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

July 17, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

Application of Laparoscopy Combined With Endoscopy Surgery in the Treatment of Gastric Stromal Tumors

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operation time
Time Frame: 1 hours to 6 hours through the surgery completion
record in minutes,from the beginning of anesthesia to the end
1 hours to 6 hours through the surgery completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood loss
Time Frame: 1 hours to 6 hours through the surgery completion
from the surgical record sheet
1 hours to 6 hours through the surgery completion
time in bed
Time Frame: from two days to two weeks after surgery
the time in bed to the postoperative patient
from two days to two weeks after surgery
time to take food
Time Frame: from two days to two weeks after surgery
the time to eat to the postoperative patient
from two days to two weeks after surgery
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
after the pathological report, up to 2 weeks
postoperative complication rate
Time Frame: from two weeks to one year after surgery
including anastomotic stoma fistula,anastomotic stenosis,abdominal infection,postoperative bleeding
from two weeks to one year after surgery
tumor recurrence rate
Time Frame: from one month to two years after surgery
periodic review the CT or MRI or endoscope
from one month to two years after surgery
hospitalization expenses
Time Frame: one month
total hospitalization expenses
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Jun Jun She, M.D; PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

April 25, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJYFY-2017W44

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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