Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005910
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-06-13
Brief Title:
Laparoscopy to Remove Pancreatic Tumors Insulinomas
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-DK-0152 | None | None | None |