Excision MarginNCT04344847
Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin
A study testing Laparoscopic sleeve gastrectomy in people with Excision Margin, run by Bassem Mohamed Sieda at 1 site in Saudi Arabia.
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 Read more about this study
- Who is it for?
- Ages 21 to 42 years
- Conditions the study is for
- Excision Margin
- What is being tested?
- Laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Dec 2016to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All morbid obese patients with BMI more than 35
Who cannot join
- previous gastric surgery
- patients with hiatus hernia
- age under 21 years
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Saudi german hospital
Riyadh, 11671
Bassem M Sieda, 00966541900039 ext. 00966541900039, drbassemmostafa@yahoo.com
About this study
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
Read the 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
- Conditions
- Excision Margin
- Being tested
- Laparoscopic sleeve gastrectomy
- Keywords
- Gastrointestinal stromal tumour, Coincidental GIST with LSG, Gastric GIST
- Medical subject headings
- Margins of Excision, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start12 Dec 2016
- Primary completion13 May 2020 (estimated)
- Study completion12 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Excision MarginStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Sequential
- 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)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bassem Mohamed Sieda
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bassem Mohamed Sieda, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344847
- Sponsor's protocol ID
- 0000-0002-9590
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES
Publications
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.
PubMed 30875013Mazer 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.
PubMed 32221752Inaba 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.
PubMed 30171396
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin
- ClinicalTrials.gov ID
- NCT04344847
- Acronym / sponsor ID
- 0000-0002-9590
- Conditions
- Excision Margin
- Keywords
- Gastrointestinal stromal tumour, Coincidental GIST with LSG, Gastric GIST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Bassem Mohamed SiedaOther government
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 13 May 2020 (estimated)
- Study completion
- 12 Jun 2020 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| coincidental GIST during LSG patients | Other | Procedure: Laparoscopic sleeve gastrectomyWith 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. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All morbid obese patients with BMI more than 35
Key exclusion criteria (3 listed)
- previous gastric surgery
- patients with hiatus hernia
- age under 21 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic sleeve gastrectomyExcision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm | Procedure or surgery | coincidental GIST during LSG patients |
Primary outcome
Excision of GIST during LSG
Time frame: 4 years from start of study
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Results publication: PubMed 30875013Lyros 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 publication: PubMed 32221752Mazer 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 publication: PubMed 30171396Inaba 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.
- Individual participant dataSharing planned: Yes. WHEN REGISTERED AND APPROVED FOR PUBLICATION, I WILL SHARE THROUGH ALL SCIENTIFIC SITES
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy in people with Excision Margin, run by Bassem Mohamed Sieda at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excision of GIST during LSG (time frame: 4 years from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04344847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.