Gastrointestinal ischemia in patients with portal vein thrombosis

ISRCTN ISRCTN14235960
DOI https://doi.org/10.1186/ISRCTN14235960
Secondary identifying numbers NL24909.078.08
Submission date
16/02/2015
Registration date
19/02/2015
Last edited
23/04/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Jihan Harki
Scientific

's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

ORCiD logoORCID ID 0000-0001-6762-6874

Study information

Study designPatients with non-cirrhotic, non-malignant PVT were studied in this single-center prospective cohort study in a tertiary care center.
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleGastrointestinal ischemia in patients with portal vein thrombosis: a prospective study
Study acronymGASTROINTESTINAL ISCHEMIA IN PVT
Study objectivesThe objective of this study is to assess the presence, clinical presentation and characteristics of gastrointestinal ischemia in patients with PVT.
Ethics approval(s)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.
Health condition(s) or problem(s) studiedPortal vein thrombosis (PVT)
InterventionClinical symptoms of gastrointestinal ischemia were assessed by a structured questionnaire, VLS measurements and radiological evaluation of the mesenteric arteries
Intervention typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. Symptoms of gastrointestinal ischemia in patients with PVT
2. Mucosal saturation measurements in the gastrointestinal tract in patients with PVT
Secondary outcome measuresFactors related to gastrointestinal ischemia in patients with PVT
Overall study start date08/12/2008
Completion date01/01/2015

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. 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
Key exclusion criteria1. Patients < 18years
2. No informed consent
3. Patients with liver cirrhosis
4. Patients with malignancy
5. Pregnant or lactating women
Date of first enrolment18/01/2009
Date of final enrolment01/01/2015

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus MC University Medical Center
's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor information

Erasmus MC University Medical Center
Hospital/treatment centre

's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Charity

The Foundation for Liver and Gastrointestinal Research (SLO) (Netherlands)

No information available

Results and Publications

Intention to publish date01/03/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan
IPD sharing plan