Condition category
Circulatory System
Date applied
16/02/2015
Date assigned
19/02/2015
Last edited
23/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Erasmus MC University Medical Center

Sponsor details

's Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes