InsulinomaNCT00005910
Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
A study testing Intraoperative ultrasound in people with Insulinoma, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insulinoma
- What is being tested?
- Intraoperative ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
About this study
Official title: Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas
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.
Read the 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.
- Conditions
- Insulinoma
- Being tested
- Intraoperative ultrasound
- Keywords
- Islet Cell Tumors, Surgery, Ultrasound, Insulin, Rapid Assay, Arteriogram, Pancreas, Laparoscopy, Insulinoma, Localization, Hypoglycemia
- Medical subject headings
- Insulinoma, Adenoma, Islet Cell, Insulin Resistance, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasoundProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2000 (estimated)
- Study startJun 2000
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsulinomaStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Enrolment
- 23 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005910
- Sponsor's protocol ID
- 000152
- Other IDs
- 00-DK-0152
- Status last verified
- May 2006
- First submitted
- 13 Jun 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 8044542Wertkin MG, Dreiling DA. Surgical management of insulinoma. Am J Gastroenterol. 1979 Aug;72(2):146-52.
PubMed 224695Yamauchi 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.
PubMed 3007832
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Laparoscopy for Localization and Resection of Insulinomas of the Pancreas
- ClinicalTrials.gov ID
- NCT00005910
- Acronym / sponsor ID
- 000152
- Conditions
- Insulinoma
- Keywords
- Islet Cell Tumors, Surgery, Ultrasound, Insulin, Rapid Assay, Arteriogram, Pancreas, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- May 2006
- First posted
- 14 Jun 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ultrasound | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8044542Pedrazzoli 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.
- Background: PubMed 224695Wertkin MG, Dreiling DA. Surgical management of insulinoma. Am J Gastroenterol. 1979 Aug;72(2):146-52.
- Background: PubMed 3007832Yamauchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ultrasound in people with Insulinoma, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.