NCT05705557

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

August 14, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

January 20, 2023

Last Update Submit

August 11, 2025

Conditions

Bile Leak

Keywords

Liver resectionHepatectomyAbsolokBile LeakLaparotomyOpen Liver resection

Outcome Measures

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

    90 days

Secondary Outcomes (5)

  • Duration of POBL (Post-operative bile leakage) and the timing of drainage removal

    90 days

  • Additional maneuvers for treat biliary fistula

    90 days

  • Lenght of post-operative stay

    90 days

  • Rate of post-operative Morbidity

    90 days

  • Rate of post-operative Mortality

    90 days

Study Arms (1)

OPEN Liver Resection

Patients undergoing laparotomic (OPEN) Liver Resection

Device: ABSOLOK™ Clip System

Interventions

ABSOLOK™ Clip SystemDEVICE

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

OPEN Liver Resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Age ≥ 18 years;
  • Subject has given his informed consent and signed consent;
  • Patients undergoing open liver resection.

You may not qualify if:

  • Surgery made in emergency;
  • Surgery by laparoscopy;
  • Need to perform a bilio-digestive anastomosis;
  • Preoperative jaundice (total bilirubin \> 3 mg/mL).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

Related Publications (13)

  • Torzilli G, McCormack L, Pawlik T. Parenchyma-sparing liver resections. Int J Surg. 2020 Oct;82S:192-197. doi: 10.1016/j.ijsu.2020.04.047. Epub 2020 Apr 23.

    PMID: 32335245BACKGROUND

  • Martin AN, Narayanan S, Turrentine FE, Bauer TW, Adams RB, Stukenborg GJ, Zaydfudim VM. Clinical Factors and Postoperative Impact of Bile Leak After Liver Resection. J Gastrointest Surg. 2018 Apr;22(4):661-667. doi: 10.1007/s11605-017-3650-4. Epub 2017 Dec 15.

    PMID: 29247421BACKGROUND

  • Brooke-Smith M, Figueras J, Ullah S, Rees M, Vauthey JN, Hugh TJ, Garden OJ, Fan ST, Crawford M, Makuuchi M, Yokoyama Y, Buchler M, Weitz J, Padbury R. Prospective evaluation of the International Study Group for Liver Surgery definition of bile leak after a liver resection and the role of routine operative drainage: an international multicentre study. HPB (Oxford). 2015 Jan;17(1):46-51. doi: 10.1111/hpb.12322. Epub 2014 Jul 24.

    PMID: 25059275BACKGROUND

  • Gorgec B, Cacciaguerra AB, Aldrighetti LA, Ferrero A, Cillo U, Edwin B, Vivarelli M, Lopez-Ben S, Besselink MG, Abu Hilal M; International Study Group of Bile Leakage after Liver Surgery. Incidence and Clinical Impact of Bile Leakage after Laparoscopic and Open Liver Resection: An International Multicenter Propensity Score-Matched Study of 13,379 Patients. J Am Coll Surg. 2022 Feb 1;234(2):99-112. doi: 10.1097/XCS.0000000000000039.

    PMID: 35213428BACKGROUND

  • Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, Fan ST, Yokoyama Y, Crawford M, Makuuchi M, Christophi C, Banting S, Brooke-Smith M, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Nimura Y, Figueras J, DeMatteo RP, Buchler MW, Weitz J. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011 May;149(5):680-8. doi: 10.1016/j.surg.2010.12.002. Epub 2011 Feb 12.

    PMID: 21316725BACKGROUND

  • Deng G, Li H, Jia GQ, Fang D, Tang YY, Xie J, Chen KF, Chen ZY. Parenchymal-sparing versus extended hepatectomy for colorectal liver metastases: A systematic review and meta-analysis. Cancer Med. 2019 Oct;8(14):6165-6175. doi: 10.1002/cam4.2515. Epub 2019 Aug 28.

    PMID: 31464101BACKGROUND

  • Sun Z, Li Z, Shi XL, He XW, Chen J, Song JH. Anatomic versus non-anatomic resection of hepatocellular carcinoma with microvascular invasion: A systematic review and meta-analysis. Asian J Surg. 2021 Sep;44(9):1143-1150. doi: 10.1016/j.asjsur.2021.02.023. Epub 2021 Mar 23.

    PMID: 33766529BACKGROUND

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PMID: 19638912BACKGROUND

  • Mohkam K, Farges O, Vibert E, Soubrane O, Adam R, Pruvot FR, Regimbeau JM, Adham M, Boleslawski E, Mabrut JY; Association de Chirurgie Hepato-Biliaire et de Transplantation (ACHBT) French Hepatectomy Study Group. Risk score to predict biliary leakage after elective liver resection. Br J Surg. 2018 Jan;105(1):128-139. doi: 10.1002/bjs.10647. Epub 2017 Nov 13.

    PMID: 29131313BACKGROUND

  • Maulat C, Regimbeau JM, Buc E, Boleslawski E, Belghiti J, Hardwigsen J, Vibert E, Delpero JR, Tournay E, Arnaud C, Suc B, Pessaux P, Muscari F. Prevention of biliary fistula after partial hepatectomy by transcystic biliary drainage: randomized clinical trial. Br J Surg. 2020 Jun;107(7):824-831. doi: 10.1002/bjs.11405. Epub 2020 Jan 9.

    PMID: 31916605BACKGROUND

  • Vigano L, Torzilli G, Troisi R, Aldrighetti L, Ferrero A, Majno P, Toso C, Figueras J, Cherqui D, Adam R, Kokudo N, Hasegawa K, Guglielmi A, Krawczyk M, Giuliante F, Hilal MA, Costa-Maia J, Pinna AD, Cescon M, De Santibanes E, Urbani L, Pawlik T, Costa G, Zugna D; CLISCO group. Minor Hepatectomies: Focusing a Blurred Picture: Analysis of the Outcome of 4471 Open Resections in Patients Without Cirrhosis. Ann Surg. 2019 Nov;270(5):842-851. doi: 10.1097/SLA.0000000000003493.

    PMID: 31569127BACKGROUND

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PMID: 18929686BACKGROUND

  • Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

    PMID: 31078660BACKGROUND

Study Officials

  • Felice Giulante, MD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felice Giuliante, MD

CONTACT

+39 0630156857felice.giuliante@policlinicogemelli.it

Agostino Maria De Rose, MD, PhD

CONTACT

+39 0630155855agostinomaria.derose@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

January 30, 2023

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

August 14, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)