NCT04741152

Brief Summary

The blinded resection avoided in case of pancreatic insulinoma

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

10.4 years

First QC Date

February 4, 2021

Last Update Submit

February 4, 2021

Conditions

Insulinoma; Pancreas

Keywords

InsulinomaHypoglicemiaBlind resectionHidden InsulinomaASVS

Outcome Measures

Primary Outcomes (1)

  • 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.

    2010 June - 2020 June

Study Arms (2)

Revealed insulinoma

Cases when the tumor was revealed by the preoperative diagnostics and confirmed after the tumor elimination

Procedure: Pancreatic resection

Hidden Insulioma

Group when the insulinoma haven't been revealed preoperative and intraoperatively and the blind resection was performed.

Procedure: Pancreatic resection

Interventions

Pancreatic resectionPROCEDURE

Different pancreatic resections

Hidden InsuliomaRevealed insulinoma

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients surgically treated in case of pancreatic insulinoma/proinsulinoma

You may qualify if:

  • The blinded resection of the insulinoma

You may not qualify if:

  • Other tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet CellAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ayrat Kaldarov

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 5, 2021

Study Start

January 1, 2010

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share