- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07353346
Evaluation of Short-term and Long-term Efficacy of Endoscopic Treatment for Gastrointestinal Submucosal Tumors
This study aims to comprehensively assess how well endoscopic treatments work for gastrointestinal submucosal tumors (SMTs)-both in the short term right after treatment and over the long run-and to figure out what factors might affect the treatment's success. Specifically, it seeks to answer key questions: How effective are common endoscopic procedures at removing these tumors completely? What are the risks of complications like bleeding or perforation after treatment? Do patients stay healthy without the tumor coming back in the years following treatment? And what aspects (such as tumor size, location, or the type of endoscopic method used) influence whether the treatment works well or leads to problems? Study Description and Hypothesis Gastrointestinal submucosal tumors are growths that develop beneath the inner lining of the digestive tract (like the esophagus, stomach, or intestines). Unlike traditional open surgery, endoscopic treatments are minimally invasive-doctors use thin, flexible tubes with cameras and tools to remove tumors through natural body openings, which typically means smaller wounds, faster recovery, and no visible scars. However, there's still limited clear information about how well these treatments hold up over time or which patients benefit most.
This study is a retrospective analysis, meaning researchers will look back at the medical records of 700 patients who received endoscopic treatment for SMTs at Xijing Hospital between January 2012 and August 2025. The team will collect details like the tumor's size and location, the specific endoscopic method used (such as EMR, ESE, STER, or EFR), how long the procedure took, whether any complications occurred, and follow-up results to check for recurrence.
The study's core hypothesis is that endoscopic treatments are safe and effective for gastrointestinal submucosal tumors-successfully removing most tumors with low complication rates-and that factors like the tumor's size, where it's located in the digestive tract, and the type of endoscopic technique used will play a role in how well the treatment works and whether the tumor comes back later. By analyzing these past cases, the research hopes to provide reliable information to help doctors choose the best treatment for patients with SMTs in the future, ensuring more personalized and effective care.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who underwent endoscopic treatment for gastrointestinal submucosal tumors at Xijing Hospital from January 1, 2012 to August 1, 2025.
Exclusion Criteria:
- Patients with gastrointestinal protruding lesions caused by external compression.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical success rate
Time Frame: Three days after the operation
|
The surgical success rate is defined as the operation completion rate
|
Three days after the operation
|
|
long-term prognosis of patients
Time Frame: Taking 1 year, 3 years, and 5 years after surgery
|
long-term prognosis concerns the disease progression at 1 year, 3 years, and 5 years after surgery.
|
Taking 1 year, 3 years, and 5 years after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XJLL-KY-20252474
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastrointestinal Submucosal Tumors
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First Affiliated Hospital Xi'an Jiaotong UniversityAir Force Military Medical University, ChinaUnknown
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First Hospital of China Medical UniversityCompletedGastric Submucosal Tumors | Endoscopic Full Thickness Resection (EFTR)China
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Peking University People's HospitalEnrolling by invitationGastrointestinal Stromal Tumor (GIST) | Submucosal Tumor of Gastrointestinal TractChina
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Nanfang Hospital of Southern Medical UniversityUnknownLeiomyoma | Upper Gastrointestinal Submucosal Tumors (SMTs) | Gastrointestinal Stromal Tumors (GISTs)China
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Kliniken Ludwigsburg-Bietigheim gGmbHOvesco Endoscopy AGUnknownColorectal Adenomas | Submucosal TumorsGermany
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Qilu Hospital of Shandong UniversityQianfoshan Hospital; Shandong Second Provincial General HospitalNot yet recruitingEndoscopic Submucosal Dissection | Endoscopic Submucosal Dissection (ESD)
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Seoul National University HospitalTerminatedSubmucosal Tumor of Gastrointestinal TractKorea, Republic of
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Huazhong University of Science and TechnologyRecruitingLeiomyoma | Schwannoma | Gastrointestinal Stromal Tumor (GIST) | Submucosal TumorChina
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Huazhong University of Science and TechnologyZhongnan Hospital; Wuhan Central HospitalNot yet recruitingLeiomyoma | Gastrointestinal Stromal Tumor (GIST) | Submucosal TumorChina
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University of FloridaRecruitingEndoscopic Submucosal DissectionUnited States