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Clinical Trials in Italy / NCT05705557
Recruiting Observational

Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Open Liver Resection

NCT05705557 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2023-01-30
Last updated
2025-08-14

Condition(s) studied

Bile Leak

Investigational drug(s) / intervention(s)

ABSOLOK™ Clip System

ABSOLOK™ Clip System: Use of ABSOLOK™ Clip System during parenchymal transection for open liver resection

Study summary

The purpose of this prospective observational study is to evaluate the incidence of Post-Operative Bile Leakage (POBL) using the ABSOLOK™ Clip System during liver parenchymal resection by evaluating the intraoperative and short-term postoperative results. In addition, it will attempt to determine the factors that determine the surgeon's peripheral glissonian pedicle closure method and economic outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years; * Subject has given his informed consent and signed consent; * Patients undergoing open liver resection. Exclusion Criteria: * Surgery made in emergency; * Surgery by laparoscopy; * Need to perform a bilio-digestive anastomosis; * Preoperative jaundice (total bilirubin \> 3 mg/mL).

Primary outcome measure(s)

  • Incidence of Overall Post-Operative Bile Leakage (POBL) using ABSOLOK™ Clips during liver resection — 90 days
    Participants will be followed for the duration of hospital stay and Follow Up

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma RM Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05705557 on ClinicalTrials.gov ↗ ← All trials in Italy