RecruitingNCT05705557

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

Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

180 participants

Start Date

Jan 30, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥ 18 years;
  • Subject has given his informed consent and signed consent;
  • Patients undergoing open liver resection.

Exclusion Criteria4

  • Surgery made in emergency;
  • Surgery by laparoscopy;
  • Need to perform a bilio-digestive anastomosis;
  • Preoperative jaundice (total bilirubin > 3 mg/mL).

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Interventions

DEVICEABSOLOK™ Clip System

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


Locations(1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, Italy

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NCT05705557


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