End Stage Liver DiseaseNCT03609411
Splenectomy During Whole Liver Transplantation
An observational study of End Stage Liver Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- End Stage Liver Disease
- What is being tested?
- Splenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2017
- Phase
- Observational
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Among the 906 liver transplantations performed between 1994 and 2013 at the Liver Transplant Department of the Croix-Rousse University Hospital, Lyon-France, all 47 liver transplantations with simultaneous splenectomy were included and compared to 94 transplant recipients without splenectomy after a 1:2 matching for gender, age at transplantation, year of liver transplantation, MELD score, platelet level and presence of hepatocellular carcinoma.
Who may be able to join
- Patients undergoing liver transplantation between 1994 and 2013
Who cannot join
- Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis
Trial locations and contacts
1 site in 1 country.
About this study
Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.
Read the detailed description
Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.
- Conditions
- End Stage Liver Disease
- Being tested
- Splenectomy
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplenectomyProcedure or surgery
Also called Liver transplantation
Splenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels.
| Study group | Role | What they receive |
|---|---|---|
| Splenectomy | Patients undergoing liver transplantation with simultaneous splenectomy Receives: Procedure: Splenectomy | |
| Liver transplantation | Patients undergoing liver transplantation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month post-operative mortality
Measured: At 3 months post surgery
Secondary outcomes (3)
Post-operative morbidity
Incidence of portal-vein thrombosis within 3 months post liver transplantation
Measured: 3 months post surgery
One-year mortality
Measured: One year after surgery
Mortality at 5 years
Measured: Five years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609411
- Sponsor's protocol ID
- CRC_GHN_2018_002
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splenectomy During Whole Liver Transplantation
- ClinicalTrials.gov ID
- NCT03609411
- Acronym / sponsor ID
- CRC_GHN_2018_002
- Conditions
- End Stage Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Aug 2018 (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.
Indications for splenectomy during whole liver transplantation remain controversial and splenectomy is often avoided because of common complications. The objective is to evaluate specific complications of these combined procedures.
Detailed description
Data on patients who underwent splenectomy during liver transplantation were retrospectively analyzed . Participants underwent splenectomy as part of routine medical care. Patients undergoing simultaneous liver transplantation and splenectomy were matched to a non-splenectomy group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Splenectomy | – | Procedure: SplenectomyPatients undergoing liver transplantation with simultaneous splenectomy |
| Liver transplantation | – | –Patients undergoing liver transplantation only |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Among the 906 liver transplantations performed between 1994 and 2013 at the Liver Transplant Department of the Croix-Rousse University Hospital, Lyon-France, all 47 liver transplantations with simultaneous splenectomy were included and compared to 94 transplant recipients without splenectomy after a 1:2 matching for gender, age at transplantation, year of liver transplantation, MELD score, platelet level and presence of hepatocellular carcinoma.
Key inclusion criteria (1 listed)
- Patients undergoing liver transplantation between 1994 and 2013
Key exclusion criteria (1 listed)
- Data from living donor patients, split liver transplantation, patients with pre- or post-operative splenectomy in medical history, and patients under 16 years were excluded from analysis
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 |
|---|---|---|
| SplenectomyAlso: Liver transplantationSplenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels. | Procedure or surgery | Splenectomy |
Primary outcome
3-month post-operative mortality
Time frame: At 3 months post surgery
3 secondary outcomes
Post-operative morbidity
Time frame: 3 months post surgery
One-year mortality
Time frame: One year after surgery
Mortality at 5 years
Time frame: Five years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 End Stage Liver Disease, run by Hospices Civils de Lyon at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
3-month post-operative mortality (time frame: At 3 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2018.