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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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GIST

Intervention / Treatment
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* Procedure: ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female chinese patients of 18-70 years old. Patients with very small gastric GISTs (< 2 cm) with no high-risk EUS features. Patients voluntarily join this study with informed consents. Exclusion Criteria: Patients with the tumors involving the serosa layer or grow outside the lumen obviously that are not eligible for endoscopic treatment. Patients with distant metastasis on computed tomography(CT)scan. patients with an extremely poor general condition or a very short life expectancy. Patients presenting with severe gastrointestinal tract bleeding that require immediate surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD group<br>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<br>* 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<br>|
| No Intervention: Follow-up group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIST, ESD