Bile Leak Clinical Trial
— EBILROKOfficial title:
Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection
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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | November 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Ethicon, Inc. |
Italy,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Overall Post-Operative Bile Leakage (POBL) using ABSOLOK™ Clips during liver resection | Participants will be followed for the duration of hospital stay and Follow Up | 90 days | |
Secondary | Duration of POBL (Post-operative bile leakage) and the timing of drainage removal | Participants will be followed for the duration of hospital stay and Follow Up | 90 days | |
Secondary | Additional maneuvers for treat biliary fistula | Participants will be followed for the duration of hospital stay and Follow Up | 90 days | |
Secondary | Lenght of post-operative stay | Participants will be followed for the duration of hospital stay | 90 days | |
Secondary | Rate of post-operative Morbidity | Participants will be followed for the duration of hospital stay and Follow Up | 90 days | |
Secondary | Rate of post-operative Mortality | 90 days |
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