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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Surgery, GIST of Stomach, Gastric Cancer, Complication

Intervention / Treatment
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* Procedure: Laparoscopic resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Maximum tumor diameter ≤10cm Exclusion Criteria: 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) Rejection of laparoscopic resection History of other malignant disease within the past five years History of unstable angina or myocardial infarction within the past six months History of a cerebrovascular accident within the past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for another disease Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of the predicted values Maximum tumor diameter >10cm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (Study group)<br>Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group) | Procedure: Laparoscopic resection<br>* Laparoscopic surgery under general anesthesia<br>|
| Group B (Control group)<br>Group for laparoscopic resection of GIST with favorable group (favorable group) | Procedure: Laparoscopic resection<br>* Laparoscopic surgery under general anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | Definition of recurrence and recurrence date The following situations are regarded as recurrence 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. 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. 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. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative morbidity rates | . 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. . Intraoperative morbidity (occurring from skin incision to skin closure) including: surgery-related morbidity: intraoperative hemorrhage and injury: | 30 days | 
| Conversion to open surgery rate | . In this study, if the length of the auxiliary incision is more than 10 cm, it is considered a conversion to open surgery. .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. | 30 days | 
| Positive surgical margin rate | . The investigators confirm the surgical margin status by postoperative pathology report. . 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. | 30 days | 
| Overall postoperative serious complications rates | . 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. . 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. | 30 days | 
| 3-year overall survival rate | The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first. For survival cases, the end point is the last date that survival was confirmed. If loss to follow-up occurred, the end point is the final date that survival could be confirmed. | 36 months | 
| 3-year recurrence pattern | Definition of recurrence and recurrence date The following situations are regarded as recurrence 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. 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. 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. A rise in carcinoembryonic antigen or other associated tumor markers alone could not be diagnosed as a relapse. | 36 months | 
| Overall postoperative morbidity and mortality rates | The number of all patients treated with surgery as the denominator and the number of the patients with any intraoperative and postoperative morbidity and mortality as the numerator are used to calculate the proportions. Postoperative morbidities are divided into short-term and long-term complications after surgery. Short-term is defined as within 30 days of surgery or the first discharge if the hospital stay is > 30 days. 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. Postoperative mortality: patients whose death was identified according to documented intraoperative observation items, including patients who die within 30 days after surgery (including the 30th day) regardless of the causality between death and surgery, and patients who die more than 30 days after surgery. | 30 days | 
| Time to first ambulation | Time to first ambulation in hours is used to assess the postoperative recovery course. | 30 days | 
| Time to first flatus | Time to first flatus in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first liquid diet | Time to first liquid diet in days is used to assess the postoperative recovery course. | 30 days | 
| Time to first soft diet | Time to first soft diet in days is used to assess the postoperative recovery course. | 30 days | 
| Duration of postoperative hospital stay | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. | 30 days | 
| Intraoperative tumor rupture rates | Intraoperative tumor rupture rates are used to access the oncological safety of the intervention. | 1 day | 
| The variation of album | The variation of album in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life. | Preoperative 7 days and postoperative 1 and 5 days | 
| The variation of hemoglobin | The variation of hemoglobin in gram/liter on preoperative 7 days and postoperative 1 and 5 days are used to access the postoperative nutritional status and quality of life. | Preoperative 7 days and postoperative 1 and 5 days | 
| The variation of white blood cell count | The values of white blood cell count from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1 and 5 days | 
| The variation of C-reactive protein | The values of C-reactive protein IN milligram/liter from peripheral blood preoperative 7 days and postoperative 1 and 5 days are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1 and 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIST, laparoscopic resection, early complication, mortality, tumor sites