the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor
Primary Purpose
Gastrointestinal Stromal Tumor
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Laparoscopic endoscopy combined surgery
laparoscopic and endoscopic cooperative surgery
Single-arch laparoscopic and endoscopic cooperative surgery
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor
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;
Sites / Locations
- First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Laparoscopic surgery
laparoscopic and endoscopic
Single-arch laparoscopic and endoscopic
Arm Description
Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
Single-arch LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
Outcomes
Primary Outcome Measures
Tumor recurrence rate
Secondary Outcome Measures
the operation time
the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)
Full Information
NCT ID
NCT02763748
First Posted
April 26, 2016
Last Updated
February 6, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
1. Study Identification
Unique Protocol Identification Number
NCT02763748
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic surgery
Arm Type
Experimental
Arm Description
Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.
Arm Title
laparoscopic and endoscopic
Arm Type
Experimental
Arm Description
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
Arm Title
Single-arch laparoscopic and endoscopic
Arm Type
Experimental
Arm Description
Single-arch LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic endoscopy combined surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic and endoscopic cooperative surgery
Intervention Type
Procedure
Intervention Name(s)
Single-arch laparoscopic and endoscopic cooperative surgery
Primary Outcome Measure Information:
Title
Tumor recurrence rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
the operation time
Time Frame
one hour-five hours
Title
the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Jun She, M.D; PhD
Phone
008618991232713
Email
sjuns@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Jun She, M.D.; PhD.
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Jun She, M.D.;Ph.D.
Phone
0086-18991232713
Email
sjuns@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor
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