Laparoscopic Endoscopic Cooperative Surgery in the Treatment of Gastric Stromal Tumors

NCT03601234 | Unknown

• 1 other identifier: XJYFY-2017W44
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastric stromal tumors

Outcome Measures

Primary Outcomes (1)

• operation time

  record in minutes,from the beginning of anesthesia to the end

  1 hours to 6 hours through the surgery completion

Secondary Outcomes (7)

• blood loss

  1 hours to 6 hours through the surgery completion

• success rate

  after the pathological report, up to 2 weeks

• time in bed

  from two days to two weeks after surgery

• time to take food

  from two days to two weeks after surgery

• postoperative complication rate

  from two weeks to one year after surgery

Study Arms (2)

laparoscopic surgery

EXPERIMENTAL

This is a kind of traditional surgical method.only use laparoscopy to resect the GIST.

Procedure: laparoscopic surgery

laparoscopic and endoscopic combined surgery

EXPERIMENTAL

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

Procedure: laparoscopic and endoscopic cooperative surgery

Interventions

laparoscopic and endoscopic cooperative surgery PROCEDURE

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

laparoscopic and endoscopic combined surgery

laparoscopic surgery PROCEDURE

the traditional surgery

laparoscopic surgery

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
• 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.

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
• Air Force Military Medical University, China: collaborator

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: July 26, 2018
• Study Start: April 16, 2018
• Primary Completion: June 1, 2019
• Study Completion: December 30, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-04

Locations

CN (1)