Health TrialsbyHealthPanel

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

ConditionBile Leak
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Subject has given his informed consent and signed consent;

Patients undergoing open liver resection.

Disqualifiers

Surgery made in emergency;

Surgery by laparoscopy;

Need to perform a bilio-digestive anastomosis;

Preoperative jaundice (total bilirubin > 3 mg/mL).

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • ABSOLOK™ Clip System

    Device

    Use of ABSOLOK™ Clip System during parenchymal transection for open liver resection

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: OPEN Liver Resection1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
90 days

Secondary outcomes

1

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

Time frame
90 days
2

Additional maneuvers for treat biliary fistula

Participants will be followed for the duration of hospital stay and Follow Up

Time frame
90 days
3

Lenght of post-operative stay

Participants will be followed for the duration of hospital stay

Time frame
90 days
4

Rate of post-operative Morbidity

Participants will be followed for the duration of hospital stay and Follow Up

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Ethicon, Inc.

Collaborator

Source ClinicalTrials.gov
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