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Small Gastric Subepithelial TumorNCT02587923

Endoscopic Unroofing for Small Gastric SETs

An observational study of Small Gastric Subepithelial Tumor, run by Medical University of Vienna.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Small Gastric Subepithelial Tumor
How many people
20 participants
Where
No sites listed yet
Study dates
Oct 2015to Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • -) none

Trial locations and contacts

No sites are listed yet.

About this study

Official title: 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.

Read the 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Peri-interventional adverse events whether related or not

    Measured: 30 days

  2. Diagnostic yield

    Proportion of study patients with a histologically confirmed diagnosis after endoscopic unroofing.

    Measured: 1 week

  3. Tumor status after endoscopic unroofing

    Local result during follow up after endoscopic unroofing (proportion of patients with no change vs. partial remission vs. complete remission)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2015 (estimated)
  4. Study completionNov 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587923
Sponsor's protocol ID
EK 1707/2015
Status last verified
Oct 2015
First submitted
23 Oct 2015
Last updated
27 Oct 2015
Results posted
No

Publications

  • Iorio N, Sawaya RA, Friedenberg FK. Review article: the biology, diagnosis and management of gastrointestinal stromal tumours. Aliment Pharmacol Ther. 2014 Jun;39(12):1376-86. doi: 10.1111/apt.12761. Epub 2014 Apr 20.

    PubMed 24749828
  • Buscaglia JM, Nagula S, Jayaraman V, Robbins DH, Vadada D, Gross SA, DiMaio CJ, Pais S, Patel K, Sejpal DV, Kim MK. Diagnostic yield and safety of jumbo biopsy forceps in patients with subepithelial lesions of the upper and lower GI tract. Gastrointest Endosc. 2012 Jun;75(6):1147-52. doi: 10.1016/j.gie.2012.01.032. Epub 2012 Mar 15.

    PubMed 22425270
  • Watson RR, Binmoeller KF, Hamerski CM, Shergill AK, Shaw RE, Jaffee IM, Stewart L, Shah JN. Yield and performance characteristics of endoscopic ultrasound-guided fine needle aspiration for diagnosing upper GI tract stromal tumors. Dig Dis Sci. 2011 Jun;56(6):1757-62. doi: 10.1007/s10620-011-1646-6. Epub 2011 Mar 1.

    PubMed 21360279
  • Zhou PH, Yao LQ, Qin XY, Cai MY, Xu MD, Zhong YS, Chen WF, Zhang YQ, Qin WZ, Hu JW, Liu JZ. Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surg Endosc. 2011 Sep;25(9):2926-31. doi: 10.1007/s00464-011-1644-y. Epub 2011 Mar 18.

    PubMed 21424195
  • Wilhelm D, von Delius S, Burian M, Schneider A, Frimberger E, Meining A, Feussner H. Simultaneous use of laparoscopy and endoscopy for minimally invasive resection of gastric subepithelial masses - analysis of 93 interventions. World J Surg. 2008 Jun;32(6):1021-8. doi: 10.1007/s00268-008-9492-1.

    PubMed 18338207
  • Lee CK, Chung IK, Lee SH, Lee SH, Lee TH, Park SH, Kim HS, Kim SJ, Cho HD. Endoscopic partial resection with the unroofing technique for reliable tissue diagnosis of upper GI subepithelial tumors originating from the muscularis propria on EUS (with video). Gastrointest Endosc. 2010 Jan;71(1):188-94. doi: 10.1016/j.gie.2009.07.029. Epub 2009 Oct 30.

    PubMed 19879567
  • Dolak W, Beer A, Kristo I, Tribl B, Asari R, Schoniger-Hekele M, Wrba F, Schoppmann SF, Trauner M, Puspok A. A retrospective study on the safety, diagnostic yield, and therapeutic effects of endoscopic unroofing for small gastric subepithelial tumors. Gastrointest Endosc. 2016 Dec;84(6):924-929. doi: 10.1016/j.gie.2016.04.019. Epub 2016 Apr 22.

    PubMed 27109457

Questions about this trial

What is this clinical trial studying?

An observational study of Small Gastric Subepithelial Tumor, run by Medical University of Vienna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Werner Dolak, MD (+43140400 ext. 65890, werner.dolak@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587923, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.

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