Effect of Meal on Portal and Esophagus Variceal Pressure | NCT00485290

Studies
Effect of Meal on Portal and Esophagus Variceal Pressure

NCT00485290

Sponsor

Hvidovre University Hospital

Status

Terminated

Last Update Posted

Aug 7, 2008Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cirrhosis
Esophageal Varices

Interventions

meal (food intake)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No eligible patients were found, the study stopped without including any patients

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jun 11, 2007

First Submission Date that Met QC Criteria

Jun 11, 2007

First Posted Date

Jun 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2008

Last Update Posted Date

Aug 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
meal (food intake)	Behavioral	600 kcal. (16% protein, 49%carbohydrate, 35% fatt)

Measure	Description	Time Frame
effect of meal on variceal pressure		30 minutes after the meal

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Large Esophageal varices

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Flemming Bendtsen, MD, DMsc.	Hvidovre University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital		Hvidovre		2650	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D004932	Esophageal and Gastric Varices
D006975	Hypertension, Portal

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D062407	Meals
D004435	Eating

Ancestor Terms

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided