An interventional study of DFI-EUS and CE-EUS in Leiomyoma and GIST, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Not applicable, Interventional, and Diagnostic
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.
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.
438 studies on the registry are indexed under Leiomyoma; 74 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 306 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: DFI-EUS · Diagnostic Test: CE-EUS
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.
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.
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.
Time frame: 1 day
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.
Time frame: Up to 1 year
Started Jul 2022 (actual). Primary completion is estimated for Jan 2024, 18 months after the start.
Of 52 non-industry interventional studies with no phase under Leiomyoma, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 57 studies reached it within 31 months; a quarter within 15 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto Ecuatoriano de Enfermedades Digestivas