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Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors (LECSINGST)

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
laparoscopic and endoscopic cooperative surgery
laparoscopic surgery
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastric stromal tumors

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

laparoscopic surgery

laparoscopic and endoscopic combined surgery

Arm Description

This is a kind of traditional surgical method.only use laparoscopy to resect the GIST.

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

Outcomes

Primary Outcome Measures

operation time
record in minutes,from the beginning of anesthesia to the end

Secondary Outcome Measures

blood loss
from the surgical record sheet
success rate
to ensure the integrity of the tumor and obtain the negative surgical margin
time in bed
the time in bed to the postoperative patient
time to take food
the time to eat to the postoperative patient
postoperative complication rate
including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
tumor recurrence rate
periodic review the CT or MRI or endoscope
hospitalization expenses
total hospitalization expenses

Full Information

First Posted
April 25, 2018
Last Updated
July 17, 2018
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT03601234
Brief Title
Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors
Acronym
LECSINGST
Official Title
Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastric stromal tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic surgery
Arm Type
Experimental
Arm Description
This is a kind of traditional surgical method.only use laparoscopy to resect the GIST.
Arm Title
laparoscopic and endoscopic combined surgery
Arm Type
Experimental
Arm Description
LECS resects the GIST completely by laparoscopy with the help of the precise positioning and guidance of endoscopy.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic and endoscopic cooperative surgery
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Description
the traditional surgery
Primary Outcome Measure Information:
Title
operation time
Description
record in minutes,from the beginning of anesthesia to the end
Time Frame
1 hours to 6 hours through the surgery completion
Secondary Outcome Measure Information:
Title
blood loss
Description
from the surgical record sheet
Time Frame
1 hours to 6 hours through the surgery completion
Title
success rate
Description
to ensure the integrity of the tumor and obtain the negative surgical margin
Time Frame
after the pathological report, up to 2 weeks
Title
time in bed
Description
the time in bed to the postoperative patient
Time Frame
from two days to two weeks after surgery
Title
time to take food
Description
the time to eat to the postoperative patient
Time Frame
from two days to two weeks after surgery
Title
postoperative complication rate
Description
including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
Time Frame
from two weeks to one year after surgery
Title
tumor recurrence rate
Description
periodic review the CT or MRI or endoscope
Time Frame
from one month to two years after surgery
Title
hospitalization expenses
Description
total hospitalization expenses
Time Frame
one month

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 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.
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

Learn more about this trial

Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors

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