Gastric Soft Tissue Neoplasm Clinical Trial
Official title:
Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor
| Verified date | April 2018 |
| Source | First Affiliated Hospital Xi'an Jiaotong University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | December 20, 2018 |
| Est. primary completion date | December 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound); - The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ; - No evidence of tumor metastasis on all per-operative evaluations; Exclusion Criteria: - 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension; - 2. Patients with advanced malignant tumor; - 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor; - 4.Patients with ulcer penetration into tumors; - 5. Patients with the contraindications for general anesthesia; - 6. Patients were pregnant or younger than 18 years old; |
| Country | Name | City | State |
|---|---|---|---|
| China | the First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the rate of adverse events | Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage) | through study completion, an average of 6 months | |
| Secondary | rate of en bloc resection | the en bloc resection was defined as complete tumor resection with negative surgical margin. | 1 day | |
| Secondary | the rate of intact mucosal layer | intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation | 1 day | |
| Secondary | operation time | Operation time was defined from the time of docking to the time of trocar incision closure. | 1 day | |
| Secondary | estimated blood loss | Blood loss was estimated through the analysis of the surgical and anaesthesiological reports. | 1 day | |
| Secondary | time to oral diet | time to oral diet to assess the postoperative course. | 30 days | |
| Secondary | duration of postoperative hospital stay | From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course. | 30 days |