Gastrointestinal Stromal TumorsLECSINGSTNCT03601234
Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors
A study testing laparoscopic and endoscopic cooperative surgery and laparoscopic surgery in people with Gastrointestinal Stromal Tumors, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Gastrointestinal stromal tumor (GIST) is a kind of mesenchymal tumor with malignant differentiation potential. It originated from mesenchymal stem cells of gastrointestinal tract.The most common is that gastric stromal tumors(GST) make up 60-70% of gastrointestinal stromal tumors.The first choice for the treatment of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- laparoscopic and endoscopic cooperative surgery and laparoscopic 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
- 16 Apr 2018to 30 Dec 2019
- 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
Show all 9Show fewer
- 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: Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors
Gastrointestinal stromal tumor (GIST) is a kind of mesenchymal tumor with malignant differentiation potential. It originated from mesenchymal stem cells of gastrointestinal tract.The most common is that gastric stromal tumors(GST) make up 60-70% of gastrointestinal stromal tumors.The first choice for the treatment of non-metastatic gastric stromal tumors is to ensure the integrity of the tumor and obtain the negative surgical margin.At present, the common surgical methods of resection of gastric stromal tumors include laparotomy and laparoscopy, most of them are partial gastrectomy, wedge-shaped resection, proximal subtotal gastrectomy, distal subtotal gastrectomy and total gastrectomy, etc.There was no significant difference between open surgery and laparoscopic surgery.With the rapid development of endoscopic technology in recent years, endoscopes have been continuously explored in practice.Laparoscopic endoscopic cooperative surgery(LECS) 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. Investigators will observe the diffenrence of LECS and traditional laparoscopic surgeries.Firstly,the investigators will collect 80 cases of GST patients, randomly assigned for the laparoscopic group, 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 or laparoscopy, 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 , 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.It also provides reference for gastrointestinal stromal tumors, leiomyomas, ectopic pancreas, carcinoid, early carcinomas, giant adenomas and polyps.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- laparoscopic and endoscopic cooperative surgery, laparoscopic surgery
- Keywords
- Gastric stromal tumors
- 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 and endoscopic cooperative surgeryProcedure or surgery
compare to the traditional surgery to resect the tumor,we will add the endoscopy during the operation to improve the safety and effectiveness of surgery
laparoscopic surgeryProcedure or surgery
the traditional surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic surgery | Experimental | This is a kind of traditional surgical method.only use laparoscopy to resect the GIST. Receives: Procedure: laparoscopic surgery |
| laparoscopic and endoscopic combined surgery | Experimental | LECS resects the GIST completely by laparoscopy with the help of the precise positioning and guidance of endoscopy. Receives: Procedure: laparoscopic and endoscopic cooperative 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: after the pathological report, up to 2 weeks
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 two years after surgery
hospitalization expenses
total hospitalization expenses
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Apr 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- 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
- NCT03601234
- Sponsor's protocol ID
- XJYFY-2017W44
- Acronym
- LECSINGST
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors
- ClinicalTrials.gov ID
- NCT03601234
- Acronym / sponsor ID
- LECSINGST / XJYFY-2017W44
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastric stromal tumors
- 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
- 16 Apr 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 26 Jul 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.
Gastrointestinal stromal tumor (GIST) is a kind of mesenchymal tumor with malignant differentiation potential. It originated from mesenchymal stem cells of gastrointestinal tract.The most common is that gastric stromal tumors(GST) make up 60-70% of gastrointestinal stromal tumors.The first choice for the treatment of non-metastatic gastric stromal tumors is to ensure the integrity of the tumor and obtain the negative surgical margin.At present, the common surgical methods of resection of gastric stromal tumors include laparotomy and laparoscopy, most of them are partial gastrectomy, wedge-shaped resection, proximal subtotal gastrectomy, distal subtotal gastrectomy and total gastrectomy, etc.There was no significant difference between open surgery and laparoscopic surgery.With the rapid development of endoscopic technology in recent years, endoscopes have been continuously explored in practice.Laparoscopic endoscopic cooperative surgery(LECS) 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. Investigators will observe the diffenrence of LECS and traditional laparoscopic surgeries.Firstly,the investigators will collect 80 cases of GST patients, randomly assigned for the laparoscopic group, 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 or laparoscopy, 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 , 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.It also provides reference for gastrointestinal stromal tumors, leiomyomas, ectopic pancreas, carcinoid, early carcinomas, giant adenomas and polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic surgery | Experimental | Procedure: laparoscopic surgeryThis is a kind of traditional surgical method.only use laparoscopy to resect the GIST. |
| laparoscopic and endoscopic combined surgery | Experimental | Procedure: laparoscopic and endoscopic cooperative surgeryLECS resects the GIST 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 (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 |
|---|---|---|
| laparoscopic and endoscopic cooperative surgerycompare to the traditional surgery to resect the tumor,we will add the endoscopy during the operation to improve the safety and effectiveness of surgery | Procedure or surgery | laparoscopic and endoscopic combined surgery |
| laparoscopic surgerythe traditional surgery | Procedure or surgery | laparoscopic surgery |
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: after the pathological report, up to 2 weeks
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 two years after surgery
hospitalization expenses
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Related trials for Gastrointestinal Stromal Tumors
RecruitingObservational study
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
Colorectal Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
RecruitingPhase 2
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
RecruitingPhase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrointestinal Stromal Tumor (GIST), Gastrointestinal Stromal Cancer
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 and endoscopic cooperative surgery and laparoscopic surgery in people with Gastrointestinal Stromal 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 26 Jul 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 26 Jul 2018.