Liver TransplantationPerfogreffeNCT04180735
Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
An observational study of Liver Transplantation and Intestinal Perforation, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor. The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Intestinal Perforation, Digestive System Fistula
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2019to 30 Oct 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
Who may be able to join
- Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
- for the group Perforation: patients having during the follow-up a complication such as intestinal perforation. The complete list uses the ICD-10 codes for intestinal perforation, esophageal perforation, duodenal perforation etc.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.
The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.
Read the detailed description
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.
The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme. Previous studies have shown a possible implication of drugs or medical history or intraoperative complications. The investigators aim to describe the other possible risk factors (such as portal vein clampage) and the type of surgery done after the diagnosis and its impact on survival as well.
- Conditions
- Liver Transplantation, Intestinal Perforation, Digestive System Fistula, Intestinal Fistula
- Being tested
- Liver transplantation
- Keywords
- Risk Factors, Survival
- Medical subject headings
- Intestinal Perforation, Digestive System Fistula, Intestinal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
Liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Perforation | Perforation Receives: Procedure: Liver transplantation | |
| No perforation | No perforation Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the total length of stay
Evaluate the total length of stay
Measured: 1 month
Evaluate the total length of stay
Evaluate the total length of stay
Measured: 3 months
Evaluate the total length of stay
Evaluate the total length of stay
Measured: 6 months.
Secondary outcomes (5)
Evaluate the occurrence of death
Evaluate the occurrence of death
Measured: 1 month, 3 months, 6 months.
Evaluate the total number of complications
Evaluate the total number of complications
Measured: 1 month, 3 months, 6 months.
Evaluate the number of perforations
Evaluate the number of perforations
Measured: 1 month, 3 months, 6 months.
Evaluate the quality of life
Evaluate the quality of life
Measured: 1 month, 3 months, 6 months.
Evaluate the occurrence of an acute or chronic rejection
Evaluate the occurrence of an acute or chronic rejection
Measured: 1 month, 3 months, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start30 Sep 2019
- Primary completion1 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Fabrizio PANARO, PhD, Study director, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180735
- Sponsor's protocol ID
- RECHMPL19_0362
- Acronym
- Perfogreffe
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.
- ClinicalTrials.gov ID
- NCT04180735
- Acronym / sponsor ID
- Perfogreffe / RECHMPL19_0362
- Conditions
- Liver Transplantation, Intestinal Perforation, Digestive System Fistula, Intestinal Fistula
- Keywords
- Risk Factors, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 29 Nov 2019 (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.
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.
The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.
Detailed description
Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor.
The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme. Previous studies have shown a possible implication of drugs or medical history or intraoperative complications. The investigators aim to describe the other possible risk factors (such as portal vein clampage) and the type of surgery done after the diagnosis and its impact on survival as well.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perforation | – | Procedure: Liver transplantationPerforation |
| No perforation | – | Procedure: Liver transplantationNo perforation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
Key inclusion criteria (2 listed)
- Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
- for the group Perforation: patients having during the follow-up a complication such as intestinal perforation. The complete list uses the ICD-10 codes for intestinal perforation, esophageal perforation, duodenal perforation etc.
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Liver transplantationLiver transplantation | Procedure or surgery | No perforation, Perforation |
Primary outcome
Evaluate the total length of stay
Time frame: 1 month
Evaluate the total length of stay
Evaluate the total length of stay
Time frame: 3 months
Evaluate the total length of stay
Evaluate the total length of stay
Time frame: 6 months.
Evaluate the total length of stay
5 secondary outcomes
Evaluate the occurrence of death
Time frame: 1 month, 3 months, 6 months.
Evaluate the total number of complications
Time frame: 1 month, 3 months, 6 months.
Evaluate the number of perforations
Time frame: 1 month, 3 months, 6 months.
Evaluate the quality of life
Time frame: 1 month, 3 months, 6 months.
Evaluate the occurrence of an acute or chronic rejection
Time frame: 1 month, 3 months, 6 months.
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 29 Nov 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Fabrizio PANARO, PhD study director
UH MONTPELLIER
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 Liver Transplantation and Intestinal Perforation, run by University Hospital, Montpellier 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 2 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 29 Nov 2019. 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?
Evaluate the total length of stay (time frame: 1 month). The study lists 3 primary outcomes in all. 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 29 Nov 2019.