Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Enhancing Detection of Small Esophageal Varices by PillCam ESO

This study has been withdrawn prior to enrollment.
(Loss of funding)
Sponsor:
Collaborator:
Given Imaging Ltd.
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00911131
First received: May 29, 2009
Last updated: April 18, 2011
Last verified: April 2011

May 29, 2009
April 18, 2011
Not Provided
Not Provided
Detection rate of esophageal varices using different screening modalities. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00911131 on ClinicalTrials.gov Archive Site
Patient tolerability of each screening modality. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Enhancing Detection of Small Esophageal Varices by PillCam ESO
A New Technique to Enhance Detection of Small Esophageal Varices by PillCam ESO Capsule Endoscopy

Increasing intra-abdominal pressure (IAP) with an abdominal binder will increase pressure within smaller esophageal varices which will therefore enhance the ability of capsule endoscopy to detect these varices better.

Therefore, the aims of the investigators' study are as follows:

  1. To determine if using an abdominal binder to increase IAP can increase the detection rate of small esophageal varices when using capsule endoscopy.
  2. To determine if using an abdominal binder to increase IAP during capsule endoscopy has a comparable detection rate of small esophageal varices to conventional endoscopy.

Esophageal variceal bleeding is a common and life-threatening complication of portal hypertension in patients with cirrhosis of liver. It is associated with a mortality rate of up to 50% in these patients. Prophylactic treatments to prevent variceal bleeding, therefore, assume paramount clinical significance. Currently, primary prophylactic treatments using pharmacologic agents with non-selective beta blockers as well as endoscopic variceal ligation (EVL) are effectively employed in preventing variceal bleeding. The American Association for the Study of Liver Disease (AASLD) guidelines recommend that patients with Child's stage A cirrhosis and portal hypertension with platelet count less than 140,000/mmq or portal vein diameter > 13mm and those patients classified as Child's B and C cirrhosis should undergo screening endoscopy for esophageal varices. Patients with cirrhosis and no esophageal varices detected during screening should undergo endoscopy ever three years. Patients with small esophageal varices are recommended to be screened endoscopically every 1 to 2 years.

Currently, esophagogastroduodenoscopy (EGD) under conscious sedation is the gold standard for variceal screening. However, EGD has certain limitations especially when used in patients with cirrhosis of the liver. Prolonged conscious sedation may have an adverse effect on encephalopathy. EGD also may not be cost effective for screening esophageal varices.

The use of PillCam ESO capsule endoscopy to detect esophageal varices has become an attractive alternative to conventional endoscopy especially in patients unwilling to undergo EGD. Identifying patients with small varices, which have the potential for progression to large varices and bleeding, is an important clinical issue to address.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Esophageal Varices
  • Device: Capsule endoscopy (PillCam ESO)
    The capsule endoscope is placed in the mouth and the patient is asked to swallow it with 100cc of water with simethicone in the supine position. Recording is done for 2 minute in this position and then the head is elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient sips 10cc of water and after 15 seconds, they sit upright and sip water again. They can then walk and resume normal activity for 15 minutes.
    Other Name: PillCam ESO
  • Procedure: EGD
    Patients will undergo conventional EGD under conscious sedation for routine screening of esophageal varices.
    Other Name: Esophagoduodenoscopy
  • Device: Capsule endoscopy (PillCam ESO) with abdominal binder
    An abdominal binder with and inflatable girdle is wrapped around the stomach prior to swallowing the capsule endoscope. The girdle is inflated to 10mmHg for 10 minutes. The capsule is swallowed by the patient and the routine method for the procedure is performed.
    Other Name: PillCam ESO
  • Active Comparator: Screening esophagoduodenoscopy (EGD)

    EGD will be performed utilizing conscious sedation. During EGD, the endoscopist will capture pictures of the esophageal body, Z-line, lower esophagus and proximal gastric folds. Grading of esophageal varices will be performed by all investigators using the Italian Liver cirrhosis project.

    Patients who are found to have small grade varices and meet the inclusion and exclusion criteria will be enrolled in the study.

    Intervention: Procedure: EGD
  • Active Comparator: Capsule Endoscopy
    The capsule endoscope will be swallowed by the participant with 100cc of water and simethicone in the supine position. Recording is done for 2 minute in this position and then the head will be elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient will sip10cc of water and after 15 seconds, they will sit upright and sip water again. They can then walk and resume normal activity for 15 minutes. The videos will be reviewed and graded by a gastroenterologist experienced with capsule endoscopy and will be blinded to the patient's clinical and procedural history as well as the most recent EGD. The varices will be graded using the Given Imaging software that grades varices as no varices (C0), small varices or < 25% of esophageal circumference (C1), and large varices or > 25% of esophageal circumference (C2).
    Intervention: Device: Capsule endoscopy (PillCam ESO)
  • Active Comparator: Capsule Endoscopy with abdominal binder
    Before swallowing the capsule endoscope, an inflatable girdle is wrapped around the waist above the umbilicus and held in place by a an abdominal binder. The pressure is increased by 10mmHg for 10 minutes. The PillCam ESO is placed in the mouth and the patient is asked to swallow it with 100cc of water with simethicone in the supine position. Recording is done for 2 minute in this position and then the head is elevated to 30 degrees for 2 minutes and then 60 degrees for 1 minute. After 1 minute, the patient sips 10cc of water and after 15 seconds, they sit upright and sip water again. They can then walk and resume normal activity for 15 minutes.
    Intervention: Device: Capsule endoscopy (PillCam ESO) with abdominal binder

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
Not Provided
Not Provided

Inclusion Criteria:

  • patients identified with grade I and grade II esophageal varices by conventional endoscopy who are returning for screening or surveillance
  • patients who have had endoscopic banding of varices in the past
  • patients aged 18 years or older
  • patients able to give consent
  • patients eligible and willing to undergo upper endoscopy and PillCam ESO capsule endoscopy

Exclusion Criteria:

  • dysphagia
  • Zenker's diverticulum
  • pregnancy
  • esophageal stricture
  • gastric or intestinal obstruction
  • multiple abdominal surgeries
  • cardiac pacemakers
  • implanted electronic medical devices
  • cognitive impairment
  • also, patients found to have bleeding, requiring banding, or other complications on screening EGD the day of the trial will not proceed to capsule endoscopy
  • urine pregnancy test will be conducted prior to participation; this is part of the standard procedure for women of child-bearing age undergoing upper endoscopy in the GI lab
  • all patients being evaluated for the current study will be evaluated for the presence or absence of overt portosystemic encephalopathy:

    • Those found to have overt portosystemic encephalopathy will then be graded based on the standard scale of grade 1 through 4 portosystemic encephalopathy. Assessment of whether patients with liver disease and hepatocellular carcinoma possess decisional capacity is essentially the same as for other subjects with the exception that due diligence must be used to address whether there is any evidence of active ongoing overt portosystemic encephalopathy. From the available data and current standards of care, patients with stage 1 overt hepatic encephalopathy are decisional but may have minimal impairment in their cognitive skills particularly in the domains of attention and sleep. Decisional capacity in patients with grades 2-4 overt portosystemic encephalopathy is impaired and will lead to them bring excluded from the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00911131
PRO 8503
Yes
Kia Saeian, Medical College of Wisconsin
Medical College of Wisconsin
Given Imaging Ltd.
Study Director: Kia Saeian, MD Medical College of Wisconsin
Principal Investigator: Mukund Venu, MD Medical College of Wisconsin
Medical College of Wisconsin
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP