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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03082079

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
GIST	Procedure: ESD	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2017

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT03082079

Other Study ID Numbers:

LC2016YM002

First Posted:

Mar 17, 2017

Last Update Posted:

May 16, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nanfang Hospital of Southern Medical University

GIST

ESD

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors

Study Results

No Results Posted as of May 16, 2017