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

NCT03612830 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-15

No results posted yet for this study

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

Interventions

PROCEDURE

Laparoscopy endoscopy cooperated surgery

LECS resects the tumor completely by laparoscopy 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

Sponsors & Collaborators

  • Air Force Military Medical University, China

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Jun Jun She · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2020-06-30
Completion
2020-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03612830 on ClinicalTrials.gov