Clinical trial NCT05705557: Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bile Leak
Keywords: Liver resection
Hepatectomy
Absolok
Bile Leak
Laparotomy
Open Liver resection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2023-01-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility 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).

Primary outcomes:
measure: Incidence of Overall Post-Operative Bile Leakage (POBL) using ABSOLOK™ Clips during liver resection
timeFrame: 90 days
Secondary outcomes:
measure: Duration of POBL (Post-operative bile leakage) and the timing of drainage removal
timeFrame: 90 days
measure: Additional maneuvers for treat biliary fistula
timeFrame: 90 days
measure: Lenght of post-operative stay
timeFrame: 90 days
measure: Rate of post-operative Morbidity
timeFrame: 90 days
measure: Rate of post-operative Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: RM
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Felice Giulante, MD
role: PRINCIPAL_INVESTIGATOR
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