Enhancing Detection of Small Esophageal Varices by PillCam ESO
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|ClinicalTrials.gov Identifier: NCT00911131|
Recruitment Status : Withdrawn (Loss of funding)
First Posted : June 1, 2009
Last Update Posted : June 19, 2015
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:
- To determine if using an abdominal binder to increase IAP can increase the detection rate of small esophageal varices when using capsule endoscopy.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Varices||Device: Capsule endoscopy (PillCam ESO) Procedure: EGD Device: Capsule endoscopy (PillCam ESO) with abdominal binder||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A New Technique to Enhance Detection of Small Esophageal Varices by PillCam ESO Capsule Endoscopy|
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.
Patients will undergo conventional EGD under conscious sedation for routine screening of esophageal varices.
Other Name: Esophagoduodenoscopy
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).
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
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.
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
- Detection rate of esophageal varices using different screening modalities. [ Time Frame: 30 days ]
- Patient tolerability of each screening modality. [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911131
|Study Director:||Kia Saeian, MD||Medical College of Wisconsin|
|Principal Investigator:||Mukund Venu, MD||Medical College of Wisconsin|