A Randomized Controlled Clinical Study on the Application of the Third Space in the Operation of Gastric Submucosal Tumor

Not Applicable

• Conditions: Gastric Submucosal Tumors
• Interventions: Procedure: Laparoscopy endoscopy cooperated surgery; Procedure: Dan Vinchi robot endoscopy cooperated surgery

• Registration Number: NCT03612830
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-11
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-08-02
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LECS	Laparoscopy endoscopy cooperated surgery	Laparoscopic and Endoscopic cooperative surgery,LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
RECS	Dan Vinchi robot endoscopy cooperated surgery	Robotic and Endoscopic cooperative surgery,RECS resects the tumor completely by Dan Vinchi robot with the help of the precise positioning and guidance of endoscopy .

Primary Outcome Measures

Name	Time	Method
operation time	1 hours to 6 hours through the surgery completion	record in minutes,from the beginning of anesthesia to the end

Secondary Outcome Measures

Name	Time	Method
time to take food	from two days to two weeks after surgery	the time to eat to the postoperative patient
time in bed	from two days to two weeks after surgery	the time in bed to the postoperative patient
blood loss	1 hours to 6 hours through the surgery completion	from the surgical record sheet
success rate	from two days to two weeks after surgery	to ensure the integrity of the tumor and obtain the negative surgical margin
postoperative complication rate	from two weeks to one year after surgery	including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
tumor recurrence rate	from one month to 2 years after surgery	periodic review the CT or MRI or endoscope
hospitalization expenses	1 month	total hospitalization expenses

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China