Blinded Resection in Case of the Pancreatic Insulinoma

February 4, 2021 updated by: Ayrat Kaldarov, Vishnevsky Center of Surgery

Blinded Resection Avoided in Case of the Pancreatic Insulinoma

The blinded resection avoided in case of pancreatic insulinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients surgically treated in case of pancreatic insulinoma/proinsulinoma

Description

Inclusion Criteria:

The blinded resection of the insulinoma

Exclusion Criteria:

Other tumors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2010 June - 2020 June

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vishnevsky Center of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1899898189bf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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