ABSOLOK™ clip system for preventing bile leaks after open liver resection
Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection
This will try the ABSOLOK™ clip system during open liver surgery to see if it reduces post-operative bile leaks in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05705557 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study that records intraoperative and short-term postoperative outcomes when surgeons use the ABSOLOK™ Clip System during open liver parenchymal resection. The primary measure is the incidence of post-operative bile leakage defined by ISGLS criteria, with additional capture of clinically relevant leaks and related complications. The study also collects data on the factors influencing the surgeon's choice of peripheral Glissonian pedicle closure method and on economic outcomes. Patients are adults undergoing planned open hepatectomy and exclude emergency or laparoscopic cases, those needing bilio-digestive anastomosis, or with preoperative bilirubin >3 mg/dL.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for planned open liver resection and can provide informed consent are eligible.
Not a fit: Patients having emergency or laparoscopic surgery, those requiring a bilio-digestive anastomosis, or with preoperative jaundice (total bilirubin >3 mg/dL) are not expected to benefit from this protocol.
Why it matters
Potential benefit: If successful, using the ABSOLOK™ clip system could reduce post-hepatectomy bile leak rates and related complications, shortening hospital stay.
How similar studies have performed: Large retrospective series have documented a meaningful rate of post-operative bile leakage after hepatectomy and higher rates with open versus laparoscopic approaches, but prospective evidence specifically on ABSOLOK™ use is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Felice Giulante, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Felice Giuliante, MD
- Email: felice.giuliante@policlinicogemelli.it
- Phone: +39 0630156857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.