Status:
UNKNOWN
Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Gastric GIST
Eligibility:
All Genders
18-80 years
Phase:
NA
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 t...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04751591
Start Date
December 15 2021
End Date
June 30 2024
Last Update
November 30 2021
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