ABSOLOK™ clip system for preventing bile leaks after open liver resection
Official title: Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05705557 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | January 30, 2023 |
| Main results expected | December 2025 |
| Study ends | March 2026 |
| Registry record updated | August 14, 2025 |
| Trial ID | NCT05705557 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who are scheduled for planned open liver resection and can provide informed consent are eligible.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing two surgical techniques for bile duct connection in liver transplantation
This study is testing two different surgical methods for connecting bile ducts during liver transplants to see which one leads to fewer complications and better recovery for patients.
-
How cinema sessions during chemotherapy might help cervical cancer patients
We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.
-
Ophthalmic Artery Doppler to predict labor problems before induction
This study tests whether measuring the ophthalmic artery Doppler in pregnant people at term who are being induced can help predict intrapartum fetal distress.
-
GCP-R3 Practice Survey for Italian Clinical Researchers
Researchers in Italy are taking a web survey to see how well they understand and apply GCP E6(R3) and to identify barriers and training needs.
-
Longitudinal profiling of plasma-derived glial extracellular vesicles in Alzheimer's disease
This study tests whether plasma glial extracellular vesicles and neuroinflammation biomarkers change over time across the Alzheimer’s disease spectrum and whether these signals relate to amyloid, tau, and neurodegeneration, with an additional step of exposing healthy iPSC-derived neurons to vesicles to see potential ne
-
Amniotic Fluid DNA sequencing to detect infection in women with short cervix or PROM
This study tests a nanopore DNA sequencing method on amniotic fluid to see if it more reliably detects infection and inflammation than standard bacterial cultures in pregnant women with short cervix or premature rupture of membranes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.