- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04344847
Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11671
- Recruiting
- Saudi German Hospital
-
Contact:
- Bassem M Sieda
- Phone Number: 00966541900039 00966541900039
- Email: drbassemmostafa@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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
Sponsor
Publications and helpful links
General Publications
- Lyros O, Moulla Y, Mehdorn M, Schierle K, Sucher R, Dietrich A. Coincidental Detection of Gastrointestinal Stromal Tumors During Laparoscopic Bariatric Procedures-Data and Treatment Strategy of a German Reference Center. Obes Surg. 2019 Jun;29(6):1858-1866. doi: 10.1007/s11695-019-03782-y.
- Mazer L, Worth P, Visser B. Minimally invasive options for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2021 Mar;35(3):1324-1330. doi: 10.1007/s00464-020-07510-x. Epub 2020 Mar 27.
- Inaba CS, Dosch A, Koh CY, Sujatha-Bhaskar S, Pejcinovska M, Smith BR, Nguyen NT. Laparoscopic versus open resection of gastrointestinal stromal tumors: survival outcomes from the NCDB. Surg Endosc. 2019 Mar;33(3):923-932. doi: 10.1007/s00464-018-6393-8. Epub 2018 Aug 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-0002-9590
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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