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

Primary Purpose

Gastric Soft Tissue Neoplasm

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the third space robotic and endoscopic cooperative surgery
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Soft Tissue Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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；

Sites / Locations

  • the First Affiliated Hospital of Xi'an Jiao Tong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients received treatment of TS-RECS

Arm Description

Outcomes

Primary Outcome Measures

the rate of adverse events
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)

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2018
Last Updated
January 11, 2019
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT03804762
Brief Title
A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)
Official Title
Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Soft Tissue Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients received treatment of TS-RECS
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
the third space robotic and endoscopic cooperative surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
the rate of adverse events
Description
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)
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
rate of en bloc resection
Description
the en bloc resection was defined as complete tumor resection with negative surgical margin.
Time Frame
1 day
Title
the rate of intact mucosal layer
Description
intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation
Time Frame
1 day
Title
operation time
Description
Operation time was defined from the time of docking to the time of trocar incision closure.
Time Frame
1 day
Title
estimated blood loss
Description
Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.
Time Frame
1 day
Title
time to oral diet
Description
time to oral diet to assess the postoperative course.
Time Frame
30 days
Title
duration of postoperative hospital stay
Description
From the day of operation to the day of discharged, duration of postoperative hospital stay to assess the postoperative course.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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；
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junjun She, MD,PHD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Xi'an Jiao Tong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31624942
Citation
Shi F, Li Y, Pan Y, Sun Q, Wang G, Yu T, Shi C, Li Y, Xia H, She J. Clinical feasibility and safety of third space robotic and endoscopic cooperative surgery for gastric gastrointestinal stromal tumors dissection : A new surgical technique for treating gastric GISTs. Surg Endosc. 2019 Dec;33(12):4192-4200. doi: 10.1007/s00464-019-07223-w. Epub 2019 Oct 17.
Results Reference
derived

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

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