search
Back to results

Laparoscopy to Remove Pancreatic Tumors (Insulinomas)

Primary Purpose

Insulinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative ultrasound
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Insulinoma focused on measuring Islet Cell Tumors, Surgery, Ultrasound, Insulin, Rapid Assay, Arteriogram, Pancreas, Laparoscopy, Insulinoma, Localization, Hypoglycemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 13, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT00005910
Brief Title
Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
Official Title
Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
This study will determine if laparoscopy can be used successfully to find and remove insulinomas (insulin-secreting tumors of the pancreas). These tumors are very small and often difficult to locate with magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound. Invasive procedures, such as arteriograms (X-ray imaging using a contrast agent injected into the bloodstream through a catheter) and venous sampling are more successful but involve more patient discomfort and greater risk. This study will test whether laparoscopy can be used to replace some or all of these tests, as well as more extensive surgery. Patients 11 years of age and older with low blood sugar (hypoglycemia) probably caused by an insulinoma may be eligible for this study. Candidates will have their hypoglycemia confirmed (with tests done under NIH protocol 91-DK-0066: Diagnosis and Treatment of Hypoglycemia) and will have CT imaging of the abdomen and MRI and ultrasound tests of the liver and pancreas. Patients whose tumors are not found by these studies will undergo arteriography of the pancreas and hepatic (liver) venous sampling. Patients will then have laparoscopy. This surgical procedure uses a laparoscope-a tube-like device with special cameras and an ultrasound probe attached through which the surgeon can see and operate inside the abdomen. Laparoscopy is commonly done to remove the gallbladder and is also used to remove portions of the pancreas. For the current procedure, the surgeon makes small incisions in the abdomen, inserts tubes, fills the abdomen with gas, and proceeds to explore and operate on the pancreas. The surgeon will try to locate the tumor with the laparoscope. If the tumor is found, the location will be verified by the imaging study results. If it cannot be located by laparoscopy, the results of the imaging studies will be disclosed to enable removal. If the tumor cannot be successfully removed using the laparoscope, standard surgery will then be performed. If the tumor cannot be found though laparoscopy, imaging studies, or traditional surgery, the operation will be concluded without removing any of the pancreas. Medical treatment will be initiated and re-evaluation will be recommended after 6 months.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma
Keywords
Islet Cell Tumors, Surgery, Ultrasound, Insulin, Rapid Assay, Arteriogram, Pancreas, Laparoscopy, Insulinoma, Localization, Hypoglycemia

7. Study Design

Study Phase
Not Applicable
Enrollment
23 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Intraoperative ultrasound

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8044542
Citation
Pedrazzoli S, Pasquali C, Alfano D'Andrea A. Surgical treatment of insulinoma. Br J Surg. 1994 May;81(5):672-6. doi: 10.1002/bjs.1800810513.
Results Reference
background
PubMed Identifier
224695
Citation
Wertkin MG, Dreiling DA. Surgical management of insulinoma. Am J Gastroenterol. 1979 Aug;72(2):146-52.
Results Reference
background
PubMed Identifier
3007832
Citation
Yamauchi H, Miyagawa K, Maeda M, Matsuno S, Sato T. Surgical management of insulinoma: diagnosis of tumor location and high incidence of malignancy. Jpn J Surg. 1986 Jan;16(1):8-15. doi: 10.1007/BF02471063.
Results Reference
background

Learn more about this trial

Laparoscopy to Remove Pancreatic Tumors (Insulinomas)

We'll reach out to this number within 24 hrs