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Detective Flow Imaging Endoscopic Ultrasonography in Subepithelial Lesions

Primary Purpose

Leiomyoma, GIST

Status
Recruiting
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
DFI-EUS
CE-EUS
Sponsored by
Instituto Ecuatoriano de Enfermedades Digestivas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Leiomyoma focused on measuring Subepithelial lesion, detective flow imaging, Endoscopic Ultrasound-Guided Fine Needle Aspiration

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients referred to our center with an indication of EUS for the evaluation of SELs
  • Patients who authorized for DFI or CE-EUS.
  • Written informed consent

Exclusion Criteria:

  • Patients with contraindication for contrast agent administration.
  • Any clinical condition which makes EUS-DFI or CE-EUS inviable
  • Pregnancy

Sites / Locations

  • Instituto Ecuatoriano de Enfermedades Digestivas (IECED)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subepithelial lesions

Arm Description

Patients with subepithelial lesions of the gastrointestinal (GI) tract (GISTs or leiomyomas) at EUS evaluation. Two interventions: EUS-DFI examination for the detection of slow flow vascularization in SELS. Then, CE-EUS for diagnosis confirmation.

Outcomes

Primary Outcome Measures

Diagnostic yield of DFI-EUS in the identification of SELs
DFI effectiveness in the detection of vascularity in SELs will be assessed by the rates of identification of the intratumoral vessels. when compared with CE-EUS. Data from DFI and CE-EUS will be presented through a 2 x 2 contingency table.
Sensitivity and Specificity of DFI-EUS in the diagnosis of SELS
Evaluate the sensitivity and specificity of DFI-EUS in the diagnosis of SELS. Data will be presented in percentages.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2022
Last Updated
September 26, 2023
Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas
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1. Study Identification

Unique Protocol Identification Number
NCT05474794
Brief Title
Detective Flow Imaging Endoscopic Ultrasonography in Subepithelial Lesions
Official Title
Diagnosis of Gastrointestinal Subepithelial Lesions Using a Novel Endoscopic Ultrasonography Imaging Technique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2022 (Actual)
Primary Completion Date
January 20, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Ecuatoriano de Enfermedades Digestivas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Gastrointestinal stromal tumors (GIST) are the most common malignant subepithelial lesions (SELs) found in the gastrointestinal tract. The diagnosis and differentiation of these lesions from other subepithelial hypoechogenic tumors (i.e.as leiomyoma), is important as this may have an impact in the prognosis and treatment of either. Due to GIST's notable features (vascularity and deep location), endoscopic ultrasound (EUS) is the first-line diagnostic approach. Based on this, three models (color-doppler EUS, power-doppler EUS, and e-FLOW EUS), are useful for real-time vascularity detection; however, these modalities are not helpful for fine and slow flow vessel detection. For overcoming this limitation, contrast-enhanced EUS (CE-EUS) is proposed as a first-line approach. Nevertheless, the use of contrast may be harmful, thus limited to some patients. To avoid contrast-related adverse events, a novel diagnostic method known as detective flow imaging endoscopic ultrasonography (DFI-EUS) has emerged. This technique detects fine vessels and slow flow without contrast. Despite the advantages of the latter, few studies have compared it with other diagnostic approaches in the evaluation and differentiation of SELs. Hence, the investigators aim to evaluate the utility of DFI-EUS in the diagnosis of SELs (GIST and leiomyoma) by comparing it with CE-EUS.
Detailed Description
Subepithelial lesions (SELs) are a frequent finding on routine endoscopy (0.2%-3%), The importance of its diagnosis and management is based on its high risk of malignant transformation. According to literature, gastrointestinal stromal tumors (GIST) are the most common malignant SELs of the gastrointestinal tract. GIST appear as subepithelial lesions often covered by normal mucosa. For prognosis and treatment purposes, GIST should be differentiated from other benign submucosal hypoechogenic lesions such as leiomyoma, slow growing tumors, located preponderantly in the esophagus. The differential diagnosis between GISTs and leiomyoma is challenging because both can rise from the same second and forth muscular layers (muscularis mucosae and muscularis propria) and important because of the malignant potential of the former and consequently different management approach. GISTs' diagnosis is approached by a combination of clinical signs and symptoms, laboratory tests and imaging techniques. Endoscopic techniques, such as esophagogastroduodenoscopy (EGD), is not useful to delineate the depth of invasion or subepithelial appearance of the lesions; also, conventional tissue acquisition through this modality is difficult when the tumor is not ulcerated. Due to this, EUS is considered critical for an accurate diagnosis, being the first-line diagnostic approach. To date, color- doppler EUS, power doppler EUS, and e-FLOW EUS are EUS technologies that may be useful for observing vascularity in real time, but not for proper visualization of fine vessels and slow flow. On the other hand, contrast-enhanced EUS (CE-EUS) increases the detectability of vessels with high sensitivity yet holding the risk and limitations inherent to contrast administration. To overcome diagnostic limitations, a new diagnostic method known as detective flow imaging endoscopic ultrasonography (DFI-EUS) has emerged. DFI-EUS detects fine vessels and low-velocity blood flow without the use of contrast agents. Despite its promising benefits, few studies have evaluated its advantages for the diagnosis and differentiation of GISTs. Only two studies have compared this technology against e-FLOW EUS, but in pancreatic tissue. In the present study the investigators aim to evaluate the utility of DFI-EUS in the diagnosis of SELs (GIST and leiomyoma) by comparing it with CE-EUS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma, GIST
Keywords
Subepithelial lesion, detective flow imaging, Endoscopic Ultrasound-Guided Fine Needle Aspiration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment A non-blinded, single center, non-randomized prospective, case control study
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subepithelial lesions
Arm Type
Experimental
Arm Description
Patients with subepithelial lesions of the gastrointestinal (GI) tract (GISTs or leiomyomas) at EUS evaluation. Two interventions: EUS-DFI examination for the detection of slow flow vascularization in SELS. Then, CE-EUS for diagnosis confirmation.
Intervention Type
Diagnostic Test
Intervention Name(s)
DFI-EUS
Intervention Description
All patients enrolled having a confirmed histologic diagnosis of GIST or leiomyoma will undergo endoscopic ultrasound evaluation. First, the expert endoscopist will perform EUS-DFI examination for the detection of slow flow vascularization in SELS. Microvascularization EUS-Doppler evaluation will last between three and five minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
CE-EUS
Intervention Description
Immediately, after the first approach, CE-EUS (using Sulphur hexafluoride ultrasound contrast agent) will be performed for diagnosis confirmation. Sonovue will be administered intravenously in one (2.4 mL) or two administrations (4.8 ml), according to physician´s criteria, followed by an injected flush of 5 mL of sodium chloride solution (9 mg/mL). CE-EUS it will take around 5 minutes, with a total diagnostic approach around one hour.
Primary Outcome Measure Information:
Title
Diagnostic yield of DFI-EUS in the identification of SELs
Description
DFI effectiveness in the detection of vascularity in SELs will be assessed by the rates of identification of the intratumoral vessels. when compared with CE-EUS. Data from DFI and CE-EUS will be presented through a 2 x 2 contingency table.
Time Frame
1 day
Title
Sensitivity and Specificity of DFI-EUS in the diagnosis of SELS
Description
Evaluate the sensitivity and specificity of DFI-EUS in the diagnosis of SELS. Data will be presented in percentages.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred to our center with an indication of EUS for the evaluation of SELs Patients who authorized for DFI or CE-EUS. Written informed consent Exclusion Criteria: Patients with contraindication for contrast agent administration. Any clinical condition which makes EUS-DFI or CE-EUS inviable Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Robles-Medranda, MD FASGE
Phone
+59342109180
Email
carlosoakm@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD FASGE
Organizational Affiliation
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
City
Guayaquil
State/Province
Guayas
ZIP/Postal Code
090505
Country
Ecuador
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Robles-Medranda, MD FASGE
Phone
+59342109180
Email
carlosoakm@yahoo.es

12. IPD Sharing Statement

Citations:
PubMed Identifier
33145842
Citation
Yamashita Y, Yoshikawa T, Kawaji Y, Tamura T, Hatamaru K, Itonaga M, Ida Y, Maekita T, Iguchi M, Murata SI, Kitano M. Novel endoscopic ultrasonography imaging technique for visualizing microcirculation without contrast enhancement in subepithelial lesions: Prospective study. Dig Endosc. 2021 Sep;33(6):955-961. doi: 10.1111/den.13889. Epub 2020 Dec 23.
Results Reference
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PubMed Identifier
34829364
Citation
Yamashita Y, Yoshikawa T, Yamazaki H, Kawaji Y, Tamura T, Hatamaru K, Itonaga M, Ashida R, Ida Y, Maekita T, Iguchi M, Kitano M. A Novel Endoscopic Ultrasonography Imaging Technique for Depicting Microcirculation in Pancreatobiliary Lesions without the Need for Contrast-Enhancement: A Prospective Exploratory Study. Diagnostics (Basel). 2021 Oct 30;11(11):2018. doi: 10.3390/diagnostics11112018.
Results Reference
background
PubMed Identifier
34560242
Citation
Casali PG, Blay JY, Abecassis N, Bajpai J, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Boye K, Brodowicz T, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dufresne A, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Frezza AM, Gasperoni S, Gelderblom H, Gouin F, Grignani G, Haas R, Hassan AB, Hindi N, Hohenberger P, Joensuu H, Jones RL, Jungels C, Jutte P, Kasper B, Kawai A, Kopeckova K, Krakorova DA, Le Cesne A, Le Grange F, Legius E, Leithner A, Lopez-Pousa A, Martin-Broto J, Merimsky O, Messiou C, Miah AB, Mir O, Montemurro M, Morosi C, Palmerini E, Pantaleo MA, Piana R, Piperno-Neumann S, Reichardt P, Rutkowski P, Safwat AA, Sangalli C, Sbaraglia M, Scheipl S, Schoffski P, Sleijfer S, Strauss D, Strauss SJ, Hall KS, Trama A, Unk M, van de Sande MAJ, van der Graaf WTA, van Houdt WJ, Frebourg T, Gronchi A, Stacchiotti S; ESMO Guidelines Committee, EURACAN and GENTURIS. Electronic address: clinicalguidelines@esmo.org. Gastrointestinal stromal tumours: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2022 Jan;33(1):20-33. doi: 10.1016/j.annonc.2021.09.005. Epub 2021 Sep 21. No abstract available.
Results Reference
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Detective Flow Imaging Endoscopic Ultrasonography in Subepithelial Lesions

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