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

N/AUnknownNCT03082079

Nanfang Hospital, Southern Medical University90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

GIST

Interventions

ESDPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

progression-free survival

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.

Time frame: 5 years

Secondary Outcomes

tumor recurrence rate

The proportion of the total number of patients with recurrence of each grop, which confirmed by endoscopic and other imaging data during follow-up.

Time frame: 5 years

success rate of operations

The proportion of the total number of patients with GISTs been successfully resected of each group.

Time frame: At surgery

Tumor progression rates

The proportion of the total number of patients with tumor continuing to increase of each group.

Time frame: 5 years

Operation time

It is the time that passes from ESD beginning to complete resection of the tumors.

Time frame: At surgery

Peri-operative bleeding

The amount of bleeding during operation.

Time frame: At surgery

Complications rate

Complications including bleeding and perforation.

Time frame: At surgery

Duration of hospitalization and the total hospital costs

length of hospital stay and all costs related to the operations and examinations and the period of hospitalization.

Central Contacts

yue li, Doctor

CONTACT

15975537291 liyue_1989919@126.com

Data from ClinicalTrials.gov

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