Clinical trial NCT04751591: Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric GIST
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Early operative morbidity rate
timeFrame: 30 days
measure: Early operative mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Operation time
timeFrame: intraoperative
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Postoperative hospital stay
timeFrame: 30 days
measure: En bloc resection rate
timeFrame: 0, day of endoscopic surgery or laparoscopic surgery
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: Pinghong Zhou
role: PRINCIPAL_INVESTIGATOR
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