CompletedNCT04180735PerfogreffeUpdated Nov 29, 2019

Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital

An observational study in Liver Transplantation, Intestinal Perforation and Digestive System Fistula, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-11-29.

Sponsored by University Hospital, Montpellier · Observational

Study type: Observational
Model: Case-control
Time perspective: Retrospective
Enrollment: 60
Ages: 18 Years to 65 Years
Sex: All

Study 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 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 studied

Liver Transplantation
Intestinal Perforation
Digestive System Fistula
Intestinal Fistula

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Keywords

Risk Factors
Survival

In context

Intestinal Perforation

36 studies on the registry are indexed under Intestinal Perforation; 5 are open to participants now.

This study's enrollment of 60 is below the median of 203 across 20 observational studies indexed under Intestinal Perforation.

Browse Intestinal Perforation studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Browse University Hospital, Montpellier studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

No exclusion criteria

Study design

Observational model: Case-control
Time perspective: Retrospective
Enrollment: 60 participants (actual)
Patient registry: No

Groups and cohorts

Perforation
Perforation
Procedure: Liver transplantation
No perforation
No perforation
Procedure: Liver transplantation

Interventions

ProcedureLiver transplantation
Liver transplantation

What researchers measure

Primary outcomes

Evaluate the total length of stay
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.

Secondary outcomes

Evaluate the occurrence of death
Evaluate the occurrence of death
Time frame: 1 month, 3 months, 6 months.
Evaluate the total number of complications
Evaluate the total number of complications
Time frame: 1 month, 3 months, 6 months.
Evaluate the number of perforations
Evaluate the number of perforations
Time frame: 1 month, 3 months, 6 months.
Evaluate the quality of life
Evaluate the quality of life
Time frame: 1 month, 3 months, 6 months.
Evaluate the occurrence of an acute or chronic rejection
Evaluate the occurrence of an acute or chronic rejection
Time frame: 1 month, 3 months, 6 months.

Study locations

1 site

Uh Montpellier
Montpellier, 34295, France

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Oct 2019, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered: Aug 6, 2019
First posted: Nov 29, 2019
StartActual: Sep 30, 2019
Primary completionActual: Oct 1, 2019
CompletionActual: Oct 30, 2019
Last update: Nov 29, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04180735
Lead sponsor: University Hospital, Montpellier
Collaborators: Université Montpellier
Responsible party: Sponsor
First posted: Nov 29, 2019
Start date: Sep 30, 2019
Primary completion: Oct 1, 2019
Completion: Oct 30, 2019
Last update: Nov 29, 2019

Study contacts

Fabrizio PANARO, PhD

study director · UH MONTPELLIER

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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