A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

Detailed Description
-----------------
There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.

Official Title
-----------------
A Prospective, Multicenter Cohort Study on the Efficacy and Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Conditions
-----------------
Gastrointestinal Stromal Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years < age < 75 years Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology Patient informed consent and willingness to undergo laparoscopic resection Expected laparoscopic outcome of R0 resection Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of upper abdominal surgery (except the history of laparoscopic cholecystectomy) History of gastric surgery (except ESD/EMR for gastric cancer) History of other malignant diseases 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 other diseases Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| large group<br>laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors | |
| small group<br>laparoscopic resection of less than 5cm gastric gastrointestinal stromal tumors | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall postoperative morbidity | This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery. | 30 days after surgery or the first discharge ( if over 30 days hospital stay) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| Conversion to open surgery rate | Conversion to open surgery rate is defined as the rate of open surgery whatever the reason | 1 day | 
| Positive surgical margin rate | Positive surgical margin rate | 1 day | 
| The variation of white blood cell count | The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| The variation of hemoglobin | The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| The variation of C-reactive protein | The values of C-reactive protein in milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response | Preoperative 7 days and postoperative 1, 3, and 5 days | 
| overall postoperative serious morbidity rates | According to the Clavien-Dindo complication scoring system, grade IIIA and above is a serious complication, and when multiple complications occur at the same time, the complication with the highest grade will prevail. | 30 days after surgery or the first discharge ( if over 30 days hospital stay) | 
| Time to first ambulation | Time to first ambulation in days 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 | 
| 3-year overall survival rate | 3-year overall survival rate | 36 months | 
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months | 
| 3-year recurrence pattern | Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrectomy, Laparoscopic, gastrointestinal stromal tumor