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

NCT ID: NCT04344847

Last Updated: 2020-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-12

Study Completion Date

2020-06-12

Brief Summary

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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

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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

Conditions

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Excision Margin

Study Design

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Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type OTHER

Laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopic sleeve gastrectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All morbid obese patients with BMI more than 35

Exclusion Criteria

* previous gastric surgery
* patients with hiatus hernia
* age under 21 years
Minimum Eligible Age

21 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bassem Mohamed Sieda

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bassem Mohamed Sieda

Assistant professor of general surgery, faculty of medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Saudi german hospital

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Facility Contacts

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Bassem M Sieda

Role: primary

00966541900039 ext. 00966541900039

References

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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.

Reference Type RESULT
PMID: 30875013 (View on PubMed)

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.

Reference Type RESULT
PMID: 32221752 (View on PubMed)

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.

Reference Type RESULT
PMID: 30171396 (View on PubMed)

Other Identifiers

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0000-0002-9590

Identifier Type: -

Identifier Source: org_study_id

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