Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04344847
Other study ID # 0000-0002-9590
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04918381 - CellFX Treat & Resect Low-Risk BCC Feasibility Study N/A