Neoplasms

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Liver Failure, Acute

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Gastrointestinal Neoplasms

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Liver Extracts

Acetylcysteine

N-monoacetylcystine

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Protective Agents

The allocated organ, in addition to the standard procedure, was treated with a systemic NAC infusion before initiating the liver harvesting procedure, and a loco-regional infusion into the portal vein before cross-clamping.

Allocated organ was treated according to the centre's standard procurement procedure: a modified double perfusion technique, where donor livers are gravity-perfused in situ via the aorta and portal vein with Celsior solution at 4 °C. After hepatectomy, donor livers were further perfused at the back-table with Celsior solution and then stored in conventional bags containing the same solution at 4 °C until transplantation.

15 min systemic NAC infusion of the donor (30 mg/kg, maximum dose 3000 mg) diluted into 500 ml 5 % glucose solution, 30 min before initiating the liver harvesting procedure, and a loco-regional infusion (150 mg/kg of estimated liver weight, maximum dose 300 mg) into the portal vein 5 min before cross-clamping.

N-acetylcystein

Umberto Cillo, MD

Francesco D'Amico, MD

Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).

Anti-oxidant agents have the potential to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT). In this randomized prospective study, we seek to study the impact on the post-LT outcome of the infusion of N-acetylcysteine (NAC) during the liver procurement procedure.

Potential grafts, assigned to adult candidates with chronic liver disease enlisted for first LT, will randomly be included in a one-to-one ratio with a sequential closed envelope single-blinded assignation procedure to either the NAC protocol or in the standard procedure (without NAC).

The NAC protocol comprises: a systemic NAC infusion (30 mg/kg) one hour before the beginning of liver procurement; a loco-regional NAC infusion (300 mg through the portal vein) just before cross-clamping.

Use of N-Acetylcysteine During Liver Procurement

Infusione Sistemica e Loco-regionale di N-Acetilcisteina Nel Prelievo di Fegato: Uno Studio Prospettico Randomizzato Controllato. Fase II.

Azienda Ospedaliera di Padova

Director of the Hepatobiliary Surgery and Liver Transplantation Unit

Inflammation

Hepatitis

Fibrosis

Liver Cirrhosis

Hepatitis A

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.

The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.

This Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:

Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.

Where possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)

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 \[ Phase 1\]

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 \[ Phase 2\]

Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)

number of participants with abnormal levels of liver function tests

number of participants with abnormal non-invasive liver imaging

Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver.

biopsy (Phase 1 and Phase 2)

Boston Scientific Corporation

Sheikh Shakhbout Medical City

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of N-Acetylcysteine During Liver Procurement	NCT01394497	Liver Failure Liver Failure, ... Liver Diseases Carcinoma, Hepa... Liver Neoplasms	N-acetylcystein	18 Years -	Azienda Ospedaliera di Padova
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry	NCT05817994	Liver Diseases Liver Neoplasms Liver Dysfuncti... Liver Failure, ... Liver Fibrosis Liver Inflammat...		-	Sheikh Shakhbout Medical City

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