Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal TumorCELSGISTNCT03471273
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
A study testing endoscopic management, surgery and follow up in people with Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
- What is being tested?
- endoscopic management, surgery and follow up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2017to 31 Dec 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old Chinese;
- Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
- Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
Who cannot join
- Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
- Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
- gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
- The investigator considers that it is not suitable for this test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospistal
Guangzhou, Guangdong, 510515
Fang Xie, Doctor, 15692428926, stellaff@126.com
About this study
Official title: Comparison of Endoscopic and Laparoscopic Resection for Small Gastric
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
- Being tested
- endoscopic management, surgery and follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic management, surgery and follow upProcedure or surgery
endoscopic management, surgery and follow up
| Study group | Role | What they receive |
|---|---|---|
| endoscopic management | Other | Not described Receives: Procedure: endoscopic management, surgery and follow up |
| follow up | Other | Not described Receives: Procedure: endoscopic management, surgery and follow up |
| surgery | Other | Not described Receives: Procedure: endoscopic management, surgery and follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
recur or not in 2 years after endoscopic surgical procedure or surgery
Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.
Measured: 2 years after endoscopic surgical procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start18 Sep 2017
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471273
- Sponsor's protocol ID
- LC2016ZD013
- Acronym
- CELSGIST
- Status last verified
- Jan 2018
- First submitted
- 19 Jan 2018
- Last updated
- 20 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic and Laparoscopic Resection for Small Gastric
- ClinicalTrials.gov ID
- NCT03471273
- Acronym / sponsor ID
- CELSGIST / LC2016ZD013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Hospital of Southern Medical University
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Mar 2018 (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.
Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| endoscopic management | Other | Procedure: endoscopic management, surgery and follow up |
| follow up | Other | Procedure: endoscopic management, surgery and follow up |
| surgery | Other | Procedure: endoscopic management, surgery and follow up |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years old Chinese;
- Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;
- Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.
Key exclusion criteria (4 listed)
- Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;
- Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;
- gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;
- The investigator considers that it is not suitable for this test.
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 |
|---|---|---|
| endoscopic management, surgery and follow upendoscopic management, surgery and follow up | Procedure or surgery | endoscopic management, follow up, surgery |
Primary outcome
recur or not in 2 years after endoscopic surgical procedure or surgery
Time frame: 2 years after endoscopic surgical procedure or surgery
Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: Undecided
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 endoscopic management, surgery and follow up in people with Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 3 inclusion and 4 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 20 Mar 2018. 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 China. 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?
Contact Lan Bai, Doctor (15692428926, stellaff@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recur or not in 2 years after endoscopic surgical procedure or surgery (time frame: 2 years after endoscopic surgical procedure or surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.