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

Not Applicable

• Conditions: Excision Margin
• Interventions: Procedure: Laparoscopic sleeve gastrectomy

• Registration Number: NCT04344847
• Lead Sponsor: Bassem Mohamed Sieda

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

Study Timeline

• Study Start: 2016-12-12
• Status Verified: 2020-04
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-13
• Last Update Submitted: 2020-04-13
• Study First Posted: 2020-04-14
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-05-13
• Study Completion: 2020-06-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 338

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
coincidental GIST during LSG patients	Laparoscopic sleeve gastrectomy	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.

Primary Outcome Measures

Name	Time	Method
Excision of GIST during LSG	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.

Trial Locations

Locations (1)

Saudi german hospital; 🇸🇦 Riyadh, Saudi Arabia