NCT00485290

Brief Summary

The reason why esophagus varices suddenly rupture and start to bleed is unclear. Food intake increase the hepatic blood flow and the portal pressure, but it is yet unknown if there is also an increase in variceal pressure. The aim of this study is to evaluate the efficacy of a meal on variceal pressure with a non invasive endoscopic measurement device, and compare it with portal pressure.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

August 7, 2008

Status Verified

November 1, 2007

Enrollment Period

10 months

First QC Date

June 11, 2007

Last Update Submit

August 6, 2008

Conditions

CirrhosisEsophageal Varices

Keywords

cirrhosis, Portal Hypertension, Esophageal Varices, Meal

Outcome Measures

Primary Outcomes (1)

  • effect of meal on variceal pressure

    30 minutes after the meal

Interventions

meal (food intake)BEHAVIORAL

600 kcal. (16% protein, 49%carbohydrate, 35% fatt)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Large Esophageal varices

You may not qualify if:

  • Treatment with beta-blocking agents
  • Respiratory diseases that contradict endoscopy
  • Gastric-retention
  • Former gastric resection
  • Resent sclerotherapy or former banding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

FibrosisEsophageal and Gastric VaricesHypertension, Portal

Interventions

MealsEating

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesNutritional Physiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Flemming Bendtsen, MD, DMsc.

    Hvidovre University Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 11, 2007

First Posted

June 12, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

August 7, 2008

Record last verified: 2007-11

Locations

DK(1)