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

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Laparoscopic sleeve gastrectomy

About this trial

This is an interventional treatment trial for Excision Margin focused on measuring Gastrointestinal stromal tumour, Coincidental GIST with LSG, Gastric GIST

Eligibility Criteria

21 Years - 42 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All morbid obese patients with BMI more than 35

Exclusion Criteria:

previous gastric surgery
patients with hiatus hernia
age under 21 years

Sites / Locations

Saudi german hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

coincidental GIST during LSG patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Excision of GIST during LSG

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04344847

First Posted

April 9, 2020

Last Updated

April 13, 2020

Sponsor

Bassem Mohamed Sieda

1. Study Identification

Unique Protocol Identification Number

NCT04344847

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 12, 2016 (Actual)

Primary Completion Date

May 13, 2020 (Anticipated)

Study Completion Date

June 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bassem Mohamed Sieda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Excision Margin

Keywords

Gastrointestinal stromal tumour, Coincidental GIST with LSG, Gastric GIST

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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.

Masking

None (Open Label)

Masking Description

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.

Enrollment

338 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

coincidental GIST during LSG patients

Arm Type

Other

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic sleeve gastrectomy

Intervention Description

Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm

Primary Outcome Measure Information:

Title

Excision of GIST during LSG

Description

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.

Time Frame

4 years from start of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

No

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

Facility Information:

Facility Name

Saudi german hospital

City

Riyadh

ZIP/Postal Code

11671

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bassem M Sieda

Phone

00966541900039

Ext

00966541900039

Email

drbassemmostafa@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

30875013

Citation

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.

Results Reference

result

PubMed Identifier

32221752

Citation

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.

Results Reference

result

PubMed Identifier

30171396

Citation

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.

Results Reference

result

Excision Margin

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial