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

Recruiting

• Conditions: Gastrointestinal Stromal Tumors

• Registration Number: NCT05938309
• Lead Sponsor: Fujian Medical University

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-06-19
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-03
• Last Update Submitted: 2023-07-03
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2025-05-01
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Positive surgical margin rate	1 day	Positive surgical margin rate
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.
Time to first flatus	30 days	Time to first flatus 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.
Conversion to open surgery rate	1 day	Conversion to open surgery rate is defined as the rate of open surgery whatever the reason
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
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 ambulation	30 days	Time to first ambulation in days is used to assess the postoperative recovery course.
Time to first liquid diet	30 days	Time to first liquid 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.
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 soft diet	30 days	Time to first soft diet in days is used to assess the postoperative recovery course.
3-year disease free survival rate	36 months	3-year disease free survival rate
3-year overall survival rate	36 months	3-year overall survival rate

Trial Locations

Locations (1)

Department of Gastric Surgery， Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China