary to a putative insulin
secreting pancreatic neuroendocrine tumor require accurate localization of the tumor and
definitive surgical resection. Non-invasive pre-operative imaging studies such as CT, MRI
and ultrasound often fail to accurately localize the lesion prior to surgery. Invasive
imaging such as arteriogram and selective arterial stimulation are a major improvement, but
may not be needed in all patients. This trial will evaluate the ability of laparoscopic
exploration with intraoperative ultrasound to localize the insulinoma and allow for its
resection with a single procedure.

Inclusion Criteria


INCLUSION CRITERIA:

Patients with a history of symptomatic hypoglycemia due to insulin or proinsulin secretion
presumed to be from an insulinoma.

Age greater than or equal to 11 years.

Patients must be willing to return to NIH for follow-up.

Patients (or their parents or guardians) must be able to sign informed consent.

EXCLUSION CRITERIA:

Patients with a history of Multiple Endocrine Neoplasia type 1 (MEN1) or Von-Hipple-Lindau
(VHL) syndrome or any history of a familial neuroendocrine tumor syndrome.

pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior
to enrollment.

Known allergy to contrast agents and contraindications to or failure of pretreatment with
prednisone, diphenhydramine, and cimetidine per standard procedure to prevent such
reactions.

Evidence of metastatic disease by CT, MRI or US.

Platelet count less than 50,000.

Medical condition which would preclude surgery including moderate to severe chronic lung
disease that may be worsened by gas insufflation of the abdomen.

Type of Study:

Interventional

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

000152

NCT ID:

NCT00005910

Start Date:

June 2000

Completion Date:

May 2006

Related Keywords:

  • Insulinoma
  • Islet Cell Tumors
  • Surgery
  • Ultrasound
  • Insulin
  • Rapid Assay
  • Arteriogram
  • Pancreas
  • Laparoscopy
  • Insulinoma
  • Localization
  • Hypoglycemia
  • Insulinoma

Name

Location

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Bethesda, Maryland  20892