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

NCT03612830 | Unknown

• 1 other identifier: XJYFY-2018W411
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Submucosal Tumors

Keywords

The Third Space

Outcome Measures

Primary Outcomes (1)

• operation time

  record in minutes,from the beginning of anesthesia to the end

  1 hours to 6 hours through the surgery completion

Secondary Outcomes (7)

• blood loss

  1 hours to 6 hours through the surgery completion

• success rate

  from two days to two weeks after surgery

• time in bed

  from two days to two weeks after surgery

• time to take food

  from two days to two weeks after surgery

• postoperative complication rate

  from two weeks to one year after surgery

Study Arms (2)

LECS

EXPERIMENTAL

Laparoscopic and Endoscopic cooperative surgery,LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .

Procedure: Laparoscopy endoscopy cooperated surgery

RECS

EXPERIMENTAL

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 .

Procedure: Dan Vinchi robot endoscopy cooperated surgery

Interventions

Laparoscopy endoscopy cooperated surgery PROCEDURE

LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy

LECS

Dan Vinchi robot endoscopy cooperated surgery PROCEDURE

RECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy

RECS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Air Force Military Medical University, China: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

• Jun Jun She

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jun She, M.D; PhD

CONTACT

008618991232713; sjuns@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Laparoscopic and Endoscopic cooperative sugery,Robotic and Endoscopic cooperative sugery

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: August 2, 2018
• Study Start: April 11, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 15, 2018

Record last verified: 2018-04

Locations

CN (1)