Clinical trial NCT02763748: the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor
Official title: the Prospective, Randomized and Comparative Clinical Study of Laparoscopic and Endoscopic Cooperative Surgery in the Treatment of Gastrointestinal Stromal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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 .


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
* Patients 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: Tumor recurrence rate
timeFrame: 2 years
Secondary outcomes:
measure: the operation time
timeFrame: one hour-five hours
measure: the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）
timeFrame: 2 years
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: