Plain English Summary
Background and study aims
Portal vein thrombosis (PVT) refers to a blockage of the portal vein (the blood vessel supplying blood to the liver from the intestines) by a blood clot. It often leads to portal hypertension, where the blood pressure in the portal vein is higher than it should be. PVT can occur suddenly (acute) or chronic (which results from acute PVT that does not respond to treatment). Gastrointestinal ischemia, caused by a fall in the blood flow to the intestines, is a feared complication of PVT. It can result in intestinal infarction, a life-threatening complication where parts of the bowel start to die due to lack of a blood supply (and therefore oxygen) that often requires immediate surgery. Treatment of acute PVT therefore aims at vascular recanalization (reopening blocked blood vessels), to prevent portal hypertension and gastrointestinal ischemia. Due to the rarity of the disease and lack of adequate diagnostic tools in the past, most data on gastrointestinal ischemia in patients with PVT stem from studies using past clinical records from selected patient populations. With the development of minimally invasive techniques, such as visible light spectroscopy (VLS), the ability to diagnose gastrointestinal ischemia has greatly improved. Therefore, we studied patients with PVT using VLS, radiological examination, and questionnaires. The aim of this study is to test for the presence, clinical presentation and characteristics of gastrointestinal ischemia in patients with PVT.
Who can participate?
Patients over 18 with PVT not caused by cirrhosis of the liver or cancer
What does the study involve?
For each participant in the study, clinical symptoms of gastrointestinal ischemia are assessed by a structured questionnaire, VLS measurements and radiological evaluation of the mesenteric arteries (arteries supplying blood to the intestines)
What are the possible benefits and risks of participating?
Patients who are willing to participate in the study will be fully informed of the reason of the study, the extent and duration of their co-operation, the voluntary nature of their involvement and their freedom to drop out at any time without reason. They will be told that they will not get any personal medical benefits from participating. There are no risks involved in participating this study. Patients with PVT have endoscopy on regular basis and VLS is a painless method to measure the oxygen saturation.
Where is the study run from?
Erasmus MC University Medical Center (Netherlands)
When is the study starting and how long is it expected to run for?
December 2008 to January 2015
Who is funding the study?
The Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands)
Who is the main contact?
Dr Jihan Harki
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jihan Harki
ORCID ID
http://orcid.org/0000-0001-6762-6874
Contact details
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL24909.078.08
Study information
Scientific title
Gastrointestinal ischemia in patients with portal vein thrombosis: a prospective study
Acronym
GASTROINTESTINAL ISCHEMIA IN PVT
Study hypothesis
The objective of this study is to assess the presence, clinical presentation and characteristics of gastrointestinal ischemia in patients with PVT.
Ethics approval
1. Institutional Review Board of the Erasmus MC University Medical Center Rotterdam (Netherlands), ref: MEC 2008-375.
2. Central Committee on Research Involving Human Subjects (CCMO) (Netherlands), ref: NL24909.078.08.
Study design
Patients with non-cirrhotic, non-malignant PVT were studied in this single-center prospective cohort study in a tertiary care center.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Portal vein thrombosis (PVT)
Intervention
Clinical symptoms of gastrointestinal ischemia were assessed by a structured questionnaire, VLS measurements and radiological evaluation of the mesenteric arteries
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Symptoms of gastrointestinal ischemia in patients with PVT
2. Mucosal saturation measurements in the gastrointestinal tract in patients with PVT
Secondary outcome measures
Factors related to gastrointestinal ischemia in patients with PVT
Overall trial start date
08/12/2008
Overall trial end date
01/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with non-cirrhotic, non-malignant PVT. Acute and chronic PVT were defined according to Baveno V criteria as presence of PVT with or without portal cavernoma and portal hypertension.
2. Aged 18 years and over
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Patients < 18years
2. No informed consent
3. Patients with liver cirrhosis
4. Patients with malignancy
5. Pregnant or lactating women
Recruitment start date
18/01/2009
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus MC University Medical Center
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
Funders
Funder type
Charity
Funder name
The Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
01/03/2015
Participant level data
Available on request
Basic results (scientific)
Publication list