Liver CancerIBERLIVERNCT03166683
Standard of Care Versus Hemopatch® During Liver Resection
A study testing Hemopatch in people with Liver Cancer and Hemorrhage Liver, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Trial summary
This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hemorrhage Liver, Bile Leak
- What is being tested?
- Hemopatch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age: ≥18 years.
- Patients with an indication for open liver resection (segmental or non-segmental).
- Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
- Willing and able to complete the clinical trial procedures, as described in the protocol.
- Signed written informed consent to participate in this clinical trial.
Who cannot join
- Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
- Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
- Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
- Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
- Pregnancy or breast-feeding.
- Inability to understand the nature and the extent of the trial and the procedures required.
Show all 9Show fewer
- Criteria to be checked during surgery (intraoperative exclusion criteria):
- Infected wound area.
- Persistent major bleeding after primary hemostasis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)
This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.
Read the detailed description
Liver resection is the only potentially curative treatment in malignant or benign hepatobiliary lesions. Biliary leakage is a postoperative complication (5-10%) which may have considerable consequences. Surgical techniques and devices to facilitate the control of bile leakage have been developed in the last decades and have minimized operative risks of liver resection. Nevertheless, hepatic parenchymal transection can be associated with bile leakage due to the division of small ducts. In order to achieve control over parenchyma from the section surface and to prevent intraperitoneal complications attributed to bile leakage/bleeding various locally applicable agents are in use. This control of bile leakage include fibrin sealant and synthetic glues. Evidence from randomized controlled trials regarding the use of fibrin sealants on their own or combined with a collagenfleece has shown Little efficacy.
A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) [Baxter, Vienna, Austria] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.
The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.
- Conditions
- Liver Cancer, Hemorrhage Liver, Bile Leak, Surgery, Tumor Liver
- Being tested
- Hemopatch, Standard of care
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchOther
Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement
Standard of careOther
Standard of care include other sealant / hemostatic devices as patches or liquid/gels
| Study group | Role | What they receive |
|---|---|---|
| Hemopatch | Experimental | Use of hemopatch like a control of bile leakage/sealant during liver resection surgery. Receives: Other: Hemopatch |
| Standard of care | Active comparator | Application of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of bile leakage
analysis of bilirubin (mg/dL),in the drain fluid
Measured: From day 1 to day 4
Secondary outcomes (4)
Bleeding
Total volume of blood, quantified though aspiration and drainage (Quantification of total number of deciliters (dL) of blood gathered)
Measured: From the surgery day until day 30
Analysis of hemoglobin
Quantification of hemoglobin (mg/dL), in the drain fluid
Measured: From the surgery day until day 30
Bleeding complications
Presence (YES or NO compatible imagen of hemorrhage )of post-hepatectomy hemorrhage or Hematoma formation (Valid imaging tests of presence or absence can be checked by : abdomen ecography, TAC or RNM)
Measured: From the surgery day until day 30
Transfusion requirements
Quantification of number of packed red blood cells
Measured: From the surgery day until day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startDec 2017 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study
- Masking
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel Angel Gómez Bravo, PhD, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166683
- Sponsor's protocol ID
- IBERLIVER
- Acronym
- IBERLIVER
- Status last verified
- Nov 2017
- First submitted
- 4 Apr 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data for IPD is planned to be shared with all participants within 6 months of data completion
Publications
Baumgartner B, Draxler W, Lewis KM. Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy. J Invest Surg. 2016 Dec;29(6):343-351. doi: 10.3109/08941939.2016.1154627. Epub 2016 Mar 22.
PubMed 27002742Erdogan D, Busch OR, van Delden OM, Rauws EA, Gouma DJ, van Gulik TM. Incidence and management of bile leakage after partial liver resection. Dig Surg. 2008;25(1):60-6. doi: 10.1159/000118024. Epub 2008 Feb 22.
PubMed 18292662Figueras J, Llado L, Miro M, Ramos E, Torras J, Fabregat J, Serrano T. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Ann Surg. 2007 Apr;245(4):536-42. doi: 10.1097/01.sla.0000245846.37046.57.
PubMed 17414601Guillaud A, Pery C, Campillo B, Lourdais A, Sulpice L, Boudjema K. Incidence and predictive factors of clinically relevant bile leakage in the modern era of liver resections. HPB (Oxford). 2013 Mar;15(3):224-9. doi: 10.1111/j.1477-2574.2012.00580.x. Epub 2012 Oct 4.
PubMed 23374363Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014.
PubMed 24729905Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6.
PubMed 25106082Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.
PubMed 25085811Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, Buchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7.
PubMed 21762295Nagano Y, Togo S, Tanaka K, Masui H, Endo I, Sekido H, Nagahori K, Shimada H. Risk factors and management of bile leakage after hepatic resection. World J Surg. 2003 Jun;27(6):695-8. doi: 10.1007/s00268-003-6907-x. Epub 2003 May 13.
PubMed 12732991Ruggiero R, Docimo L, Tolone S, De Palma M, Musella M, Pezzolla A, Gubitosi A, Parmeggiani D, Pirozzi R, Gili S, Parisi S, D'Alessandro A, Docimo G. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery. A prospective study. Int J Surg. 2016 Apr;28 Suppl 1:S17-21. doi: 10.1016/j.ijsu.2015.12.044. Epub 2015 Dec 17.
PubMed 26708861Sadamori H, Yagi T, Matsuda H, Shinoura S, Umeda Y, Fujiwara T. Intractable bile leakage after hepatectomy for hepatocellular carcinoma in 359 recent cases. Dig Surg. 2012;29(2):149-56. doi: 10.1159/000337313. Epub 2012 May 3.
PubMed 22555445Sakamoto K, Tamesa T, Yukio T, Tokuhisa Y, Maeda Y, Oka M. Risk Factors and Managements of Bile Leakage After Hepatectomy. World J Surg. 2016 Jan;40(1):182-9. doi: 10.1007/s00268-015-3156-8.
PubMed 26159119Tanaka S, Hirohashi K, Tanaka H, Shuto T, Lee SH, Kubo S, Takemura S, Yamamoto T, Uenishi T, Kinoshita H. Incidence and management of bile leakage after hepatic resection for malignant hepatic tumors. J Am Coll Surg. 2002 Oct;195(4):484-9. doi: 10.1016/s1072-7515(02)01288-7.
PubMed 12375753Weltert L, D'Aleo S, Chirichilli I, Falco M, Turani F, Bellisario A, De Paulis R. Prospective Randomized Clinical Trial of HEMOPATCH Topical Sealant in Cardiac Surgery. Surg Technol Int. 2016 Oct;XXIX:sti29/756. Epub 2016 Jul 29.
PubMed 27466878Yamashita Y, Hamatsu T, Rikimaru T, Tanaka S, Shirabe K, Shimada M, Sugimachi K. Bile leakage after hepatic resection. Ann Surg. 2001 Jan;233(1):45-50. doi: 10.1097/00000658-200101000-00008.
PubMed 11141224
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard of Care Versus a New Collagen and Polyethylene Glycol Haemostatic/Sealant Patch (Hemopatch) During Liver Resection. A Multicentre, Non-inferiority Prospective Randomized Study (IBERLIVER-study)
- ClinicalTrials.gov ID
- NCT03166683
- Acronym / sponsor ID
- IBERLIVER / IBERLIVER
- Conditions
- Liver Cancer, Hemorrhage Liver, Bile Leak, Surgery, Tumor Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 25 May 2017 (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.
This multicentre prospective and randomized study aims to compare the sealant effect after surgical liver resection of a new collagen - polyethylene glycol hemostatic / sealant patch (Hemopatch) vs standard of care.
Detailed description
Liver resection is the only potentially curative treatment in malignant or benign hepatobiliary lesions. Biliary leakage is a postoperative complication (5-10%) which may have considerable consequences. Surgical techniques and devices to facilitate the control of bile leakage have been developed in the last decades and have minimized operative risks of liver resection. Nevertheless, hepatic parenchymal transection can be associated with bile leakage due to the division of small ducts. In order to achieve control over parenchyma from the section surface and to prevent intraperitoneal complications attributed to bile leakage/bleeding various locally applicable agents are in use. This control of bile leakage include fibrin sealant and synthetic glues. Evidence from randomized controlled trials regarding the use of fibrin sealants on their own or combined with a collagenfleece has shown Little efficacy.
A new collagen and polyethylene glycol hemostatic/sealant patch (Hemopatch) [Baxter, Vienna, Austria] is indicated for local hemostasis of capillary bleeding and bleeding of parenchymal organs. The felt structure being rich in surface gives a framework for the adhesion of blood platelets, thus providing an additional impetus as a sealant agent.
The investigators aim to demonstrate the sealing capability of hemopatch and to prove its non-inferiority to the standard of care (may include other sealant / hemostatic devices as patches or liquid/gels). There will be 2 groups to compare. The study group where Hemopatch is applied at the end of surgery. And the control group, where standard of care measures will be applied at the end of surgery. The end-point is the assessment of control of bile leakage at 1, 2, 3, and 4 day, during the hospital stay and or at 30 days for both treatment group. The secondary end-points are bleeding complications (re-bleeding, hematoma formation), volume of fluid drained on day 1 to day 4 after surgery, hemoglobin variation from pre-operative until discharge and post-operatory complications until 30th day pos-op.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized (1:1) study of 2 treatment groups (hemopatch versus standard of care) in liver resection surgery. Non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Hemopatch | Experimental | Other: HemopatchUse of hemopatch like a control of bile leakage/sealant during liver resection surgery. |
| Standard of care | Active comparator | Other: Standard of careApplication of standards of care, may include other sealant / hemostatic devices as patches or liquid/gels, during liver resection surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥18 years.
- Patients with an indication for open liver resection (segmental or non-segmental).
- Target bleeding site of generalized bleeding that persists on the cut surface of the liver in which hemostasis cannot be achieved by conventional methods.
- Willing and able to complete the clinical trial procedures, as described in the protocol.
- Signed written informed consent to participate in this clinical trial.
Key exclusion criteria (9 listed)
- Presence of coagulation disorder, Klatskin tumour. Cirrhosis, re-hepatectomies and biliary resections
- Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints.
- Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamic acid, activated factor VII, fibrinogen and aprotinin.
- Known allergy or hypersensitivity to a component of the investigational treatments Hemopatch® ,to riboflavin or to proteins of bovine origin.
- Pregnancy or breast-feeding.
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 |
|---|---|---|
| HemopatchLiver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement | Other | Hemopatch |
| Standard of careStandard of care include other sealant / hemostatic devices as patches or liquid/gels | Other | Standard of care |
Primary outcome
Control of bile leakage
Time frame: From day 1 to day 4
analysis of bilirubin (mg/dL),in the drain fluid
4 secondary outcomes
Bleeding
Time frame: From the surgery day until day 30
Analysis of hemoglobin
Time frame: From the surgery day until day 30
Bleeding complications
Time frame: From the surgery day until day 30
Transfusion requirements
Time frame: From the surgery day until day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Background: PubMed 27002742Baumgartner B, Draxler W, Lewis KM. Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy. J Invest Surg. 2016 Dec;29(6):343-351. doi: 10.3109/08941939.2016.1154627. Epub 2016 Mar 22.
- Background: PubMed 18292662Erdogan D, Busch OR, van Delden OM, Rauws EA, Gouma DJ, van Gulik TM. Incidence and management of bile leakage after partial liver resection. Dig Surg. 2008;25(1):60-6. doi: 10.1159/000118024. Epub 2008 Feb 22.
- Background: PubMed 17414601Figueras J, Llado L, Miro M, Ramos E, Torras J, Fabregat J, Serrano T. Application of fibrin glue sealant after hepatectomy does not seem justified: results of a randomized study in 300 patients. Ann Surg. 2007 Apr;245(4):536-42. doi: 10.1097/01.sla.0000245846.37046.57.
- Background: PubMed 23374363Guillaud A, Pery C, Campillo B, Lourdais A, Sulpice L, Boudjema K. Incidence and predictive factors of clinically relevant bile leakage in the modern era of liver resections. HPB (Oxford). 2013 Mar;15(3):224-9. doi: 10.1111/j.1477-2574.2012.00580.x. Epub 2012 Oct 4.
- Background: PubMed 24729905Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014.
- Background: PubMed 25106082Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6.
- Background: PubMed 25085811Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1.
- Background: PubMed 21762295Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, Buchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7.
- Background: PubMed 12732991Nagano Y, Togo S, Tanaka K, Masui H, Endo I, Sekido H, Nagahori K, Shimada H. Risk factors and management of bile leakage after hepatic resection. World J Surg. 2003 Jun;27(6):695-8. doi: 10.1007/s00268-003-6907-x. Epub 2003 May 13.
- Background: PubMed 26708861Ruggiero R, Docimo L, Tolone S, De Palma M, Musella M, Pezzolla A, Gubitosi A, Parmeggiani D, Pirozzi R, Gili S, Parisi S, D'Alessandro A, Docimo G. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery. A prospective study. Int J Surg. 2016 Apr;28 Suppl 1:S17-21. doi: 10.1016/j.ijsu.2015.12.044. Epub 2015 Dec 17.
- Background: PubMed 22555445Sadamori H, Yagi T, Matsuda H, Shinoura S, Umeda Y, Fujiwara T. Intractable bile leakage after hepatectomy for hepatocellular carcinoma in 359 recent cases. Dig Surg. 2012;29(2):149-56. doi: 10.1159/000337313. Epub 2012 May 3.
- Background: PubMed 26159119Sakamoto K, Tamesa T, Yukio T, Tokuhisa Y, Maeda Y, Oka M. Risk Factors and Managements of Bile Leakage After Hepatectomy. World J Surg. 2016 Jan;40(1):182-9. doi: 10.1007/s00268-015-3156-8.
- Individual participant dataSharing planned: Yes. Anonymized data for IPD is planned to be shared with all participants within 6 months of data completion
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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. This study is not recruiting at the moment.
Miguel Angel Gómez Bravo, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
Questions about this trial
What is this clinical trial studying?
A study testing Hemopatch in people with Liver Cancer and Hemorrhage Liver, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Rosso Fernández, PhD (0034955013414, claram.rosso.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of bile leakage (time frame: From day 1 to day 4). 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 NCT03166683, which also lists 15 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 9 Nov 2017.