Clinical trial NCT03716089: Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site
Official title: Prospective Controlled Clinical Trial for Comparison of Tumor Efficacy Safety in Laparoscopic Resection of Gastrointestinal Stromal Tumors Between Favorable and Unfavorable Site（FUGES-016）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: GIST of Stomach
Gastric Cancer
Surgery
Complication
Keywords: GIST
laparoscopic resection
early complication
mortality
tumor sites
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.

Brief 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.

Detailed description: 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. Main end of study: 3-year disease free survival rate

Eligibility criteria: 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 outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Intraoperative morbidity rates
timeFrame: 30 days
measure: Conversion to open surgery rate
timeFrame: 30 days
measure: Positive surgical margin rate
timeFrame: 30 days
measure: Overall postoperative serious complications rates
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Overall postoperative morbidity and mortality rates
timeFrame: 30 days
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: Intraoperative tumor rupture rates
timeFrame: 1 day
measure: The variation of album
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
measure: The variation of white blood cell count
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 7 days and postoperative 1 and 5 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References:
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