the Laparoscopic and Endoscopic Cooperative Surgery of Gastrointestinal Stromal Tumor

NCT02763748 | Unknown

• 1 other identifier: XJTU1AF-CRF-2015-019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (1)

• Tumor recurrence rate

  2 years

Secondary Outcomes (2)

• the operation time

  one hour-five hours

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

  2 years

Study Arms (3)

Laparoscopic surgery

EXPERIMENTAL

Laparoscopic endoscopy combined surgery. This is a kind of traditional surgical method.

Procedure: Laparoscopic endoscopy combined surgery

laparoscopic and endoscopic

EXPERIMENTAL

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

Procedure: laparoscopic and endoscopic cooperative surgery

Single-arch laparoscopic and endoscopic

EXPERIMENTAL

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

Laparoscopic endoscopy combined surgery PROCEDURE

Laparoscopic surgery

laparoscopic and endoscopic cooperative surgery PROCEDURE

laparoscopic and endoscopic

Single-arch laparoscopic and endoscopic cooperative surgery PROCEDURE

Single-arch laparoscopic and endoscopic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jun Jun She, M.D.; PhD.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Jun She, M.D; PhD

CONTACT

008618991232713; sjuns@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)