Clinical trial NCT03601234: Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors
Official title: Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Stromal Tumors
Keywords: Gastric stromal tumors
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2018-07-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: operation time
timeFrame: 1 hours to 6 hours through the surgery completion
Secondary outcomes:
measure: blood loss
timeFrame: 1 hours to 6 hours through the surgery completion
measure: success rate
timeFrame: after the pathological report, up to 2 weeks
measure: time in bed
timeFrame: from two days to two weeks after surgery
measure: time to take food
timeFrame: from two days to two weeks after surgery
measure: postoperative complication rate
timeFrame: from two weeks to one year after surgery
measure: tumor recurrence rate
timeFrame: from one month to two years after surgery
measure: hospitalization expenses
timeFrame: one month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Jun Jun She, M.D; PhD
role: PRINCIPAL_INVESTIGATOR
References: