RecruitingNCT03716089

Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site

Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site(FUGES-016)


Sponsor

Fujian Medical University

Enrollment

250 participants

Start Date

Oct 11, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

Participants with gastrointestinal stromal tumors(GIST) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of GIST and that of unfavorable site under the currently standard surgical therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing surgical outcomes between two groups of patients who have a type of stomach tumor called a gastrointestinal stromal tumor (GIST) removed using laparoscopic (keyhole) surgery — those whose tumor is in an easy-to-reach location versus those whose tumor is in a harder-to-reach location — to understand safety and effectiveness across both groups. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with a primary GIST of the stomach, confirmed by biopsy or imaging - Your tumor is 10 cm or smaller - Your general health is suitable for surgery (ECOG 0–1, ASA class I–III) - Your surgeon expects to achieve complete tumor removal by laparoscopy **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a severe mental disorder - You have had prior upper abdominal surgery (other than gallbladder removal) or prior gastric (stomach) surgery - You had a heart attack or stroke in the past 6 months - You have another active cancer in the past 5 years - Your surgery is an emergency (due to bleeding, obstruction, or perforation) - Your lung function is significantly reduced Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELaparoscopic resection

Laparoscopic surgery under general anesthesia


Locations(1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

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NCT03716089


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