Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor Clinical Trial

— CELSGIST  

Official title:

Comparison of Endoscopic and Laparoscopic Resection for Small Gastric

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03471273
• Other study ID #: LC2016ZD013
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2018
• Last updated: March 13, 2018
• Start date: September 18, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Lan Bai, Doctor
• Phone: 15692428926
• Email: stellaff[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years old Chinese;

• Definite diagnosis or endoscopic ultrasonography, CT and other highly suspected Chinese patients with gastric stromal tumors;

• Patients voluntarily signed informed consent and have been orally informed of the specific trial plan.

Exclusion Criteria:

• Patients with gastric stromal tumors with distant metastasis who cannot be treated by laparoscopic surgery;

• Combined heart , cerebrovascular , liver , kidney , and hematopoietic system serious primary disease;

• gastric stromal tumors with severe digestive tract hemorrhage endanger the immediate surgical treatment of life;

• The investigator considers that it is not suitable for this test.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors
• Therapeutic Value of Endoscopic and Laparoscopic Resection for Small Gastric Gastrointestinal Stromal Tumor

Intervention

Procedure:
• endoscopic management, surgery and follow up
endoscopic management, surgery and follow up

Locations

Country	Name	City	State
China	Nanfang Hospistal	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recur or not in 2 years after endoscopic surgical procedure or surgery	Participants will be followed up for 2 years after endoscopic surgical procedure or surgery by endoscope and/or endoscopic ultrasonography.	2 years after endoscopic surgical procedure or surgery