Liver ResectionPhase 2NCT01921985
Terlipressin Administration in Patients Undergoing Major Liver Resection
A Phase 2 study testing Terlipressin in people with Liver Resection and Liver Failure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study investigates if the administration of terlipressin reduces complications after major liver surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Resection, Liver Failure
- What is being tested?
- Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Mar 2018
- Phase
- Phase 2
- 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
- Patients undergoing resection of 3 or more liver segments
- Minimum age of 18
- Any gender
- Written informed consent
Who cannot join
- Preoperative renal failure (GFR < 50ml/min)
- Severe liver dysfunction (Child-Turcotte-Pugh grade C)
- Hyponatremia (<132mmol/l)
- Severe aortic regurgitation, severe mitral regurgitation, heart failure
- Symptomatic coronary heart disease
- Bradycardic arrhythmia (heart rate < 60/min)
Show all 12Show fewer
- Peripheral artery occlusive disease (clinical stadium II-IV)
- Dilatative arteriopathy, history of subarachnoidal bleeding
- Decompensated arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment)
- Present or suspected acute mesenteric ischemia
- Septic shock
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Visceral Surgery, University Hospital Berne
Bern, 3010
About this study
Official title: Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial
This study investigates if the administration of terlipressin reduces complications after major liver surgery.
Read the detailed description
Background
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration.
Objective
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.
Methods
- Conditions
- Liver Resection, Liver Failure
- Being tested
- Terlipressin, Placebo
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg).
PlaceboDrug
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Active comparator | Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg). Receives: Drug: Terlipressin |
| NaCl | Placebo comparator | Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incident of a composite end point
Measured: one month
Secondary outcomes (7)
Number of patients with pleural effusion
Measured: one month
Number of patients with surgical site infection
Measured: one month
Number of patients with sepsis
Measured: one month
Number of patients with pneumonia
Measured: one month
Number of patients with intraabdominal hematoma
Measured: one month
Number of patients with acute renal failure
Measured: one month
Number of patients with blood transfusion
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver ResectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, Professor Dr. med., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921985
- Sponsor's protocol ID
- 190/11
- Status last verified
- Mar 2018
- First submitted
- 9 Aug 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kohler A, Perrodin S, De Gottardi A, Candinas D, Beldi G. Effectiveness of terlipressin for prevention of complications after major liver resection - A randomized placebo-controlled trial. HPB (Oxford). 2020 Jun;22(6):884-891. doi: 10.1016/j.hpb.2019.10.011. Epub 2019 Oct 31.
PubMed 31680011
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin Administration in Patients Undergoing Major Liver Resection: a Prospective Randomized Blinded Trial
- ClinicalTrials.gov ID
- NCT01921985
- Acronym / sponsor ID
- 190/11
- Conditions
- Liver Resection, Liver Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Aug 2013 (estimated)
- 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 study investigates if the administration of terlipressin reduces complications after major liver surgery.
Detailed description
Background
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration.
Objective
Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection.
Methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Active comparator | Drug: TerlipressinTerlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg). |
| NaCl | Placebo comparator | Drug: PlaceboPlacebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing resection of 3 or more liver segments
- Minimum age of 18
- Any gender
- Written informed consent
Key exclusion criteria (12 listed)
- Preoperative renal failure (GFR < 50ml/min)
- Severe liver dysfunction (Child-Turcotte-Pugh grade C)
- Hyponatremia (<132mmol/l)
- Severe aortic regurgitation, severe mitral regurgitation, heart failure
- Symptomatic coronary heart disease
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 |
|---|---|---|
| TerlipressinTerlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg). | Drug | Terlipressin |
| PlaceboPlacebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours). | Drug | NaCl |
Primary outcome
Number of patients with incident of a composite end point
Time frame: one month
7 secondary outcomes
Number of patients with pleural effusion
Time frame: one month
Number of patients with surgical site infection
Time frame: one month
Number of patients with sepsis
Time frame: one month
Number of patients with pneumonia
Time frame: one month
Number of patients with intraabdominal hematoma
Time frame: one month
Number of patients with acute renal failure
Time frame: one month
Number of patients with blood transfusion
Time frame: one month
Results and safety
The study was stopped early (reason given: Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 31680011Kohler A, Perrodin S, De Gottardi A, Candinas D, Beldi G. Effectiveness of terlipressin for prevention of complications after major liver resection - A randomized placebo-controlled trial. HPB (Oxford). 2020 Jun;22(6):884-891. doi: 10.1016/j.hpb.2019.10.011. Epub 2019 Oct 31.
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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.
Guido Beldi, Professor Dr. med. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terlipressin in people with Liver Resection and Liver Failure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 29 Mar 2018. 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 Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study was stopped early (reason given: Interim analysis revealed that no statistical difference will be identified after inclusion of the patient cohort as foreseen in the sample size calculation). Results are not available in the source record.
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?
Number of patients with incident of a composite end point (time frame: one month). 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 NCT01921985, which also lists 1 linked publication.
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 29 Mar 2018.