Gastric Submucosal TumorsRECSINSMTsNCT03612830
A Randomized Controlled Clinical Study on the Application of the Third Space in the Operation of Gastric Submucosal Tumor
A study testing Laparoscopy endoscopy cooperated surgery and Dan Vinchi robot endoscopy cooperated surgery in people with Gastric Submucosal Tumors, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Submucosal Tumors
- What is being tested?
- Laparoscopy endoscopy cooperated surgery and Dan Vinchi robot endoscopy cooperated surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2018to 30 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jun Jun She, M.D.;Ph.D., 0086-18991232713, sjuns@sina.com
About this study
Official title: 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.
- Conditions
- Gastric Submucosal Tumors
- Being tested
- Laparoscopy endoscopy cooperated surgery, Dan Vinchi robot endoscopy cooperated surgery
- Keywords
- The Third Space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopy endoscopy cooperated surgeryProcedure or surgery
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
Dan Vinchi robot endoscopy cooperated surgeryProcedure or surgery
RECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy
| Study group | Role | What they receive |
|---|---|---|
| LECS | Experimental | Laparoscopic and Endoscopic cooperative surgery,LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy . Receives: Procedure: Laparoscopy endoscopy cooperated surgery |
| RECS | Experimental | 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 . Receives: Procedure: Dan Vinchi robot endoscopy cooperated surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
record in minutes,from the beginning of anesthesia to the end
Measured: 1 hours to 6 hours through the surgery completion
Secondary outcomes (7)
blood loss
from the surgical record sheet
Measured: 1 hours to 6 hours through the surgery completion
success rate
to ensure the integrity of the tumor and obtain the negative surgical margin
Measured: from two days to two weeks after surgery
time in bed
the time in bed to the postoperative patient
Measured: from two days to two weeks after surgery
time to take food
the time to eat to the postoperative patient
Measured: from two days to two weeks after surgery
postoperative complication rate
including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
Measured: from two weeks to one year after surgery
tumor recurrence rate
periodic review the CT or MRI or endoscope
Measured: from one month to 2 years after surgery
hospitalization expenses
total hospitalization expenses
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start11 Apr 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Submucosal TumorsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Laparoscopic and Endoscopic cooperative sugery,Robotic and Endoscopic cooperative sugery
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Jun Jun She, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612830
- Sponsor's protocol ID
- XJYFY-2018W411
- Acronym
- RECSINSMTs
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic and Endoscopic Cooperative Surgery and Robotic and Endoscopic Cooperative Surgery in the Operation of Gastric Submucosal Tumor
- ClinicalTrials.gov ID
- NCT03612830
- Acronym / sponsor ID
- RECSINSMTs / XJYFY-2018W411
- Conditions
- Gastric Submucosal Tumors
- Keywords
- The Third Space
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 2 Aug 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Laparoscopic and Endoscopic cooperative sugery,Robotic and Endoscopic cooperative sugery
| Arm | Type | Receives |
|---|---|---|
| LECS | Experimental | Procedure: Laparoscopy endoscopy cooperated surgeryLaparoscopic and Endoscopic cooperative surgery,LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy . |
| RECS | Experimental | Procedure: Dan Vinchi robot endoscopy cooperated surgeryRobotic and Endoscopic cooperative surgery,RECS resects the tumor completely by Dan Vinchi robot with the help of the precise positioning and guidance of endoscopy . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Laparoscopy endoscopy cooperated surgeryLECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy | Procedure or surgery | LECS |
| Dan Vinchi robot endoscopy cooperated surgeryRECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy | Procedure or surgery | RECS |
Primary outcome
operation time
Time frame: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
7 secondary outcomes
blood loss
Time frame: 1 hours to 6 hours through the surgery completion
success rate
Time frame: from two days to two weeks after surgery
time in bed
Time frame: from two days to two weeks after surgery
time to take food
Time frame: from two days to two weeks after surgery
postoperative complication rate
Time frame: from two weeks to one year after surgery
tumor recurrence rate
Time frame: from one month to 2 years after surgery
hospitalization expenses
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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.
Jun Jun She 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 Laparoscopy endoscopy cooperated surgery and Dan Vinchi robot endoscopy cooperated surgery in people with Gastric Submucosal Tumors, 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Jun She, M.D; PhD (008618991232713, sjuns@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: 1 hours to 6 hours through the surgery completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2018.