Gastric Subepithelial TumorNCT05452265
Minimal Invasive Surgery for Gastric Subepithelial Tumor
An observational study of Gastric Subepithelial Tumor, run by Changhua Christian Hospital.
Trial summary
The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastric Subepithelial Tumor
- What is being tested?
- Endoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2021
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with gastric SETs who underwent ER or LR at the operative theater in our institution
Who may be able to join
- patients with gastric subepithelial tumors
- patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection
Who cannot join
- patients had gastric anatomic changes due to previous surgery
- patients converted open surgery
About this study
Official title: Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience
The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.
- Conditions
- Gastric Subepithelial Tumor
- Being tested
- Endoscopic resection
- Keywords
- gastric subepithelial tumors, endoscopic resection, laparoscopic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Also called Laparoscopic resection
Complete resection of gastric SETs was recommended if the tumor size was >2 cm, presence of malignant features, or if the patient was symptomatic, declined periodical surveillance, and preferred to undergo diagnostic and therapeutic resection.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic resection (ER) | ER with backup surgery was indicated for patients with endoscopic intent, and a small tumor size tolerated endoscopic retrieval. Receives: Procedure: Endoscopic resection | |
| laparoscopic resection (LR) | LR was indicated for patients with surgical intent, and those with the following conditions, which were not suitable for ER: (1) large tumor size with difficult endoscopic retrieval ; (2) symptoms of gastrointestinal tract bleeding with difficulty in endoscopic visualization; (3) suspicion of tumor rupture that required intra-abdominal exploration; and (4) histologic diagnosis of GIST with initial treatment of target therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
minutes of procedure time
Measured: during the procedure/surgery
Length of hospital stay
days of hospitalization
Measured: upto one month after surgery
Rate of postoperative major complications
complications required further intervention, clavien dindo classification upto Grade III
Measured: upto one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jan 2013
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Subepithelial TumorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452265
- Sponsor's protocol ID
- 220117
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Approach of Minimal Invasive Surgery for Gastric Subepithelial Tumor From A Single-Center Experience
- ClinicalTrials.gov ID
- NCT05452265
- Acronym / sponsor ID
- 220117
- Conditions
- Gastric Subepithelial Tumor
- Keywords
- gastric subepithelial tumors, endoscopic resection, laparoscopic resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Jul 2022 (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.
The investigators conducted a retrospective study of those patients with gastric SETs receiving ER or LR at the operative theater in the single institution from January 2013 to December 2021. Medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic resection (ER) | – | Procedure: Endoscopic resectionER with backup surgery was indicated for patients with endoscopic intent, and a small tumor size tolerated endoscopic retrieval. |
| laparoscopic resection (LR) | – | –LR was indicated for patients with surgical intent, and those with the following conditions, which were not suitable for ER: (1) large tumor size with difficult endoscopic retrieval ; (2) symptoms of gastrointestinal tract bleeding with difficulty in endoscopic visualization; (3) suspicion of tumor rupture that required intra-abdominal exploration; and (4) histologic diagnosis of GIST with initial treatment of target therapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with gastric SETs who underwent ER or LR at the operative theater in our institution
Key inclusion criteria (2 listed)
- patients with gastric subepithelial tumors
- patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection
Key exclusion criteria (2 listed)
- patients had gastric anatomic changes due to previous surgery
- patients converted open surgery
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 resectionAlso: Laparoscopic resectionComplete resection of gastric SETs was recommended if the tumor size was >2 cm, presence of malignant features, or if the patient was symptomatic, declined periodical surveillance, and preferred to undergo diagnostic and therapeutic resection. | Procedure or surgery | endoscopic resection (ER) |
Primary outcome
Procedure duration
Time frame: during the procedure/surgery
minutes of procedure time
Length of hospital stay
Time frame: upto one month after surgery
days of hospitalization
Rate of postoperative major complications
Time frame: upto one month after surgery
complications required further intervention, clavien dindo classification upto Grade III
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Subepithelial Tumor, run by Changhua Christian Hospital.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure duration (time frame: during the procedure/surgery). The study lists 3 primary outcomes in all. 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 11 Jul 2022.