Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Safety Between Endoscopic Resection And Laparoscopic Partial Gastrectomy In Patients With 2-5cm Gastric Gastrointestinal Stromal Tumor

Conditions
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Gastric GIST

Intervention / Treatment
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* Procedure: Endoscopic resection
* Procedure: Laparoscopic partial gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with gastric GISTs in imaging examinations including contrast-enhanced abdominal and pelvic CT, EGD examination and endoscopic ultrasound examination The maximum diameter of the tumor is > 2cm and ≤ 5cm No history of upper abdominal surgery (except for laparoscopic cholecystectomy) No history of neoadjuvant therapy or targeted therapy Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1 Preoperative ASA (American Society of Anesthesiologists) scoring: I-III Sufficient organ functions Written informed consent Exclusion Criteria: Gastric GISTs with completely extra-luminal growth pattern Metastases found in preopreative examinations History of simultaneous malignancies or heterochronous malignancies within 5 years Women during pregnancy or breast-feeding Severe heart and lung disease, severe renal insufficiency, unable to perform laparoscopic surgery Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated Severe mental disease Severe respiratory disease Severe hepatic and renal dysfunction Unstable angina pectoris or history of myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months Patients with other diseases who can be surgically intervened at the same time Continuous systemic steroid therapy within 1 month (except for topical use) Patients are participating or have participated in another clinical trial (within 6 months)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic resection<br>The endoscopist will perform endoscopic resection for patients enrolled in this group. | Procedure: Endoscopic resection<br>* Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs<br>|
| Other: Laparoscopic partial gastrectomy<br>The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group. | Procedure: Laparoscopic partial gastrectomy<br>* Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early operative morbidity rate | The early operative morbidity is defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications. | 30 days | 
| Early operative mortality rate | The early operative mortality is defined as deaths observed within 30 days following surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time is documented as a composite outcome measure. | intraoperative | 
| Time to first ambulation | Time to first ambulation is used to assess the postoperative recovery course, which is a composite outcome measure. | 30 days | 
| Time to first flatus | Time to first flatus is used to assess the postoperative recovery course, which is a composite outcome measure. | 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. | 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. | 30 days | 
| Postoperative hospital stay | The length of postoperative hospital stay will be recorded. | 30 days | 
| En bloc resection rate | The rate of en bloc resection in all cases will be recorded. | 0, day of endoscopic surgery or laparoscopic surgery |