Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Open Liver Resection
ConditionBile Leak
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
Qualifiers
Age ≥ 18 years;
Subject has given his informed consent and signed consent;
Patients undergoing open liver resection.
Disqualifiers
Surgery made in emergency;
Surgery by laparoscopy;
Need to perform a bilio-digestive anastomosis;
Preoperative jaundice (total bilirubin > 3 mg/mL).
Trial design
Treatments tested in this trial
- ABSOLOK™ Clip System
Treatment groups
180 Participants
are divided into 1 treatment groupSponsors and collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Ethicon, Inc.
Collaborator
Source ClinicalTrials.gov