the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor

February 6, 2018 updated by: First Affiliated Hospital Xi'an Jiaotong University

the Prospective, Randomized and Comparative Clinical Study of Laparoscopic and Endoscopic Cooperative Surgery in the Treatment of Gastrointestinal Stromal Tumor

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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

  • ADULT
  • OLDER_ADULT
  • CHILD

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
  • 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;

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic surgery
Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.
Procedure: Laparoscopic endoscopy combined surgery
EXPERIMENTAL: laparoscopic and endoscopic
LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy .
Procedure: laparoscopic and endoscopic cooperative surgery
EXPERIMENTAL: 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
Procedure: Single-arch laparoscopic and endoscopic cooperative surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor recurrence rate
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
the all number of postoperative complications（ frequency,reflux esophagitis and bile reflux gastritis）
Time Frame: 2 years
2 years
the operation time
Time Frame: one hour-five hours
one hour-five hours

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

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

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (ESTIMATE)

May 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2015-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

Clinical Trials on Gastrointestinal Stromal Tumor

Clinical Trials on Laparoscopic endoscopy combined surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe