Gastrointestinal Stromal TumorNCT02763748
the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor
A study testing Laparoscopic endoscopy combined surgery, laparoscopic and endoscopic cooperative surgery and Single-arch laparoscopic and endoscopic cooperative surgery in people with Gastrointestinal Stromal Tumor, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation potential, the incidence increased year by year. The surgical resection is the primary treatment for it. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- Laparoscopic endoscopy combined surgery, laparoscopic and endoscopic cooperative surgery and Single-arch laparoscopic and endoscopic cooperative surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to 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 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
- Patients 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: the Prospective, Randomized and Comparative Clinical Study of Laparoscopic and Endoscopic Cooperative Surgery in the Treatment of Gastrointestinal Stromal Tumor
Gastric stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation potential, the incidence increased year by year. The surgical resection is the primary treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of the delicate sense of touch, it could lead to the incomplete resection and disorders of digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic endoscopy combined surgery is different from the past technology. It is a new radical resection of GIST presented by Japanese scholars. LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .This method conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such as incomplete resection and disorders of digestion caused by excessive tissue resection. our team will spearhead the GIST treatment of LECS. First of all, the investigators will collect 120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS, single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and follow-up data, including the operation time, blood loss, the number of transfer laparotomy, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent serval LECS equipment patents and provide some references for LECS applying to the minimally invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- Laparoscopic endoscopy combined surgery, laparoscopic and endoscopic cooperative surgery, Single-arch laparoscopic and endoscopic cooperative surgery
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic endoscopy combined surgeryProcedure or surgery
laparoscopic and endoscopic cooperative surgeryProcedure or surgery
Single-arch laparoscopic and endoscopic cooperative surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic surgery | Experimental | Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method. Receives: Procedure: Laparoscopic endoscopy combined surgery |
| laparoscopic and endoscopic | Experimental | LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy . Receives: Procedure: laparoscopic and endoscopic cooperative surgery |
| Single-arch laparoscopic and endoscopic | Experimental | Single-arch LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy Receives: Procedure: Single-arch laparoscopic and endoscopic cooperative surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence rate
Measured: 2 years
Secondary outcomes (2)
the operation time
Measured: one hour-five hours
the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Jun She, M.D.; PhD., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763748
- Sponsor's protocol ID
- XJTU1AF-CRF-2015-019
- Status last verified
- Feb 2018
- First submitted
- 26 Apr 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Prospective, Randomized and Comparative Clinical Study of Laparoscopic and Endoscopic Cooperative Surgery in the Treatment of Gastrointestinal Stromal Tumor
- ClinicalTrials.gov ID
- NCT02763748
- Acronym / sponsor ID
- XJTU1AF-CRF-2015-019
- Conditions
- Gastrointestinal Stromal Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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 stromal tumor is a gastrointestinal mesenchymal tumor with malignant differentiation potential, the incidence increased year by year. The surgical resection is the primary treatment for it. Although laparoscopic GIST resection has many benefits，due to in lack of the delicate sense of touch, it could lead to the incomplete resection and disorders of digestion. More than 33% of postoperative patients have the gastric dysfunction. Laparoscopic endoscopy combined surgery is different from the past technology. It is a new radical resection of GIST presented by Japanese scholars. LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .This method conforms to the idea of the modern minimally invasive surgery, and avoids many problems，such as incomplete resection and disorders of digestion caused by excessive tissue resection. our team will spearhead the GIST treatment of LECS. First of all, the investigators will collect 120 cases of GIST patients, randomly assigned for the laparoscopic group, the LECS, single-arch the LECS surgical treatment. Secondly, to analyzing the basic treatment and follow-up data, including the operation time, blood loss, the number of transfer laparotomy, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.The purpose of this subject is to observe the effectivity and safety of LECS and single-arch the LECS, invent serval LECS equipment patents and provide some references for LECS applying to the minimally invasive surgery of the digestive tract tumor and multidisciplinary treatment mode .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic surgery | Experimental | Procedure: Laparoscopic endoscopy combined surgeryLaparoscopic endoscopy combined surgery. This is a kind of traditional surgical method. |
| laparoscopic and endoscopic | Experimental | Procedure: laparoscopic and endoscopic cooperative surgeryLECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy . |
| Single-arch laparoscopic and endoscopic | Experimental | Procedure: Single-arch laparoscopic and endoscopic cooperative surgerySingle-arch LECS resects the tumor completely by laparoscopy 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 (7 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 |
|---|---|---|
| Laparoscopic endoscopy combined surgery | Procedure or surgery | Laparoscopic surgery |
| laparoscopic and endoscopic cooperative surgery | Procedure or surgery | laparoscopic and endoscopic |
| Single-arch laparoscopic and endoscopic cooperative surgery | Procedure or surgery | Single-arch laparoscopic and endoscopic |
Primary outcome
Tumor recurrence rate
Time frame: 2 years
2 secondary outcomes
the operation time
Time frame: one hour-five hours
the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: Yes
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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, M.D.; 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 Laparoscopic endoscopy combined surgery, laparoscopic and endoscopic cooperative surgery and Single-arch laparoscopic and endoscopic cooperative surgery in people with Gastrointestinal Stromal Tumor, 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 7 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 7 Feb 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?
Tumor recurrence rate (time frame: 2 years). 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 7 Feb 2018.