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Status unknownNCT02763748Updated Feb 7, 2018

the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor

An interventional study of Laparoscopic endoscopy combined surgery and laparoscopic and endoscopic cooperative surgery in Gastrointestinal Stromal Tumor, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
01

Study 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 .

02

Conditions studied

  • Gastrointestinal Stromal Tumor
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In context

Gastrointestinal Stromal Tumors

333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.

This study's planned enrollment of 120 is above the median of 50 across 243 interventional studies indexed under Gastrointestinal Stromal Tumors.

Browse Gastrointestinal Stromal Tumors studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureLaparoscopic endoscopy combined surgery
  • Procedurelaparoscopic and endoscopic cooperative surgery
  • ProcedureSingle-arch laparoscopic and endoscopic cooperative surgery
06

What researchers measure

Primary outcomes

  1. Tumor recurrence rate

    Time frame: 2 years

Secondary outcomes

  1. the operation time

    Time frame: one hour-five hours

  2. the all number of postoperative complications( frequency,reflux esophagitis and bile reflux gastritis)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    • Jun Jun She, M.D.;Ph.D. · Contact · sjuns@sina.com · 0086-18991232713
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02763748
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
May 5, 2016
Start date
Jun 2016
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Feb 7, 2018

Study contacts

Jun Jun She, M.D; PhD
Contact
sjuns@sina.com
008618991232713
Jun Jun She, M.D.; PhD.
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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