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NCT06216509: EUSPREM
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
NA trial testing Endoscopic ultrasound pressure measurement in Cirrhosis in 50 participants. Completed in 20 December 2024.
20 November 2024
Quick facts
| Lead sponsor | Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 10 January 2023 |
| Primary completion | 20 November 2024 |
| Estimated completion | 20 December 2024 |
| Sites | 1 location across Romania |
Drugs / interventions tested
- Endoscopic ultrasound pressure measurement
Conditions studied
- Cirrhosis — all drugs for Cirrhosis →
- Vascular Diseases — all drugs for Vascular Diseases →
Sponsor
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Who can join
Adults 18 to 85, any sex, with Cirrhosis or Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Portal hypertension (PHT) is the main consequence of advanced chronic liver diseases (ACLD) and is often associated with severe complications leading to increased morbidity and mortality. Currently, the gold standard for the evaluation of the severity of PHT is the hepatic venous-pressure gradient (HVPG). The disadvantage of using the HVPG, besides the availability of the technique only in referral centres, is in the case of patients with vascular liver disorders because the HVPG underestimates the severity of PHT. Recent studies have evaluated the feasibility of the pressure gradient measurement through endoscopic transgastric and transhepatic access using special kit with a 25-gauge FNA needle (Cook Medical, Winston-Salem, NC, USA) and a compact manometer (Cook Medical, Bloomington, Ind, USA) that has the disadvantage of high purchase cost, no tracing of pressure possible and has not yet been properly correlated with the gold standard HVPG measurement or PPG measurement thus limiting its use in current practice. The aim of the study is 1. to assess and compare the correlations in the porto-systemic gradient measurement between a) direct portal vein puncture during TIPS insertion, b) direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound procedure and c) indirect portal vein pressure measurements using the interventional radiology based hepatic HVPG procedure in patients with cirrhosis submitted to TIPS procedure for complications of portal hypertension and 2. To evaluate and compare the porto-systemic gradient obtained by direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound and indirect measurement through HVPG measuring in patients with presinusoidal hypertension and those with portal vein thrombosis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Endoscopic ultrasound versus direct transjugular portal pressure gradient in patients receiving TIPS: influence of portal vein thrombosis.
Dragomir I, Pojoga C, Hagiu C, Bolboacă SD, et al · · 2026 · PMID 42221556 · DOI 10.1093/gastro/goag052
Verify or expand the search:
- PubMed search for NCT06216509
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor trials
Trials by the same sponsor.
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- NCT05418543 — CH-EUS in Diagnosis of Inoperable Bile Duct Tumors · NA · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06216509 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
- Last refreshed: 25 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06216509.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing