Laparoscopic resection: Laparoscopic surgery under general anesthesia
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age between 18 and 75 years old
2. Primary gastric lesion confirmed pathologically GIST by endoscopic biopsy. Preoperative endoscopy, ultrasound endoscopy or computer tomography, Magnetic resonance suspected GIST, and then postoperative pathology confirmed as the original GIST
3. Written informed consent
4. Expected R0 resection by laparoscopy
5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Maximum tumor diameter ≤10cm
Exclusion Criteria:
1. Pregnant and lactating women
2. Suffering from a severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of other malignant disease within the past five years
7. History of unstable angina or myocardial infarction within the past six months
8. History of a cerebrovascular accident within the past six months
9. History of continuous systematic administration of corticosteroids within one month
10. Requirement of simultaneous surgery for another disease
11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1\<50% of the predicted values
13. Maximum tumor diameter \>10cm
Primary outcome measure(s)
3-year disease free survival rate — 36 months Definition of recurrence and recurrence date The following situations are regarded as "recurrence"
1. Recurrence identified by any one image examination (X-ray, ultrasound, computed tomography, magnetic resonance imaging, etc.) and, if there are a variety of imaging examinations, results without contradiction determined "recurrence". The earliest date that the recurrence is found is defined as the "recurrence date".
2. For cases that lack the use of imaging or a pathological diagnosis, the date of diagnosing the occurrence of clinical recurrence based on clinical history and physical examination is defined as the "recurrence date".
3. For cases without imaging or clinical diagnosis but with a cytology or tissue biopsy pathological diagnosis of recurrence, the earliest date confirmed by cytology or biopsy pathology is considered the "recurrence date".
4. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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