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

Launched by FUJIAN MEDICAL UNIVERSITY · Oct 20, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a type of surgery called laparoscopic resection for patients with gastrointestinal stromal tumors (GISTs) in the stomach. The researchers are interested in comparing outcomes for tumors located in "favorable" sites (easier to access) versus "unfavorable" sites (more challenging to access). They want to find out how the surgery affects recovery and any complications that may arise afterwards.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a primary GIST confirmed by a biopsy. They should be in good overall health, able to undergo surgery, and have a tumor that is 10 cm or smaller. Participants can expect to have laparoscopic surgery, which is less invasive and often leads to quicker recovery times. The trial is currently recruiting, so if you or someone you know fits the criteria and is interested in learning more, it may be a good opportunity to consider.

Gender

ALL

Eligibility criteria

• 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