A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)

January 11, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University

Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor

The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
        • The First Affiliated Hospital of Xi'an Jiao Tong 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)；
  • The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ；
  • No evidence of tumor metastasis on all per-operative evaluations；

Exclusion Criteria:

  • 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension;
  • 2. Patients with advanced malignant tumor;
  • 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor;
  • 4.Patients with ulcer penetration into tumors;
  • 5. Patients with the contraindications for general anesthesia;
  • 6. Patients were pregnant or younger than 18 years old；

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients received treatment of TS-RECS
Procedure: the third space robotic and endoscopic cooperative surgery
This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of adverse events
Time Frame: through study completion, an average of 6 months
Adverse events included intraoperative adverse (full-thickness perforation, hemorrhage, injury of visceral organs and vessel, and anaesthesia complications), and postoperative adverse events (infectious complications, intra-abdominal /intraluminal bleeding, gastric stasis and leakage)
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of en bloc resection
Time Frame: 1 day
the en bloc resection was defined as complete tumor resection with negative surgical margin.
1 day
the rate of intact mucosal layer
Time Frame: 1 day
intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation
1 day
operation time
Time Frame: 1 day
Operation time was defined from the time of docking to the time of trocar incision closure.
1 day
estimated blood loss
Time Frame: 1 day
Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.
1 day
time to oral diet
Time Frame: 30 days
time to oral diet to assess the postoperative course.
30 days
duration of postoperative hospital stay
Time Frame: 30 days
From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.
30 days

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Principal Investigator: Junjun She, MD,PHD, First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 5, 2018

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 20, 2018

Study Registration Dates

First Submitted

December 23, 2018

First Submitted That Met QC Criteria

January 11, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF2018LSK-168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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