Insulinoma; PancreasNCT04741152
Blinded Resection in Case of the Pancreatic Insulinoma
An observational study of Insulinoma; Pancreas, run by Vishnevsky Center of Surgery.
Trial summary
The blinded resection avoided in case of pancreatic insulinoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insulinoma; Pancreas
- What is being tested?
- Pancreatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2020
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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
Study population: All patients surgically treated in case of pancreatic insulinoma/proinsulinoma
Who may be able to join
- The blinded resection of the insulinoma
Who cannot join
- Other tumors
About this study
Official title: Blinded Resection Avoided in Case of the Pancreatic Insulinoma
The blinded resection avoided in case of pancreatic insulinoma
Read the detailed description
Despite of the technique and technology developement there are still a lot of troubles to verify small benign-looking pancreatic NETs. It can be especially important in case of insulinoma. The organic hyperilsulinism and severe hypoglicemia causeb by the insulin/proinsulin - producing lesion can lead to severe complications and evem death.
There are some cases of the blinded resections of the pancreas in patients with the "hidden" insulinoma when the tumor can't be revealed during the preoperative diagnostics and intraoperatively. Unfortunately, blind resection do not solve the problem of the hypoglicemia but also cause the specific pancreatic complications.
- Conditions
- Insulinoma; Pancreas
- Being tested
- Pancreatic resection
- Keywords
- Insulinoma, Hypoglicemia, Blind resection, Hidden Insulinoma, ASVS
- Medical subject headings
- Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic resectionProcedure or surgery
Different pancreatic resections
| Study group | Role | What they receive |
|---|---|---|
| Revealed insulinoma | Cases when the tumor was revealed by the preoperative diagnostics and confirmed after the tumor elimination Receives: Procedure: Pancreatic resection | |
| Hidden Insulioma | Group when the insulinoma haven't been revealed preoperative and intraoperatively and the blind resection was performed. Receives: Procedure: Pancreatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
No hidden insulinomas
To improve the diagnostics of the tumor before and during the surgery. The "hidden" insulinomas haven't been diagnosed. The frozen section have to be routinely performed. The surgery haven't been finished before the morphologic confirmation of the resected lesion.
Measured: 2010 June - 2020 June
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study startJan 2010
- Primary completionJun 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulinoma; PancreasStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 197 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Vishnevsky Center of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayrat Kaldarov, Vishnevsky Center of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741152
- Sponsor's protocol ID
- 1899898189bf
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Resection Avoided in Case of the Pancreatic Insulinoma
- ClinicalTrials.gov ID
- NCT04741152
- Acronym / sponsor ID
- 1899898189bf
- Conditions
- Insulinoma; Pancreas
- Keywords
- Insulinoma, Hypoglicemia, Blind resection, Hidden Insulinoma, ASVS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Vishnevsky Center of SurgeryUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Feb 2021 (actual)
- 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.
The blinded resection avoided in case of pancreatic insulinoma
Detailed description
Despite of the technique and technology developement there are still a lot of troubles to verify small benign-looking pancreatic NETs. It can be especially important in case of insulinoma. The organic hyperilsulinism and severe hypoglicemia causeb by the insulin/proinsulin - producing lesion can lead to severe complications and evem death.
There are some cases of the blinded resections of the pancreas in patients with the "hidden" insulinoma when the tumor can't be revealed during the preoperative diagnostics and intraoperatively. Unfortunately, blind resection do not solve the problem of the hypoglicemia but also cause the specific pancreatic complications.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 10 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revealed insulinoma | – | Procedure: Pancreatic resectionCases when the tumor was revealed by the preoperative diagnostics and confirmed after the tumor elimination |
| Hidden Insulioma | – | Procedure: Pancreatic resectionGroup when the insulinoma haven't been revealed preoperative and intraoperatively and the blind resection was performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients surgically treated in case of pancreatic insulinoma/proinsulinoma
Key inclusion criteria (1 listed)
- The blinded resection of the insulinoma
Key exclusion criteria (1 listed)
- Other tumors
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 |
|---|---|---|
| Pancreatic resectionDifferent pancreatic resections | Procedure or surgery | Hidden Insulioma, Revealed insulinoma |
Primary outcome
No hidden insulinomas
Time frame: 2010 June - 2020 June
To improve the diagnostics of the tumor before and during the surgery. The "hidden" insulinomas haven't been diagnosed. The frozen section have to be routinely performed. The surgery haven't been finished before the morphologic confirmation of the resected lesion.
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 5 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulinoma; Pancreas, run by Vishnevsky Center of Surgery.
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 1 inclusion and 1 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
No hidden insulinomas (time frame: 2010 June - 2020 June). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2021.