Estimation of Liver Fibrosis in Patients With MASLD Screening Criteria Through Endoscopic Ultrasound-guided Shear Wave vs Transabdominal Ultrasound and Transient Elastography: The RUMIPAMBA Diagnostic Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Currently, there is no description of the contribution of the endoscopic ultrasound (EUS)-guided shear wave elastography (SWE) when describing liver fibrosis in patients with screening criteria of metabolic dysfunction-associated steatotic liver disease (MASLD), with absent-to-mild liver fibrosis. Similar research has been published but using vibration-controlled transient elastography (VCTE), recommended mainly due to its lower cost and less invasiveness. However, VCTE is limited to the anatomical proportions of the patient's body, and cannot assess the right hepatic lobe with less reliability, contrary to the EUS-SWE.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Patients referred for any kind of endoscopic procedure.

• Without clinical suspicion of advanced liver fibrosis.

• Acceptance to participate in the study.

Locations
Other Locations
Ecuador
Instituto Ecuatoriano de Enfermedades Digestivas (IECED) Gastroclinica SA
RECRUITING
Guayaquil
Contact Information
Primary
Miguel Puga-Tejada, MD
mpuga@ieced.ec
+353 87 686 0537
Backup
Jorge Baquerizo-Burgos, MD
jorgebaquerizoburgos@gmail.com
+593 98 962 7111
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 30
Treatments
Active_comparator: MASLD screening patients
Patients with requirements of screening following the European Association for the Study of the Liver (EASL) 2016 recommendations. The MASLD screening group will be compounded by patients with at least one of the following criteria:~1. Over fifty years old;~2. Body mass index (BMI) over 25 kg/m2;~3. Diabetes mellitus type 2;~4. Metabolic syndrome; or~5. Persistently elevated liver enzymes.
Other: Controls
Patients without requirements of screening following the European Association for the Study of the Liver (EASL) 2016 recommendations. The control group will be compounded by patients who will not present any of the following criteria:~1. Over fifty years old;~2. Body mass index (BMI) over 25 kg/m2;~3. Diabetes mellitus type 2;~4. Metabolic syndrome; and~5. Persistently elevated liver enzymes.~To be a control participant does not mean that the patient is a healthy participant. The control participants are patients who request any type of endoscopy and fulfil the criteria not to screen for liver steatosis. For example, a 48-year-old male with 21 kg/m2 BMI, without diabetes mellitus type 2, any metabolic syndrome-related comorbidities, with normal liver enzymes and who refused an episode of persistently elevated liver enzymes, with persistent reflux disease after two months of proton pump inhibitor therapy,
Sponsors
Leads: Instituto Ecuatoriano de Enfermedades Digestivas

This content was sourced from clinicaltrials.gov