Clinical trial NCT03082079: Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm)
Official title: Long Outcome of Endoscopic Submucosal Dissection for Small Gastrointestinal Stromal Tumors (<2cm) :a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GIST
Keywords: GIST
ESD
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: tumor recurrence rate
timeFrame: 5 years
measure: success rate of operations
timeFrame: At surgery
measure: Tumor progression rates
timeFrame: 5 years
measure: Operation time
timeFrame: At surgery
measure: Peri-operative bleeding
timeFrame: At surgery
measure: Complications rate
timeFrame: At surgery
measure: Duration of hospitalization and the total hospital costs
timeFrame: through the whole recovery, an average of 10 days
measure: Histological curative resection
timeFrame: At surgery
measure: patient satisfaction scores
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: yue li, Doctor
role: STUDY_CHAIR
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