Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)

May 14, 2017 updated by: Nanfang Hospital of Southern Medical University

Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial

Data are currently insufficient to guide the management of very small gastrointestinal stromal tumors（GISTs）（< 2 cm) discovered incidentally on endoscopy,this study is designed to collect the medical records of patients in different treatment group with long-term follow-up data,and attempts to evaluate the usefulness of regular endoscopic ultrasound（EUS）surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD）for small GISTs,thus provide evidence for the revision of the guideline.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTION:to evaluate the usefulness of regular endoscopic ultrasound（EUS） surveillance and the necessity,safety and feasibility of endoscopic submucosal dissection（ESD） for small GISTs(<2cm),thus providing evidences for the revision of the guideline.

OUTLINE:This is a randomized controlled trial. Eligible patients are divided into 2 group with 45 in each.The experimental group undergo ESD for GISTs,while the investigators do no treatment to the control group.Then,the 2 groups will be follow up for 5 years.All data are analysed with the Statistical Product and Service Solutions（SPSS）statistical software.

Study Type

Interventional

Enrollment (Anticipated)

90

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.

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:

  1. Male or female chinese patients of 18-70 years old.
  2. Patients with very small gastric GISTs (< 2 cm) with no high-risk EUS features.
  3. Patients voluntarily join this study with informed consents.

Exclusion Criteria:

  1. Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment.
  2. Patients with distant metastasis on computed tomography(CT)scan.
  3. patients with an extremely poor general condition or a very short life expectancy.
  4. Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESD group
Patient in this group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate.
Procedure: ESD
Patient in ESD group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate
No Intervention: Follow-up group
Patient in this group are given no intervention,the investigators record the tumor size and EUS features of the first endoscopic examination.Regular follow-up are carried out for these patients on 3 month,6 month,1 year,2 year,3 year,4 year,5 year after this check.Then,tumor size and EUS features of each time are collected accurately.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: 5 years
It is the time that passes from a patient is enrolled in this clinical trial to the date on which disease "progresses" or the date on which the patient dies, from any cause.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor recurrence rate
Time Frame: 5 years
The proportion of the total number of patients with recurrence of each grop, which confirmed by endoscopic and other imaging data during follow-up.
5 years
success rate of operations
Time Frame: At surgery
The proportion of the total number of patients with GISTs been successfully resected of each group.
At surgery
Tumor progression rates
Time Frame: 5 years
The proportion of the total number of patients with tumor continuing to increase of each group.
5 years
Operation time
Time Frame: At surgery
It is the time that passes from ESD beginning to complete resection of the tumors.
At surgery
Peri-operative bleeding
Time Frame: At surgery
The amount of bleeding during operation.
At surgery
Complications rate
Time Frame: At surgery
Complications including bleeding and perforation.
At surgery
Duration of hospitalization and the total hospital costs
Time Frame: through the whole recovery, an average of 10 days
length of hospital stay and all costs related to the operations and examinations and the period of hospitalization.
through the whole recovery, an average of 10 days
Histological curative resection
Time Frame: At surgery
Histological curative resection is defined as complete tumor removal which confirmed by pathological assessment of resected tissue
At surgery
patient satisfaction scores
Time Frame: 5 years
We administer questionnaires to each patients,and invite them to score for this treatment or examination.
5 years

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Study Chair: yue li, Doctor, Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LC2016YM002

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

product manufactured in and exported from the U.S.

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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