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

March 13, 2018 updated by: Nanfang Hospital of Southern Medical University

Comparison of Endoscopic and Laparoscopic Resection for Small Gastric

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

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 Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospistal
        • Contact:

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: surgery
Procedure: endoscopic management, surgery and follow up
endoscopic management, surgery and follow up
OTHER: endoscopic management
Procedure: endoscopic management, surgery and follow up
endoscopic management, surgery and follow up
OTHER: follow up
Procedure: endoscopic management, surgery and follow up
endoscopic management, surgery and follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recur or not in 2 years after endoscopic surgical procedure or surgery
Time Frame: 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

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Shenzhen Hospital of Southern Medical 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 (ACTUAL)

September 18, 2017

Primary Completion (ANTICIPATED)

October 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2016ZD013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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