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

Fujian Medical University

Status: Enrolling

Conditions: Complication; Gastric Cancer; Surgery; GIST of Stomach

Treatments: Procedure: Laparoscopic resection

Study type: Observational

Funder types: Other

Identifiers

NCT03716089

FUGES-016

Details and patient eligibility

About

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.

Full description

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

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 75 years old
2. 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
3. Written informed consent
4. Expected R0 resection by laparoscopy
5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Maximum tumor diameter ≤10cm

Exclusion criteria

1. Pregnant and lactating women
2. Suffering from a severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of other malignant disease within the past five years
7. History of unstable angina or myocardial infarction within the past six months
8. History of a cerebrovascular accident within the past six months
9. History of continuous systematic administration of corticosteroids within one month
10. Requirement of simultaneous surgery for another disease
11. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
12. FEV1<50% of the predicted values
13. Maximum tumor diameter >10cm

Trial design

250 participants in 2 patient groups

Group A (Study group)

Description:

Group for laparoscopic resection of GIST with unfavorable group (Unfavorable group)

Treatment:

Procedure: Laparoscopic resection

Group B (Control group)

Description:

Group for laparoscopic resection of GIST with favorable group (favorable group)

Treatment:

Procedure: Laparoscopic resection