Clinical trial · Observational
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry
Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)
NCT05817994CI-TRIAL-00082709REGALwithdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was withdrawn by the sponsor
Summary
Brief summary (as posted)
Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic\_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Diseases | — | UNRESOLVED | — |
| Liver Dysfunction | — | UNRESOLVED | — |
| Liver Failure, Acute | — | UNRESOLVED | — |
| Liver Fibrosis | — | UNRESOLVED | — |
| Liver Inflammation | — | UNRESOLVED | — |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]
- timeFrame
- 30 Days in Phase 1
- description
- Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \[ Phase 1\]
- measure
- Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]
- timeFrame
- 12 months in phase 2
- description
- Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \[ Phase 2\]
Secondary outcomes (4)
- measure
- Number of serious adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Adult (per local age threshold) * Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver * Planned upper endoscopy to evaluate for varices * Planned liver biopsy based on suspected hepatitis or cirrhosis Exclusion Criteria: * Severe Coagulation/bleeding disorder as defined by INR \> 2 IU which cannot be corrected with FFP or Platelets \< 50,000 per microliter which cannot be corrected with platelet transfusion. * Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5) * Inability to provide informed consent
References
Publications (9)
- BACKGROUNDAsrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26. PMID 30266282
- BACKGROUNDMorales-Ruiz, Manuel, et al.
- BACKGROUNDBaran B, Kale S, Patil P, Kannadath B, Ramireddy S, Badillo R, DaVee RT, Thosani N. Endoscopic ultrasound-guided parenchymal liver biopsy: a systematic review and meta-analysis. Surg Endosc. 2021 Oct;35(10):5546-5557. doi: 10.1007/s00464-020-08053-x. Epub 2020 Oct 14. PMID 33052529
- BACKGROUNDAli AH, Panchal S, Rao DS, Gan Y, Al-Juboori A, Samiullah S, Ibdah JA, Hammoud GM. The efficacy and safety of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy in patients with chronic liver disease: a retrospective single-center study. J Ultrasound. 2020 Jun;23(2):157-167. doi: 10.1007/s40477-020-00436-z. Epub 2020 Mar 5. PMID 32141043
- BACKGROUNDBang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available. PMID 33766911
- BACKGROUNDASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available. PMID 28320514
- BACKGROUNDSamarasena JB, Chang KJ. Endoscopic Ultrasound-Guided Portal Pressure Measurement and Interventions. Clin Endosc. 2018 May;51(3):222-228. doi: 10.5946/ce.2018.079. Epub 2018 May 31. PMID 29874904