Validation of Esophageal Variceal Grading: A Comparative Study of Upper Gastrointestinal (GI) Endoscopy and Capsule Endoscopy

NCT00475592 | Withdrawn DMC

• 1 other identifier: VaricealGrading_EsoCapsule
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop a grading system for esophageal varices using capsule endoscopy in patients with portal hypertension and cirrhosis.

Conditions

Esophageal and Gastric Varices

Keywords

Esophageal Varices; Gastric Varices; Capsule Endoscopy; Portal Hypertension; Cirrhosis; Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study will be to develop a grading system for esophageal varices using capsule endoscopy.

  Two years

Secondary Outcomes (1)

• Secondary endpoints include sensitivity, specificity, inter- and intraobserver variation of variceal grading using capsule endoscopy; patient acceptance; and a cost comparison (facility + professional fees) of the two screening methods.

  Two years

Study Arms (2)

Capsule Endoscopy

EXPERIMENTAL

Device: Esophageal Capsule Endoscopy

Upper Gastrointestinal Endoscopy

ACTIVE COMPARATOR

Device: Upper Gastrointestinal Endoscopy

Interventions

Esophageal Capsule Endoscopy DEVICE

Capsule Endoscopy

Upper Gastrointestinal Endoscopy DEVICE

Upper Gastrointestinal Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced cirrhosis with portal hypertension based on imaging, clinical suspicion, or liver biopsy
• Age greater than or equal to 18 years old
• Able to give consent

You may not qualify if:

• Current implantable cardioverter-defibrillators or pacemaker in place
• Suspected intestinal obstruction
• Esophageal swallowing disorder
• Esophageal stenosis
• Age less than 18 years old
• Pregnancy
• Known Zenker's diverticulum
• Patients with previous endoscopic or surgical esophageal treatment

Sponsors & Collaborators

• Johns Hopkins University: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal; Fibrosis; Gastrointestinal Hemorrhage

Interventions

Endoscopy; Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures

Study Officials

• Paul J Thuluvath, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

US (1)