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

August 11, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Over the last two decades, significant advances have been made in hepatectomy because of advancements in surgical techniques and improvement on parenchymal transection. Modern liver surgeon must be equipped with excellent theoretical and clinical skills to perform a safe liver resection. Despite significant technical advancements in the field of liver surgery, bile leakage remains a significant postoperative morbidity. Although the exact post-hepatectomy bile leakage site is not clear, bile leakage reportedly occurs in 3-12% according to the kind of resection.

Recently, in a large multicenter retrospective series, including 13.379 resected patients, the overall incidence of post-operative bile leakage (POBL) is 6%, significantly higher after open versus laparoscopic approach, respectively 9,4% vs 3,1% (p<0.001). POBL was defined according to the 2010 International Study Group of Liver Surgery (ISGLS) and it was categorized in three grades of severity (grade A, B, C) and clinically relevant POBL (CR-POBL) was defined as grade B and C. CR-POBL is associated with increased length of post-operative stay and can be associated with subsequent severe complications such as intra-abdominal abscess, peritonitis, and sepsis. In the case of anatomical liver resection, most of the leakage points are observed around the hilar Glissonean stump and not at the peripheral parenchymal cutting plane, because parenchymal resection is usually performed along the intersegmental plane.

Recently, parenchyma-sparing hepatectomy (PSH) has become a gold standard treatment for colorectal liver metastases (CLM). PSH is associated with better perioperative outcomes without compromising oncological outcomes and given the relatively high incidence of hepatic parenchymal recurrence, the PSH treatment offers a greater opportunity of repeat resection for intrahepatic recurrences.

Anatomic resection (AR) remains the gold standard surgical treatment for hepatocellular carcinoma (HCC) in patients with a well-preserved liver function because postoperative recurrence is usually caused by micrometastases around the tumor therefore resecting the tumor-bearing portal branches and the corresponding liver parenchyma achieving better local control. US-guided limited resection (LR) and AR may be chosen and/or combined by the surgeon for the other surgical indications. Most of the leakage points are observed at the peripheral parenchymal cutting plane despite the liver parenchymal transection was carried out using the ultrasonic dissector and all peripheral glissonian pedicles (≥ 2-3 mm) were separately isolated, clipped or ligated and transected.

The aim of the prospective study is to assess the incidence of POBL using ABSOLOK™ Clip System during parenchymal liver transection, evaluating intra-operative and short-term post-operative results. In addition, the factors that determine the surgeon's peripheral glissonian pedicle closure method and cost results will be tried to be determined.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Roma, RM, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • Contact:
        • Principal Investigator:
          • Felice Giuliante, MD
        • Sub-Investigator:
          • Francesco Ardito, MD, PhD
        • Sub-Investigator:
          • Agostino Maria De Rose, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing laparotomic (open) liver resection or re-resection for any underlying disease. The list of underlying diseases is the following (but might not be limited to):

  • Colorectal liver metastases;
  • Liver metastases from other primary malignancy (Breast, Ovarian, Neuroendocrine Tumors, Adrenal, Non-neuroendocrine Tumors, Other);
  • Intrahepatic Cholangiocarcinoma;
  • Gallbladder Cancer;
  • Hepatocellular Carcinoma;
  • Benign Tumors (Hepatic Adenoma, Haemangioma, Focal nodular hyperplasia);
  • Intrahepatic Bile Duct dilation and/or intrahepatic lithiasis;
  • Hidatid Cyst.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OPEN Liver Resection
Patients undergoing laparotomic (OPEN) Liver Resection
Device: ABSOLOK™ Clip System
Use of ABSOLOK™ Clip System during parenchymal transection for open liver resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Overall Post-Operative Bile Leakage (POBL) using ABSOLOK™ Clips during liver resection
Time Frame: 90 days
Participants will be followed for the duration of hospital stay and Follow Up
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of POBL (Post-operative bile leakage) and the timing of drainage removal
Time Frame: 90 days
Participants will be followed for the duration of hospital stay and Follow Up
90 days
Additional maneuvers for treat biliary fistula
Time Frame: 90 days
Participants will be followed for the duration of hospital stay and Follow Up
90 days
Lenght of post-operative stay
Time Frame: 90 days
Participants will be followed for the duration of hospital stay
90 days
Rate of post-operative Morbidity
Time Frame: 90 days
Participants will be followed for the duration of hospital stay and Follow Up
90 days
Rate of post-operative Mortality
Time Frame: 90 days
Assessment of mortality during the hospitalization or Follow Up
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Felice Giulante, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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