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Blinded Resection in Case of the Pancreatic Insulinoma

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ClinicalTrials.gov Identifier: NCT04741152
Recruitment Status : Completed
First Posted : February 5, 2021
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Ayrat Kaldarov, Vishnevsky Center of Surgery

Study Description
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Brief Summary:
The blinded resection avoided in case of pancreatic insulinoma

Condition or disease Intervention/treatment
Insulinoma; Pancreas Procedure: Pancreatic resection

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 197 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 10 Months
Official Title: Blinded Resection Avoided in Case of the Pancreatic Insulinoma
Actual Study Start Date : January 2010
Actual Primary Completion Date : June 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Revealed insulinoma
Cases when the tumor was revealed by the preoperative diagnostics and confirmed after the tumor elimination
 Procedure: Pancreatic resection
Different pancreatic resections
Hidden Insulioma
Group when the insulinoma haven't been revealed preoperative and intraoperatively and the blind resection was performed.
 Procedure: Pancreatic resection
Different pancreatic resections


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients surgically treated in case of pancreatic insulinoma/proinsulinoma
Criteria

Inclusion Criteria:

The blinded resection of the insulinoma

Exclusion Criteria:

Other tumors

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ayrat Kaldarov, Dr. Ayrat Kaldarov, Vishnevsky Center of Surgery
ClinicalTrials.gov Identifier: NCT04741152    
Other Study ID Numbers: 1899898189bf
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayrat Kaldarov, Vishnevsky Center of Surgery:
Insulinoma
Hypoglicemia
Blind resection
Hidden Insulinoma
ASVS
Additional relevant MeSH terms:
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Insulinoma
Adenoma, Islet Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases