Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.

NCT06664307 | Not Yet Recruiting

• 1 other identifier: GPP-USE
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The development of Clinical significant PH (CSPH) is a major driver of complications. PPG is the strongest predictor of decompensation . The shortcomings of GPVH measurements and invasiveness has resulted in an area of unmet clinical need. Non-selective beta-blockers (NSBB) have demonstrated efficacy in reducing PH. However, this requires a second invasive procedure, and there is high interindividual variability in the hemodynamic response to NSBB. EUS-guided GPP measurement emerges as a more accurate, accessible and less invasive technique to potentially predict chronic hemodynamic response. The aim of this project is to assess the safety and efficacy of EUS-derived GPP measurement (EUS-GPP) in patients diagnosed with cirrhosis, to assess the acute hemodynamic response through EUS-derived GPP to intravenous propranolol administration in order to determine the patients who would benefit from NSBB treatment in primary prophylaxis to prevent decompensation using a strategy guided by EUS-GPP measurement.

Conditions

Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS); Hepatic Cirrhosis

Keywords

Portal pressure gradient (PPG), endoscopic ultrasound (EUS) ,.the acute hemodynamic response

Outcome Measures

Primary Outcomes (1)

• - Endoscopic ultrasound with determination of the portal venous pressure gradient using a 25G needle with adapted

  The portal pressure gradient (PPG) is obtained via transgastric, ultrasound-guided intraparenchymal hepatic puncture using a 25G needle (EchoTip Insight, Cook Medical®) equipped with a pressure gauge. Measurements are obtained in mm Hg. A puncture is made in the middle hepatic vein, and three pressure determinations are taken, each lasting one minute. The lowest observed pressure is recorded, and the mean is calculated. Subsequently, the left branch of the portal vein is punctured, and three measurements are taken, each lasting one minute, and their mean is calculated. The PPG is obtained by subtracting the mean pressures in the portal vein from the mean pressures in the hepatic vein. The pressure gauge recording the pressures is always fixed in the same position for all pressure measurements, positioned at the level of the patient's venous axis. After the initial hemodynamic assessment, propranolol (0.15 mg/kg of body weight; aqueous solution of propranolol hydrochloride \[1 mg/ml\] st

  12 months

Study Arms (1)

All patients attending the hepatology clinic or hospitalized with a diagnosis of liver cirrhosis

All patients attending outpatient clinics or hospitalized with a diagnosis of viral etiology or alcohol-related liver cirrhosis will be evaluated for the indication of primary prophylaxis with NSBB according to Baveno VII guidelines. The choice of NSBB type was mainly based on clinical parameters, regardless of the presence of an acute hemodynamic response. In patients who did not show signs of circulatory dysfunction or refractory ascites, carvedilol was preferred, as it has been shown to be more potent in decreasing portal pressure. Carvedilol was initiated at a dose of 6.25 mg/day and, if tolerated, was subsequently increased to a target dose of 12.5 mg/day. Higher doses of carvedilol were only used in cases of concomitant hypertension. For propranolol users, the dose was progressively increased until the heart rate decreased to approximately 55 beats per minute. In patients with significant ascites, a maximum dose of 80 mg/day of propranolol was administered.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients attending the hepatology clinic or hospitalized with a diagnosis of liver cirrhosis and an indication for primary prophylaxis with NSBBs will be prospectively and consecutively included

You may qualify if:

• Patients diagnosed with advanced liver disease with an indication for primary prophylaxis with NSBBs

You may not qualify if:

• \- Age \< 18 years. 2. Advanced stage hepatocellular carcinoma not eligible for curative treatment. 3. Pregnancy. 4. Esophageal stenosis. 5. INR \> 1.5. 6. Platelets \< 50,000 µL. 7. Ascites. 8. Patients with any contraindication for performing an upper gastrointestinal endoscopy.
• \. Patients with contraindication to NSBB treatment. 10. Refusal to sign the informed consent form to participate in the study

Sponsors & Collaborators

• Hospital Universitario Virgen Macarena: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, SEVILLA, 41009, Spain

Location

Related Publications (1)

• Romero-Castro R, Silva-Albarellos E, Grandes-Santamaria L, Carmona-Soria I, Jimenez-Garcia VA, Rodriguez-Tellez M, Caunedo-Alvarez A. Endoscopic ultrasound-guided portal pressure gradient assessment of acute hemodynamic response to intravenous propranolol. Endoscopy. 2026 Mar;58(S 01):E40-E41. doi: 10.1055/a-2764-4494. Epub 2026 Jan 13. No abstract available.

  PMID: 41529708 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• RAFAELR R ROMERO CASTRO, DOCTOR

  SAS

  STUDY DIRECTOR

Central Study Contacts

LOURDES LGS GRANDE SANTAMARIA, DOCTOR

CONTACT

+34 695919735; lourdes.grande.sspa@juntadeandalucia.es

ENRIQUE E SILVA ALBARELLOS, RESIDENTE

CONTACT

+34 622012615

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ESPECIALISTA DE APARATO DIGESTIVO

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 29, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)