NCT04344847

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3.4 years

First QC Date

April 9, 2020

Last Update Submit

April 13, 2020

Conditions

Excision Margin

Keywords

Gastrointestinal stromal tumourCoincidental GIST with LSGGastric GIST

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

coincidental GIST during LSG patients

OTHER

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.

Procedure: Laparoscopic sleeve gastrectomy

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

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

coincidental GIST during LSG patients

Eligibility Criteria

Age21 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All morbid obese patients with BMI more than 35

You may not qualify if:

  • previous gastric surgery
  • patients with hiatus hernia
  • age under 21 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saudi german hospital

Riyadh, 11671, Saudi Arabia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 30875013RESULT

  • 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.

    PMID: 32221752RESULT

  • 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.

    PMID: 30171396RESULT

MeSH Terms

Conditions

Margins of ExcisionGastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Morphological and Microscopic FindingsPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor of general surgery, faculty of medicine

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 14, 2020

Study Start

December 12, 2016

Primary Completion

May 13, 2020

Study Completion

June 12, 2020

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
4 YEARS ,STARTING DECEMBER 2016
Access Criteria
GIST during LSG

Locations

SA(1)