Study On Safety Of Endoscopic Resection For 2-5cm Gastric Gastrointestinal Stromal Tumor
NCT ID: NCT04751591
Last Updated: 2021-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
260 participants
INTERVENTIONAL
2021-12-15
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic resection
The endoscopist will perform endoscopic resection for patients enrolled in this group.
Endoscopic resection
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
Laparoscopic partial gastrectomy
The endoscopist will perform laparoscopic partial gastrectomy for patients enrolled in this group.
Laparoscopic partial gastrectomy
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
Interventions
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Endoscopic resection
Endoscopic submucosal dissection (ESD) or endoscopic full-thickness resection (EFTR) for patients with 2-5cm gastric GISTs
Laparoscopic partial gastrectomy
Laparoscopic partial gastrectomy for patients with 2-5cm gastric GISTs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Pinghong Zhou
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Central Contacts
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References
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Other Identifiers
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SK2020-032
Identifier Type: -
Identifier Source: org_study_id