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

August 13, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

Comparison of Laparoscopic and Endoscopic Cooperative Surgery and Robotic and Endoscopic Cooperative Surgery in the Operation of Gastric Submucosal Tumor

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LECS
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
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
Experimental: RECS
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
RECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
1 hours to 6 hours through the surgery completion

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Jun Jun She, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

July 27, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XJYFY-2018W411

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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