Clinical trial NCT03612830: A Randomized Controlled Clinical Study on the Application of the Third Space in the Operation of Gastric Submucosal Tumor
Official title: Comparison of Laparoscopic and Endoscopic Cooperative Surgery and Robotic and Endoscopic Cooperative Surgery in the Operation of Gastric Submucosal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Submucosal Tumors
Keywords: The Third Space
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2018-08-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Laparoscopic and Endoscopic cooperative sugery,Robotic and Endoscopic cooperative sugery
Primary purpose: TREATMENT

Brief summary: Gastric submucosal tumors (SMTs) are rare findings during routine upper endoscopy; the incidence of these lesions may be as high as 0.4%.SMTs display a wide spectrum,ranging from benign to highly malignant, with gastrointestinal stromal tumors (GISTs) being the most common type.SMTs is a gastrointestinal tumor,surgical operation is still the main method of gastric tumor treatment.The common surgical methods for resection of SMTs include laparotomy and laparoscopic surgery.In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect.In recent years, some scholars have put forward the concept of the third space.The concept of the "third space" was initiatively proposed at the same time when new endoscopic surgery approach via natural orifice transluminal was put forward(NOTES). To be specific, with respect to the first space(lumen) and second space(peritoneal cavity),the third space refers to the intramural space.The aim of the study is to compare value (outcomes/costs) of surgery in patients with SMTs by 2 approaches:Laparoscopic and Endoscopic cooperative surgery(LECS),Robotic and Endoscopic cooperative surgery(RECS).First of all, the investigators will collect 80 cases of SMTs patients, randomly assigned for the LECS and RECS groups. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency,complications and other indicators.


Eligibility criteria: Inclusion Criteria:

* Patients without contraindications gastroscope，surgery and anesthesia;
* Gastroscope found submucosal lesions, qualitative hard;Endoscopic ultrasonography (EUS) confirmed the lesions come from the muscularis propria;
* Tumors diameter \> 2 cm;Or tumors had \< 2 cm, but the position is located in the stomach wall, after nearly cardia and it is a difficult position for gastroscope ;
* Tumors diameter \< 5 cm, the tumors had complete, no broken feed and bleeding;
* Not found the tumor metastasis;
* There is no history of abdominal surgery, no severe abdominal cavity adhesion
* Normal coagulation function;
* There is no history of anticoagulant drugs, or who take aspirin, salvia miltiorrhiza, etc., should stop taking drugs for more than one week;
* Patients and their families volunteered choice the surgical procedure and signed informed consent.

Exclusion Criteria:

* Patients with preoperative assessment of distant metastasis;
* Patients with preoperative radiation and chemotherapy or hormone therapy;
* Patients with acute obstruction, bleeding or perforation of the emergency surgery;
* Patients with a history of abdominal trauma or abdominal surgery;
* Patients with contraindications gastroscope，surgery and anesthesia.

Primary outcomes:
measure: operation time
timeFrame: 1 hours to 6 hours through the surgery completion
Secondary outcomes:
measure: blood loss
timeFrame: 1 hours to 6 hours through the surgery completion
measure: success rate
timeFrame: from two days to two weeks after surgery
measure: time in bed
timeFrame: from two days to two weeks after surgery
measure: time to take food
timeFrame: from two days to two weeks after surgery
measure: postoperative complication rate
timeFrame: from two weeks to one year after surgery
measure: tumor recurrence rate
timeFrame: from one month to 2 years after surgery
measure: hospitalization expenses
timeFrame: 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jun Jun She
role: PRINCIPAL_INVESTIGATOR
References: