Gastrointestinal Stromal Tumors
Conditions
Keywords
Gastrectomy, Laparoscopic, gastrointestinal stromal tumor
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.
Interventions
None listed
Sponsors
Fujian Provincial Hospital
Fujian Cancer Hospital
First Affiliated Hospital of Fujian Medical University
900 Hospital of Joint Logistics Support Force of PLA
The First Affiliated Hospital of Xiamen University
The Second Affiliated Hospital of Fujian Medical University
The First Hospital of Putian City
The Affiliated Hospital(Group) of Putian University
Zhangzhou Municipal Hospital of Fujian Province
Longyan City First Hospital
Fujian Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years \< age \< 75 years 2. 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 3. Patient informed consent and willingness to undergo laparoscopic resection 4. Expected laparoscopic outcome of R0 resection 5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III
Exclusion criteria
1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy) 4. History of gastric surgery (except ESD/EMR for gastric cancer) 5. History of other malignant diseases within the past five years 6. History of unstable angina or myocardial infarction within the past six months 7. History of a cerebrovascular accident within the past six months 8. History of continuous systematic administration of corticosteroids within one month 9. Requirement of simultaneous surgery for other diseases 10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall postoperative morbidity | 30 days after surgery or the first discharge ( if over 30 days hospital stay) | This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion to open surgery rate | 1 day | Conversion to open surgery rate is defined as the rate of open surgery whatever the reason |
| Positive surgical margin rate | 1 day | Positive surgical margin rate |
| The variation of white blood cell count | Preoperative 7 days and postoperative 1, 3, and 5 days | 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. |
| The variation of hemoglobin | Preoperative 7 days and postoperative 1, 3, and 5 days | 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. |
| The variation of C-reactive protein | Preoperative 7 days and postoperative 1, 3, and 5 days | 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 |
| overall postoperative serious morbidity rates | 30 days after surgery or the first discharge ( if over 30 days hospital stay) | 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. |
| Time to first ambulation | 30 days | Time to first ambulation in days is used to assess the postoperative recovery course. |
| intraoperative morbidity rates | 1 day | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. |
| Time to first liquid diet | 30 days | Time to first liquid diet in days is used to assess the postoperative recovery course. |
| Time to first soft diet | 30 days | Time to first soft diet in days is used to assess the postoperative recovery course. |
| Duration of postoperative hospital stay | 30 days | Duration of postoperative hospital stay in days is used to assess the postoperative recovery course. |
| 3-year overall survival rate | 36 months | 3-year overall survival rate |
| 3-year disease free survival rate | 36 months | 3-year disease free survival rate |
| 3-year recurrence pattern | 36 months | Recurrence patterns are classified into four categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, and mixed type |
| Time to first flatus | 30 days | Time to first flatus in days is used to assess the postoperative recovery course. |
Countries
China
Contacts
Primary ContactPing Li, MD，PhD
Backup ContactLinghua Wei
Outcome results
None listed