Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601234
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Procedure: laparoscopic and endoscopic cooperative surgery Procedure: laparoscopic surgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 30, 2019


Arm Intervention/treatment
Experimental: laparoscopic surgery
This is a kind of traditional surgical method.only use laparoscopy to resect the GIST.
Procedure: laparoscopic surgery
the traditional surgery

Experimental: laparoscopic and endoscopic combined surgery
LECS resects the GIST completely by laparoscopy with the help of the precise positioning and guidance of endoscopy.
Procedure: laparoscopic and endoscopic cooperative surgery
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




Primary Outcome Measures :
  1. operation time [ Time Frame: 1 hours to 6 hours through the surgery completion ]
    record in minutes,from the beginning of anesthesia to the end


Secondary Outcome Measures :
  1. blood loss [ Time Frame: 1 hours to 6 hours through the surgery completion ]
    from the surgical record sheet

  2. success rate [ Time Frame: after the pathological report, up to 2 weeks ]
    to ensure the integrity of the tumor and obtain the negative surgical margin

  3. time in bed [ Time Frame: from two days to two weeks after surgery ]
    the time in bed to the postoperative patient

  4. time to take food [ Time Frame: from two days to two weeks after surgery ]
    the time to eat to the postoperative patient

  5. postoperative complication rate [ Time Frame: from two weeks to one year after surgery ]
    including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding

  6. tumor recurrence rate [ Time Frame: from one month to two years after surgery ]
    periodic review the CT or MRI or endoscope

  7. hospitalization expenses [ Time Frame: one month ]
    total hospitalization expenses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601234


Contacts
Layout table for location contacts
Contact: Jun Jun She, M.D; PhD 008618991232713 sjuns@sina.com

Locations
Layout table for location information
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Jun Jun She, M.D.;Ph.D.    0086-18991232713    sjuns@sina.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Fourth Military Medical University
Investigators
Layout table for investigator information
Principal Investigator: Jun Jun She, M.D; PhD First Affiliated Hospital Xi'an Jiaotong University

Layout table for additonal information
Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03601234    
Other Study ID Numbers: XJYFY-2017W44
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: April 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Gastric stromal tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Stromal Tumors
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases