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

Excision Margin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344847
• Other study ID #: 0000-0002-9590
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: June 12, 2020

Study information

• Verified date: April 2020
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: June 12, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 42 Years

Eligibility

Inclusion Criteria:

All morbid obese patients with BMI more than 35

Exclusion Criteria:

• previous gastric surgery

• patients with hiatus hernia

• age under 21 years

Related Conditions & MeSH terms

• Excision Margin
• Gastrointestinal Stromal Tumors

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm

Locations

Country	Name	City	State
Saudi Arabia	Saudi german hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Bassem Mohamed Sieda

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

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. — View 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):1858-186 — View Citation

Mazer L, Worth P, Visser B. Minimally invasive options for gastrointestinal stromal tumors of the stomach. Surg Endosc. 2020 Mar 27. doi: 10.1007/s00464-020-07510-x. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years from start of study