Bile LeakEBILROKNCT05705557
Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Open Liver Resection
An observational study of Bile Leak, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Leak
- What is being tested?
- ABSOLOK™ Clip System
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jan 2023to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 years;
- Subject has given his informed consent and signed consent;
- Patients undergoing open liver resection.
Who cannot join
- Surgery made in emergency;
- Surgery by laparoscopy;
- Need to perform a bilio-digestive anastomosis;
- Preoperative jaundice (total bilirubin > 3 mg/mL).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
Agostino Maria De Rose, MD, PhD, +39 0630155855, agostinomaria.derose@policlinicogemelli.it
Simone Vani, BSc, +39 0630155642, simone.vani@policlinicogemelli.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Bile Leak
- Being tested
- ABSOLOK™ Clip System
- Keywords
- Liver resection, Hepatectomy, Absolok, Bile Leak, Laparotomy, Open Liver resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSOLOK™ Clip SystemDevice
Use of ABSOLOK™ Clip System during parenchymal transection for open liver resection
| Study group | Role | What they receive |
|---|---|---|
| OPEN Liver Resection | Patients undergoing laparotomic (OPEN) Liver Resection Receives: Device: ABSOLOK™ Clip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (5)
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
Measured: 90 days
Additional maneuvers for treat biliary fistula
Participants will be followed for the duration of hospital stay and Follow Up
Measured: 90 days
Lenght of post-operative stay
Participants will be followed for the duration of hospital stay
Measured: 90 days
Rate of post-operative Morbidity
Participants will be followed for the duration of hospital stay and Follow Up
Measured: 90 days
Rate of post-operative Mortality
Assessment of mortality during the hospitalization or Follow Up
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start30 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bile LeakStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Felice Giulante, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705557
- Sponsor's protocol ID
- 5139
- Acronym
- EBILROK
- Status last verified
- Aug 2025
- First submitted
- 20 Jan 2023
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32335245Martin 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.
PubMed 29247421Brooke-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.
PubMed 25059275Gorgec 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.
PubMed 35213428Koch 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.
PubMed 21316725Deng 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.
PubMed 31464101Sun 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.
PubMed 33766529Clavien 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.
PubMed 19638912Mohkam 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.
PubMed 29131313Maulat 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.
PubMed 31916605Vigano 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.
PubMed 31569127Harris 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.
PubMed 18929686Harris 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.
PubMed 31078660
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of ABSOLOK™ Clip System-RFP-2021-01 in Achieving BIliostasis During Parenchymal Transection for Open Liver Resection
- ClinicalTrials.gov ID
- NCT05705557
- Acronym / sponsor ID
- EBILROK / 5139
- Conditions
- Bile Leak
- Keywords
- Liver resection, Hepatectomy, Absolok, Bile Leak, Laparotomy, Open Liver resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPEN Liver Resection | – | Device: ABSOLOK™ Clip SystemPatients undergoing laparotomic (OPEN) Liver Resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Subject has given his informed consent and signed consent;
- Patients undergoing open liver resection.
Key exclusion criteria (4 listed)
- Surgery made in emergency;
- Surgery by laparoscopy;
- Need to perform a bilio-digestive anastomosis;
- Preoperative jaundice (total bilirubin > 3 mg/mL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSOLOK™ Clip SystemUse of ABSOLOK™ Clip System during parenchymal transection for open liver resection | Device | OPEN Liver Resection |
Primary outcome
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
5 secondary outcomes
Duration of POBL (Post-operative bile leakage) and the timing of drainage removal
Time frame: 90 days
Additional maneuvers for treat biliary fistula
Time frame: 90 days
Lenght of post-operative stay
Time frame: 90 days
Rate of post-operative Morbidity
Time frame: 90 days
Rate of post-operative Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 32335245Torzilli 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.
- Background: PubMed 29247421Martin 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.
- Background: PubMed 25059275Brooke-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.
- Background: PubMed 35213428Gorgec 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.
- Background: PubMed 21316725Koch 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.
- Background: PubMed 31464101Deng 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.
- Background: PubMed 33766529Sun 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.
- Background: PubMed 19638912Clavien 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.
- Background: PubMed 29131313Mohkam 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.
- Background: PubMed 31916605Maulat 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.
- Background: PubMed 31569127Vigano 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.
- Background: PubMed 18929686Harris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felice Giulante, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Leak, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felice Giuliante, MD (+39 0630156857, felice.giuliante@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Overall Post-Operative Bile Leakage (POBL) using ABSOLOK™ Clips during liver resection (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05705557, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.