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NCT00005910 · ClinicalTrials.gov registry record · NA
Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
A NA study of Insulinoma, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00005910: Completed NA study of Insulinoma, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00005910 is a NA study of Insulinoma that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 23 participants, below the 417-participant average among 5 other Insulinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005910, a NA study of Insulinoma, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE Intraoperative ultrasound
Study Locations (1)
Maryland
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2000-06 |
| Est. Completion | 2006-05 |
| Phase | NA |
What the finished NCT00005910 record still lists
NCT00005910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 417-participant average among 5 other Insulinoma trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Insulinoma appearing as the primary indexed condition, and to 1 intervention - of which Intraoperative ultrasound is the first listed.
NCT00005910 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00005910 about?
NCT00005910 is a clinical study titled "Laparoscopy to Remove Pancreatic Tumors (Insulinomas)". 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, s...
What is the current status of trial NCT00005910?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2000-06. Estimated completion is 2006-05.
What conditions does trial NCT00005910 study?
This clinical trial studies the following conditions: Insulinoma.
What interventions are being tested in trial NCT00005910?
The interventions under investigation include: Intraoperative ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT00005910?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005910 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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