the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor

NCT ID: NCT02763748

Last Updated: 2018-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

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 .

Conditions

Gastrointestinal Stromal Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Laparoscopic surgery

Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.

Group Type: EXPERIMENTAL

Laparoscopic endoscopy combined surgery

Intervention Type: PROCEDURE

laparoscopic and endoscopic

LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .

Group Type: EXPERIMENTAL

laparoscopic and endoscopic cooperative surgery

Intervention Type: PROCEDURE

Single-arch laparoscopic and endoscopic

Single-arch LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy

Group Type: EXPERIMENTAL

Single-arch laparoscopic and endoscopic cooperative surgery

Intervention Type: PROCEDURE

Interventions

Laparoscopic endoscopy combined surgery

Intervention Type: PROCEDURE

laparoscopic and endoscopic cooperative surgery

Intervention Type: PROCEDURE

Single-arch laparoscopic and endoscopic cooperative surgery

Intervention Type: PROCEDURE

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Jun She, M.D.; PhD.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Jun She, M.D; PhD

Role: CONTACT

sjuns@sina.com

008618991232713

Facility Contacts

Jun Jun She, M.D.;Ph.D.

Role: primary

sjuns@sina.com

0086-18991232713

Other Identifiers

XJTU1AF-CRF-2015-019

Identifier Type: -

Identifier Source: org_study_id