About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years old
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
Written informed consent
Expected R0 resection by laparoscopy
Disqualifiers
Pregnant and lactating women
Suffering from a severe mental disorder
History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
History of previous gastric surgery (including ESD/EMR for gastric cancer)
Trial population
All patients who meet the inclusion criteria and not conform to the exclusion criteria are qualified for this study.
Trial design
Case-control
Prospective
Treatments tested in this trial
Laparoscopic resection
Procedure/SurgeryLaparoscopic surgery under general anesthesia
Treatment groups
Trial outcomes
Primary outcomes
3-year disease free survival rate
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.
Secondary outcomes
Intraoperative morbidity rates
1. . The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative morbidity as the numerator are used to calculate the proportions. 2. . Intraoperative morbidity (occurring from skin incision to skin closure) including: surgery-related morbidity: intraoperative hemorrhage and injury:
Conversion to open surgery rate
1. . In this study, if the length of the auxiliary incision is more than 10 cm, it is considered a conversion to open surgery. 2. .The number of all patients treated with surgery as the denominator and the number of the patients with conversion to open surgery as the numerator are used to calculate the proportions.
Positive surgical margin rate
1. . The investigators confirm the surgical margin status by postoperative pathology report. 2. . The number of all patients treated with surgery as the denominator and the number of the patients with positive surgical margin as the numerator are used to calculate the proportions.
Overall postoperative serious complications rates
1. . Incidence of postoperative major complications: The standard for postoperative major complications refers to the short-term complications according to the Clavien-dindo grade, IIIA level and above for serious complications, and when multiple complications occur simultaneously, the highest ranked complication is the subject. 2. . Postoperative complications are divided into short-term complications after surgery and long-term complications after surgery. (3)Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is \> 30 days. (4)Long-term is defined as the period from 30 days or more after the operation or the period between first discharge (the hospital days after surgery \>30 days) and 3 years after the operation.
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