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Clinical Trials/NCT04344847
NCT04344847
Unknown
Not Applicable

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

Bassem Mohamed Sieda1 site in 1 country338 target enrollmentDecember 12, 2016
ConditionsExcision Margin

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Excision Margin
Sponsor
Bassem Mohamed Sieda
Enrollment
338
Locations
1
Primary Endpoint
Excision of GIST during LSG
Last Updated
6 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
December 12, 2016
End Date
June 12, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Bassem Mohamed Sieda
Responsible Party
Sponsor Investigator
Principal Investigator

Bassem Mohamed Sieda

Assistant professor of general surgery, faculty of medicine

Zagazig University

Eligibility Criteria

Inclusion Criteria

  • All morbid obese patients with BMI more than 35

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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