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

Not Applicable

• Conditions: GIST
• Interventions: Procedure: ESD

• Registration Number: NCT03082079
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

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 Timeline

• Status Verified: 2017-02
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-17
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16
• Study Start: 2017-06-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESD group	ESD	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.

Primary Outcome Measures

Name	Time	Method
progression-free survival	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.

Secondary Outcome Measures

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