Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

April 13, 2020 updated by: Bassem Mohamed Sieda
LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

Study Type

Interventional

Enrollment (Anticipated)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

21 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All morbid obese patients with BMI more than 35

Exclusion Criteria:

  • previous gastric surgery
  • patients with hiatus hernia
  • age under 21 years

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

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: coincidental GIST during LSG patients
With institutional review board approval from Zagazig University Hospitals 338. A double-centre prospective study was conducted on prospectively collected data of all morbidly. 17 patients in Zagazig University Hospitals, Faculty of Medicine, Egypt and 321 patients done in bariatric surgery excellence unit in a tertiary hospital in Riyadh-KSA.
Procedure: Laparoscopic sleeve gastrectomy
Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excision of GIST during LSG
Time Frame: 4 years from start of study
we analyzed the incidence of GISTs in patients underwent LSG and investigated whether simultaneous resection can be oncologically adequate. as long as GIST is distal to staple line with a negative margin, laparoscopic sleeve gastrectomy can be done safely.
4 years from start of study

Collaborators and Investigators

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

Sponsor

Bassem Mohamed Sieda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 12, 2016

Primary Completion (Anticipated)

May 13, 2020

Study Completion (Anticipated)

June 12, 2020

Study Registration Dates

First Submitted

April 9, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 13, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0002-9590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES

IPD Sharing Time Frame

4 YEARS ,STARTING DECEMBER 2016

IPD Sharing Access Criteria

GIST during LSG

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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