Endoscopic Unroofing for Small Gastric SETs

October 26, 2015 updated by: Werner Dolak, MD, Medical University of Vienna

A Retrospective Study on Safety, Diagnostic Yield and Therapeutic Effects of Endoscopic Unroofing for Small Gastric Subepithelial Tumors

Background: Accurate diagnosis of small gastric subepithelial tumors (SETs) is essential in order to assess their malignant potential. Endoscopic unroofing by conventional snare or needle knife has been reported to yield sufficient tissue samples for histological evaluation including immunohistochemical staining.

Aims: The investigators aim to evaluate endoscopic unroofing in patients with small gastric SETs regarding its safety and diagnostic accuracy as well as a potential therapeutic effect of this technique over time.

Methods: In the context of a retrospective analysis, the investigators will identify patients who underwent endoscopic unroofing of small SETs of the stomach at the Medical University of Vienna. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.

Study Overview

Status

Unknown

Conditions

Detailed Description

INTRODUCTION

Small gastric subepithelial tumors (SETs) are often incidental findings at upper endoscopy. Differential diagnoses include a variety of different pathologies such as gastrointestinal stromal tumors (GISTs), leiomyomas, leiomyosarcomas, lipomas, carcinoid tumors, granular cell tumors, duplication cysts or pancreatic rests. Since some of these entities have a potential of malignancy, accurate classification of gastric SETs is essential to define the best diagnostic and therapeutic management. Endosonography (EUS) is the current gold standard for further characterization of small gastric SETs. It provides differentiation between extra- and intramural lesions, information on the involvement of certain wall layers, measurement of a lesion as well as structural analysis according to the echogenicity of a lesion. Nevertheless, a level of uncertainty remains, even if a lesion shows a typical echo-pattern and layer involvement.

According to current guidelines, lesions of more than two centimeters in size that are suspected to be GISTs should be removed by surgical resection. Lesions less than one centimeter can be followed by annual EUS. For lesions bigger than one centimeter but smaller than two centimeters tissue sampling is recommended in order to correctly diagnose a lesion according to immunohistochemical markers (such as CD117 or CD34 in GISTs) and to quantify the malignant potential according to other histological factors (such as the mitotic index in GISTs) [1].

Tissue sampling can be done by using standard or jumbo forceps biopsy and EUS-guided fine needle aspiration or biopsy, but the diagnostic yield of these methods is rather low [2,3]. Better results can be achieved by endoscopic resection techniques such as endoscopic submucosal dissection (ESD), submucosal tunneling endoscopic resection or full thickness endoscopic resection [4,5]. The main advantage of these approaches is that they are not only diagnostic but also therapeutic strategies since the respective lesion can be resected as a whole comparable with conventional surgery. However, there is a high risk of procedure related adverse events such as bleeding or perforation (the latter is often unavoidable considering that most SETs are arising from deep wall layers such as the muscularis propria layer).

Endoscopic unroofing is very similar to the mentioned endoscopic resection techniques with the main difference that only partial resection is intended in order to get a representative tissue specimen for histological evaluation. This method has been described in a case series by Lee et al. in 2010 where it showed a very favorable diagnostic yield in gastric SETs [6]. To date, no study has reported on the follow-up of lesions investigated by endoscopic unroofing.

The aim of the present study is to evaluate endoscopic unroofing for small gastric SETs regarding safety, diagnostic yield and potential therapeutic effects over time.

PRIMARY HYPOTHESIS

Endoscopic unroofing has a high diagnostic accuracy in small gastric subepithelial tumors.

METHODS

This retrospective study will be conducted at the Division of Gastroenterology and Hepatology, Department of Internal Medicine III. Of the Medical University of Vienna. Patients who underwent endoscopic unroofing of gastric subepithelial tumors between 2000 and 2015 will be identified by searching the endoscopy reporting database "DOKMON". Clinical data will be collected from patients identified by reviewing endoscopy examination reports as well as other clinical documents including discharge letters in the report archiving database "AKIM". The following parameters will be assessed: Demographics (age, sex), indication for endoscopic unroofing, intraprocedural adverse events, hospital stay, histological result, follow-up procedures (including endoscopic or imaging controls, surgical resection). At the end of the study the mentioned parameters will be presented using descriptive statistics. Data analysis will be performed using SPSS 23.0. All patient related data will be de-identified using pseudonymization prior to any further processing.

SAMPLE SIZE

The investigators expect to encounter approximately 20 patients into this study (between 2000 and 2015).

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Retrospective series of patients treated at a tertiary university based center.

Description

Inclusion criteria:

-) subjects with small gastric subepithelial tumors who underwent endoscopic unroofing

Exclusion criteria:

-) none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 30 days
Peri-interventional adverse events whether related or not
30 days
Diagnostic yield
Time Frame: 1 week
Proportion of study patients with a histologically confirmed diagnosis after endoscopic unroofing.
1 week
Tumor status after endoscopic unroofing
Time Frame: 12 months
Local result during follow up after endoscopic unroofing (proportion of patients with no change vs. partial remission vs. complete remission)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

November 1, 2015

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (ESTIMATE)

October 27, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • EK 1707/2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Small Gastric Subepithelial Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe