This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric gastrointestinal stromal tumor. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric gastrointestinal stromal tumor. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.
Gastrointestinal stromal tumors (GIST) originate from interstitial cells of Cajal (ICC) and are the most common tumors derived from mesenchymal tissues of the digestive tract. GISTs can occur in any part of the digestive tract, among which gastric stromal tumors are the most common, accounting for about 60%. The incidence of GIST has been increasing in recent years, partly due to the gradual popularity of gastrointestinal endoscopy. Many early GISTs with smaller tumors have also received early diagnosis and treatment intervention. Due to the potential malignancy of GISTs, complete resection of the tumor is the first and only radical treatment option currently. Many studies have shown that laparoscopy is safe and effective approach in the treatment of gastric stromal tumors. In principle, as long as the tumor can be completely resected (neither residue macro nor microscopic) with intact tumor capsule and without tumor rupture, laparoscopic surgery is definite an option. Studies showed both short-term and long-term results of laparoscopic surgery were comparable to conventional open surgeries. On the other hand, endoscopic resection showed promising results in recent years. Endoscopic submucosal dissection endoscopic full-thickness resection are both reported with promising results in terms of safety and short-term efficacy. Though endoscopic resection has been suggested as one of the treatment options for gastric GISTs, No randomized controlled trial for endoscopic resection versus laparoscopic partial gastrectomy exists at this moment. This research is a prospective, multi-center trial for endoscopic resection and laparoscopic partial gastrectomy in patients with 2-5cm gastric GISTs. The primary purpose of this study is to evaluate the early operative morbidity and mortality and determine the safety of endoscopic resection compared with laparoscopic partial gastrectomy for 2-5cm gastric GISTs. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.
Study Type
INTERVENTIONAL
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
Early operative morbidity rate
The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications.
Time frame: 30 days
Early operative mortality rate
The early operative mortality is defined as deaths observed within 30 days following surgery.
Time frame: 30 days
Operation time
Operation time is documented as a composite outcome measure.
Time frame: intraoperative
Time to first ambulation
Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure.
Time frame: 30 days
Time to first flatus
Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure.
Time frame: 30 days
Time to first liquid diet
Time to first liquid diet is used to assess the postoperative recovery course, which is a composite outcome measure.
Time frame: 30 days
Time to first soft diet
Time to first soft diet is used to assess the postoperative recovery course, which is a composite outcome measure.
Time frame: 30 days
Postoperative hospital stay
The length of postoperative hospital stay will be recorded.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Time frame: 30 days
En bloc resection rate
The rate of en bloc resection in all cases will be recorded.
Time frame: 0, day of endoscopic surgery or laparoscopic surgery