Liver TransplantationPhase 1/2NCT07651748
Secretin in Ex-situ Liver Perfusion
A Phase 1/2 study testing Secretin administration during ex-situ liver machine perfusion in people with Liver Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The main objective is to assess whether the use of human synthetic secretin in a clinical (COR-)NMP procedure can restore physiological HCO3- content of the bile during ex-situ NMP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Secretin administration during ex-situ liver machine perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Apr 2025to Oct 2026
- Phase
- Phase 1/2
- 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
Who may be able to join
- Adult patients (>18 years old)
- Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.
Who cannot join
- Multiorgan transplantation
- Split liver transplant
- Living donor liver transplantation
- Organ donation after Euthanasia
- Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
About this study
Official title: Secretin Therapy During Ex-Situ Normothermic Liver Machine Perfusion: A Critical Factor for Restoration of Bile Duct Physiology and the Protective "Bicarbonate Umbrella"
The main objective is to assess whether the use of human synthetic secretin in a clinical (COR-)NMP procedure can restore physiological HCO3- content of the bile during ex-situ NMP.
Read the detailed description
Liver transplantation is the only curative treatment option for patients with end-stage liver disease, but it is limited by a large gap between the number of patients in need and donor organs available. Strikingly, in 2021, 38% of available donor livers were disposed being assessed as non-transplantable in The Netherlands, while approximately 20% of patients on the liver transplant waitlist died or became too sick to be transplanted. Similar or even higher discard rates are observed in other countries, such as the US. Acceptance of extended criteria donor (ECD) livers, referring to suboptimal grafts from older, obese, or otherwise comorbid donors and organs from donation after circulatory death (DCD), is proposed to meet this growing demand. However, transplantation of these livers is associated with a higher rate of post-operative complications, increased hospital costs and reduced graft survival, compared to standard grafts.
Machine perfusion (MP) is a dynamic, isolated platform to preserve liver grafts out-of-the-body by circulation of an oxygenated perfusate. While dual hypothermic oxygenated perfusion (DHOPE) reconditions the graft in a hypometabolic state, normothermic MP (NMP) allows full assessment of metabolic function at physiological temperatures. The sequential protocol of both perfusion techniques, with controlled oxygenated rewarming for 60 minutes (COR), named DHOPE-COR-NMP is currently used in clinical practice for viability assessment of high-risk ECD-livers prior to transplantation. The decision moment whether a liver is suitable for transplantation is after 150 minutes of NMP. Unfortunately, one third of these tested livers are currently discarded, mainly because of not meeting the predefined criteria for cholangiocyte viability (own, unpublished data). The platform of MP allows graft reconditioning in an isolated circuit, with no systemic effects of administered therapeutics in the recipient as the liver is thoroughly flushed out before implantation in the recipient, thereby limiting side-effects.
Secretin is a hormone with a short half-life that is produced in the duodenum, with systemic effects. In the liver, secretin stimulates cholangiocytes through the secretin receptor. This leads to an increase in intracellular cyclic AMP (cAMP), subsequently activating Protein kinase A (PKA), eventually leading to a downstream excretion of chloride through the CFTR channels. Chloride is a leading force in bicarbonate excretion, as this excreted chloride is resorbed through Anion-Exchanger-2 (AE2) and exchanged for bicarbonate. In a physiological setting, cholangiocytes are protected from bile-acid injury by this "bicarbonate umbrella". With the excretion of bicarbonate, water is also excreted through Aquaporin-1 (AQP-1), and thus increasing total bile production. The increase in bile production is one of the main reasons for secretin to be administered during Magnetic Resonance Cholangio-Pancreatography (MRCP) imaging of the biliary tree in its current application as diagnostic tool.
The perfusate that is used for NMP, is based on an oxygen carrier (currently red blood cells), colloids and certain supplements to reach a near-physiological environment in oncotic pressure and nutrients. In physiological conditions, bile contains high amounts of bicarbonate, resulting in an alkalotic fluid. This earlier mentioned "bicarbonate umbrella" protects the cholangiocytes from bile acid-induced injury. During NMP, bile pH and bile bicarbonate levels are lower compared to a physiological setting (own, unpublished data). The investigators hypothesize that cholangiocytes during NMP are not able to demonstrate their full potential, as they are not stimulated by secretin like in-vivo physiology. As explained earlier, the increase in bile production is a result of increasing bicarbonate excretion, and thereby biliary pH, creating a more physiological environment for the liver and bile ducts. Possible further injury of the bile duct from bile acid toxicity could be prevented by adding secretin to the perfusate during COR-NMP. This however, can only be researched after this initial validation of the safety and efficacy of secretin as a missing component to reach physiological conditions during ex-situ liver NMP.
- Conditions
- Liver Transplantation
- Being tested
- Secretin administration during ex-situ liver machine perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secretin administration during ex-situ liver machine perfusionDrug
In at least 20 cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming (COR) for 60 minutes (DHOPE-COR-NMP) livers, the investigators will add 16mcg of synthetic human secretin to the perfusate at the start of COR phase of the protocol and a second dose of 16mcg during the NMP phase after the decision moment whether to transplant or not. This number was chosen based on an average acceptance rate of 70%, and therefore would generate 14 transplanted livers while 6 livers are expected not to be transplanted (not passing the standard viability criteria).
As the acceptance rate is subject to fluctuations over time (due to variations in the quality of donor offers), the investigators want to include at least 14 transplanted livers and 6 livers that are not transplanted (not passing the standard viability criteria), in order to have the best representative situation. When both numbers are reached, inclusions will stop.
| Study group | Role | What they receive |
|---|---|---|
| Historical control group | No intervention | Historical cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming for 60 minutes (DHOPE-COR-NMP) livers that did not receive synthetic human secretin during the perfusion. |
| Secretin administration during liver machine perfusion (COR-NMP) | Experimental | These livers will be treated during ex-situ machine perfusion with a blood-based perfusate with doses of human synthetic secretin. Receives: Drug: Secretin administration during ex-situ liver machine perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholangiocellular viability assessment - Biliary Bicarbonate
A comparison will be made between livers that pass cholangiocyte viability assessment and livers that do not pass cholangiocyte viability assessment in the secretin cohort of this study. Analysis will be performed on bile composition, with the main outcome being the response in biliary bicarbonate increase 30 minutes after the second dose of administration (directly after viability assessment with the go-no go for transplantation).
Measured: Periprocedural
Secondary outcomes (1)
Cholangiocellular viability assessment - Bile production
A comparison will be made between livers that pass cholangiocyte viability assessment and livers that do not pass cholangiocyte viability assessment in the secretin cohort of this study. Analysis will be performed on bile production with the volume (mL) increase 30 minutes after the second dose of administration (directly after viability assessment with the go-no go for transplantation).
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start26 Apr 2025
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- One study group receives secretin therapy, whilst the other group consists of historical controls without secretin therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Robert J. Porte, Erasmus Medical Center
- Investigators
- Robert J Porte, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651748
- Sponsor's protocol ID
- MEC-2024-0678
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jong IEM, Bodewes SB, van Leeuwen OB, Oosterhuis D, Lantinga VA, Thorne AM, Lascaris B, van den Heuvel MC, Wells RG, Olinga P, de Meijer VE, Porte RJ. Restoration of Bile Duct Injury of Donor Livers During Ex Situ Normothermic Machine Perfusion. Transplantation. 2023 Jun 1;107(6):e161-e172. doi: 10.1097/TP.0000000000004531. Epub 2023 May 23.
PubMed 36721302Dutch Transplant Registry, Numbers about organ transplantation 2021-2022
Eden J, Sousa Da Silva R, Cortes-Cerisuelo M, Croome K, De Carlis R, Hessheimer AJ, Muller X, de Goeij F, Banz V, Magini G, Compagnon P, Elmer A, Lauterio A, Panconesi R, Widmer J, Dondossola D, Muiesan P, Monbaliu D, de Rosner van Rosmalen M, Detry O, Fondevila C, Jochmans I, Pirenne J, Immer F, Oniscu GC, de Jonge J, Lesurtel M, De Carlis LG, Taner CB, Heaton N, Schlegel A, Dutkowski P. Utilization of livers donated after circulatory death for transplantation - An international comparison. J Hepatol. 2023 May;78(5):1007-1016. doi: 10.1016/j.jhep.2023.01.025. Epub 2023 Feb 4.
PubMed 36740047Orman ES, Mayorga ME, Wheeler SB, Townsley RM, Toro-Diaz HH, Hayashi PH, Barritt AS 4th. Declining liver graft quality threatens the future of liver transplantation in the United States. Liver Transpl. 2015 Aug;21(8):1040-50. doi: 10.1002/lt.24160.
PubMed 25939487Nemes B, Gaman G, Polak WG, Gelley F, Hara T, Ono S, Baimakhanov Z, Piros L, Eguchi S. Extended-criteria donors in liver transplantation Part II: reviewing the impact of extended-criteria donors on the complications and outcomes of liver transplantation. Expert Rev Gastroenterol Hepatol. 2016 Jul;10(7):841-59. doi: 10.1586/17474124.2016.1149062. Epub 2016 Mar 2.
PubMed 26831547van Leeuwen OB, Bodewes SB, Lantinga VA, Haring MPD, Thorne AM, Bruggenwirth IMA, van den Berg AP, de Boer MT, de Jong IEM, de Kleine RHJ, Lascaris B, Nijsten MWN, Reyntjens KMEM, de Meijer VE, Porte RJ. Sequential hypothermic and normothermic machine perfusion enables safe transplantation of high-risk donor livers. Am J Transplant. 2022 Jun;22(6):1658-1670. doi: 10.1111/ajt.17022. Epub 2022 Apr 18.
PubMed 35286759Tabibian JH, Masyuk AI, Masyuk TV, O'Hara SP, LaRusso NF. Physiology of cholangiocytes. Compr Physiol. 2013 Jan;3(1):541-65. doi: 10.1002/cphy.c120019.
PubMed 23720296Hohenester S, Wenniger LM, Paulusma CC, van Vliet SJ, Jefferson DM, Elferink RP, Beuers U. A biliary HCO3- umbrella constitutes a protective mechanism against bile acid-induced injury in human cholangiocytes. Hepatology. 2012 Jan;55(1):173-83. doi: 10.1002/hep.24691.
PubMed 21932391
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretin Therapy During Ex-Situ Normothermic Liver Machine Perfusion: A Critical Factor for Restoration of Bile Duct Physiology and the Protective "Bicarbonate Umbrella"
- ClinicalTrials.gov ID
- NCT07651748
- Acronym / sponsor ID
- MEC-2024-0678
- Conditions
- Liver Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Jun 2026 (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 main objective is to assess whether the use of human synthetic secretin in a clinical (COR-)NMP procedure can restore physiological HCO3- content of the bile during ex-situ NMP.
Detailed description
Liver transplantation is the only curative treatment option for patients with end-stage liver disease, but it is limited by a large gap between the number of patients in need and donor organs available. Strikingly, in 2021, 38% of available donor livers were disposed being assessed as non-transplantable in The Netherlands, while approximately 20% of patients on the liver transplant waitlist died or became too sick to be transplanted. Similar or even higher discard rates are observed in other countries, such as the US. Acceptance of extended criteria donor (ECD) livers, referring to suboptimal grafts from older, obese, or otherwise comorbid donors and organs from donation after circulatory death (DCD), is proposed to meet this growing demand. However, transplantation of these livers is associated with a higher rate of post-operative complications, increased hospital costs and reduced graft survival, compared to standard grafts.
Machine perfusion (MP) is a dynamic, isolated platform to preserve liver grafts out-of-the-body by circulation of an oxygenated perfusate. While dual hypothermic oxygenated perfusion (DHOPE) reconditions the graft in a hypometabolic state, normothermic MP (NMP) allows full assessment of metabolic function at physiological temperatures. The sequential protocol of both perfusion techniques, with controlled oxygenated rewarming for 60 minutes (COR), named DHOPE-COR-NMP is currently used in clinical practice for viability assessment of high-risk ECD-livers prior to transplantation. The decision moment whether a liver is suitable for transplantation is after 150 minutes of NMP. Unfortunately, one third of these tested livers are currently discarded, mainly because of not meeting the predefined criteria for cholangiocyte viability (own, unpublished data). The platform of MP allows graft reconditioning in an isolated circuit, with no systemic effects of administered therapeutics in the recipient as the liver is thoroughly flushed out before implantation in the recipient, thereby limiting side-effects.
Secretin is a hormone with a short half-life that is produced in the duodenum, with systemic effects. In the liver, secretin stimulates cholangiocytes through the secretin receptor. This leads to an increase in intracellular cyclic AMP (cAMP), subsequently activating Protein kinase A (PKA), eventually leading to a downstream excretion of chloride through the CFTR channels. Chloride is a leading force in bicarbonate excretion, as this excreted chloride is resorbed through Anion-Exchanger-2 (AE2) and exchanged for bicarbonate. In a physiological setting, cholangiocytes are protected from bile-acid injury by this "bicarbonate umbrella". With the excretion of bicarbonate, water is also excreted through Aquaporin-1 (AQP-1), and thus increasing total bile production. The increase in bile production is one of the main reasons for secretin to be administered during Magnetic Resonance Cholangio-Pancreatography (MRCP) imaging of the biliary tree in its current application as diagnostic tool.
The perfusate that is used for NMP, is based on an oxygen carrier (currently red blood cells), colloids and certain supplements to reach a near-physiological environment in oncotic pressure and nutrients. In physiological conditions, bile contains high amounts of bicarbonate, resulting in an alkalotic fluid. This earlier mentioned "bicarbonate umbrella" protects the cholangiocytes from bile acid-induced injury. During NMP, bile pH and bile bicarbonate levels are lower compared to a physiological setting (own, unpublished data). The investigators hypothesize that cholangiocytes during NMP are not able to demonstrate their full potential, as they are not stimulated by secretin like in-vivo physiology. As explained earlier, the increase in bile production is a result of increasing bicarbonate excretion, and thereby biliary pH, creating a more physiological environment for the liver and bile ducts. Possible further injury of the bile duct from bile acid toxicity could be prevented by adding secretin to the perfusate during COR-NMP. This however, can only be researched after this initial validation of the safety and efficacy of secretin as a missing component to reach physiological conditions during ex-situ liver NMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One study group receives secretin therapy, whilst the other group consists of historical controls without secretin therapy
| Arm | Type | Receives |
|---|---|---|
| Historical control group | No intervention | –Historical cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming for 60 minutes (DHOPE-COR-NMP) livers that did not receive synthetic human secretin during the perfusion. |
| Secretin administration during liver machine perfusion (COR-NMP) | Experimental | Drug: Secretin administration during ex-situ liver machine perfusionThese livers will be treated during ex-situ machine perfusion with a blood-based perfusate with doses of human synthetic secretin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years old)
- Donor livers that required resuscitation and viability assessment through the previously published sequential hypo- and normothermic liver machine perfusion (DHOPE-COR-NMP) protocol based on a blood-based perfusate.
Key exclusion criteria (5 listed)
- Multiorgan transplantation
- Split liver transplant
- Living donor liver transplantation
- Organ donation after Euthanasia
- Previous donor organ perfusion (e.g. Normothermic Regional Perfusion)
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 |
|---|---|---|
| Secretin administration during ex-situ liver machine perfusionIn at least 20 cases of sequential hypo- to normothermic machine perfusion, linked with controlled oxygenated rewarming (COR) for 60 minutes (DHOPE-COR-NMP) livers, the investigators will add 16mcg of synthetic human secretin to the perfusate at the start of COR phase of the protocol and a second dose of 16mcg during the NMP phase after the decision moment whether to transplant or not. This number was chosen based on an average acceptance rate of 70%, and therefore would generate 14 transplanted livers while 6 livers are expected not to be transplanted (not passing the standard viability criteria). As the acceptance rate is subject to fluctuations over time (due to variations in the quality of donor offers), the investigators want to include at least 14 transplanted livers and 6 livers that are not transplanted (not passing the standard viability criteria), in order to have the best representative situation. When both numbers are reached, inclusions will stop. | Drug | Secretin administration during liver machine perfusion (COR-NMP) |
Primary outcome
Cholangiocellular viability assessment - Biliary Bicarbonate
Time frame: Periprocedural
A comparison will be made between livers that pass cholangiocyte viability assessment and livers that do not pass cholangiocyte viability assessment in the secretin cohort of this study. Analysis will be performed on bile composition, with the main outcome being the response in biliary bicarbonate increase 30 minutes after the second dose of administration (directly after viability assessment with the go-no go for transplantation).
1 secondary outcome
Cholangiocellular viability assessment - Bile production
Time frame: Periprocedural
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 16 Jun 2026.
- Background: PubMed 36721302de Jong IEM, Bodewes SB, van Leeuwen OB, Oosterhuis D, Lantinga VA, Thorne AM, Lascaris B, van den Heuvel MC, Wells RG, Olinga P, de Meijer VE, Porte RJ. Restoration of Bile Duct Injury of Donor Livers During Ex Situ Normothermic Machine Perfusion. Transplantation. 2023 Jun 1;107(6):e161-e172. doi: 10.1097/TP.0000000000004531. Epub 2023 May 23.
- BackgroundDutch Transplant Registry, Numbers about organ transplantation 2021-2022
- Background: PubMed 36740047Eden J, Sousa Da Silva R, Cortes-Cerisuelo M, Croome K, De Carlis R, Hessheimer AJ, Muller X, de Goeij F, Banz V, Magini G, Compagnon P, Elmer A, Lauterio A, Panconesi R, Widmer J, Dondossola D, Muiesan P, Monbaliu D, de Rosner van Rosmalen M, Detry O, Fondevila C, Jochmans I, Pirenne J, Immer F, Oniscu GC, de Jonge J, Lesurtel M, De Carlis LG, Taner CB, Heaton N, Schlegel A, Dutkowski P. Utilization of livers donated after circulatory death for transplantation - An international comparison. J Hepatol. 2023 May;78(5):1007-1016. doi: 10.1016/j.jhep.2023.01.025. Epub 2023 Feb 4.
- Background: PubMed 25939487Orman ES, Mayorga ME, Wheeler SB, Townsley RM, Toro-Diaz HH, Hayashi PH, Barritt AS 4th. Declining liver graft quality threatens the future of liver transplantation in the United States. Liver Transpl. 2015 Aug;21(8):1040-50. doi: 10.1002/lt.24160.
- Background: PubMed 26831547Nemes B, Gaman G, Polak WG, Gelley F, Hara T, Ono S, Baimakhanov Z, Piros L, Eguchi S. Extended-criteria donors in liver transplantation Part II: reviewing the impact of extended-criteria donors on the complications and outcomes of liver transplantation. Expert Rev Gastroenterol Hepatol. 2016 Jul;10(7):841-59. doi: 10.1586/17474124.2016.1149062. Epub 2016 Mar 2.
- Background: PubMed 35286759van Leeuwen OB, Bodewes SB, Lantinga VA, Haring MPD, Thorne AM, Bruggenwirth IMA, van den Berg AP, de Boer MT, de Jong IEM, de Kleine RHJ, Lascaris B, Nijsten MWN, Reyntjens KMEM, de Meijer VE, Porte RJ. Sequential hypothermic and normothermic machine perfusion enables safe transplantation of high-risk donor livers. Am J Transplant. 2022 Jun;22(6):1658-1670. doi: 10.1111/ajt.17022. Epub 2022 Apr 18.
- Background: PubMed 23720296Tabibian JH, Masyuk AI, Masyuk TV, O'Hara SP, LaRusso NF. Physiology of cholangiocytes. Compr Physiol. 2013 Jan;3(1):541-65. doi: 10.1002/cphy.c120019.
- Background: PubMed 21932391Hohenester S, Wenniger LM, Paulusma CC, van Vliet SJ, Jefferson DM, Elferink RP, Beuers U. A biliary HCO3- umbrella constitutes a protective mechanism against bile acid-induced injury in human cholangiocytes. Hepatology. 2012 Jan;55(1):173-83. doi: 10.1002/hep.24691.
- 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.
Robert J Porte, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Secretin administration during ex-situ liver machine perfusion in people with Liver Transplantation, run by Erasmus Medical Center at 1 site in Netherlands.
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 2 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. 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 Netherlands. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholangiocellular viability assessment - Biliary Bicarbonate (time frame: Periprocedural). 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 NCT07651748, which also lists 8 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 16 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.