Gastric Soft Tissue NeoplasmNCT03804762
A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)
A study testing the third space robotic and endoscopic cooperative surgery in people with Gastric Soft Tissue Neoplasm, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Soft Tissue Neoplasm
- What is being tested?
- the third space robotic and endoscopic cooperative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
About this study
Official title: 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.
- Conditions
- Gastric Soft Tissue Neoplasm
- Being tested
- the third space robotic and endoscopic cooperative surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the third space robotic and endoscopic cooperative surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| patients received treatment of TS-RECS | Experimental | Not described Receives: Procedure: the third space robotic and endoscopic cooperative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: through study completion, an average of 6 months
Secondary outcomes (6)
rate of en bloc resection
the en bloc resection was defined as complete tumor resection with negative surgical margin.
Measured: 1 day
the rate of intact mucosal layer
intact mucosal layer was defined as the tumor resection without full-thickness incision caused by operation
Measured: 1 day
operation time
Operation time was defined from the time of docking to the time of trocar incision closure.
Measured: 1 day
estimated blood loss
Blood loss was estimated through the analysis of the surgical and anaesthesiological reports.
Measured: 1 day
time to oral diet
time to oral diet to assess the postoperative course.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start5 Apr 2018
- Primary completion15 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Soft Tissue NeoplasmStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junjun She, MD,PHD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804762
- Sponsor's protocol ID
- XJTU1AF2018LSK-168
- Status last verified
- Apr 2018
- First submitted
- 23 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31624942
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor
- ClinicalTrials.gov ID
- NCT03804762
- Acronym / sponsor ID
- XJTU1AF2018LSK-168
- Conditions
- Gastric Soft Tissue Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients received treatment of TS-RECS | Experimental | Procedure: the third space robotic and endoscopic cooperative surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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；
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the third space robotic and endoscopic cooperative surgeryThis 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. | Procedure or surgery | patients received treatment of TS-RECS |
Primary outcome
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)
6 secondary outcomes
rate of en bloc resection
Time frame: 1 day
the rate of intact mucosal layer
Time frame: 1 day
operation time
Time frame: 1 day
estimated blood loss
Time frame: 1 day
time to oral diet
Time frame: 30 days
duration of postoperative hospital stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 31624942Shi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junjun She, MD,PHD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the third space robotic and endoscopic cooperative surgery in people with Gastric Soft Tissue Neoplasm, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of adverse events (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.