Clinical trial NCT03804762: A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)
Official title: Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Soft Tissue Neoplasm
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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；

Primary outcomes:
measure: the rate of adverse events
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: rate of en bloc resection
timeFrame: 1 day
measure: the rate of intact mucosal layer
timeFrame: 1 day
measure: operation time
timeFrame: 1 day
measure: estimated blood loss
timeFrame: 1 day
measure: time to oral diet
timeFrame: 30 days
measure: duration of postoperative hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: the First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Junjun She, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shi F, Li Y, Pan Y, Sun Q, Wang G, Yu T, Shi C, Li Y, Xia H, She J. Clinical feasibility and safety of third space robotic and endoscopic cooperative surgery for gastric gastrointestinal stromal tumors dissection : A new surgical technique for treating gastric GISTs. Surg Endosc. 2019 Dec;33(12):4192-4200. doi: 10.1007/s00464-019-07223-w. Epub 2019 Oct 17.