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Enhancing Detection of Small Esophageal Varices by PillCam ESO

Primary Purpose

Esophageal Varices

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Capsule endoscopy (PillCam ESO)

EGD

Capsule endoscopy (PillCam ESO) with abdominal binder

About this trial

This is an interventional diagnostic trial for Esophageal Varices focused on measuring Small grade esophageal varices, capsule endoscopy, PillCam ESO, abdominal binder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Screening esophagoduodenoscopy (EGD)

Capsule Endoscopy

Capsule Endoscopy with abdominal binder

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

Detection rate of esophageal varices using different screening modalities.

Secondary Outcome Measures

Patient tolerability of each screening modality.

Full Information

NCT ID

NCT00911131

First Posted

May 29, 2009

Last Updated

June 18, 2015

Sponsor

Medical College of Wisconsin

Collaborators

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT00911131

Brief Title

Enhancing Detection of Small Esophageal Varices by PillCam ESO

Official Title

A New Technique to Enhance Detection of Small Esophageal Varices by PillCam ESO Capsule Endoscopy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Loss of funding

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medical College of Wisconsin

Collaborators

Medtronic - MITG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Varices

Keywords

Small grade esophageal varices, capsule endoscopy, PillCam ESO, abdominal binder

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Investigator

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Screening esophagoduodenoscopy (EGD)

Arm Type

Active Comparator

Arm Description

Arm Title

Capsule Endoscopy

Arm Type

Active Comparator

Arm Description

Arm Title

Capsule Endoscopy with abdominal binder

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Capsule endoscopy (PillCam ESO)

Other Intervention Name(s)

PillCam ESO

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

EGD

Other Intervention Name(s)

Esophagoduodenoscopy

Intervention Description

Patients will undergo conventional EGD under conscious sedation for routine screening of esophageal varices.

Intervention Type

Device

Intervention Name(s)

Capsule endoscopy (PillCam ESO) with abdominal binder

Other Intervention Name(s)

PillCam ESO

Intervention Description

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.

Primary Outcome Measure Information:

Title

Detection rate of esophageal varices using different screening modalities.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Patient tolerability of each screening modality.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kia Saeian, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mukund Venu, MD

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

10643630

Citation

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Results Reference

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PubMed Identifier

7026343

Citation

Christensen E, Fauerholdt L, Schlichting P, Juhl E, Poulsen H, Tygstrup N. Aspects of the natural history of gastrointestinal bleeding in cirrhosis and the effect of prednisone. Gastroenterology. 1981 Nov;81(5):944-52.

Results Reference

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PubMed Identifier

9731585

Citation

Grace ND, Groszmann RJ, Garcia-Tsao G, Burroughs AK, Pagliaro L, Makuch RW, Bosch J, Stiegmann GV, Henderson JM, de Franchis R, Wagner JL, Conn HO, Rodes J. Portal hypertension and variceal bleeding: an AASLD single topic symposium. Hepatology. 1998 Sep;28(3):868-80. doi: 10.1002/hep.510280339. No abstract available.

Results Reference

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PubMed Identifier

11097497

Citation

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Results Reference

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PubMed Identifier

10343210

Citation

Assy N, Rosser BG, Grahame GR, Minuk GY. Risk of sedation for upper GI endoscopy exacerbating subclinical hepatic encephalopathy in patients with cirrhosis. Gastrointest Endosc. 1999 Jun;49(6):690-4. doi: 10.1016/s0016-5107(99)70283-x.

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PubMed Identifier

12358240

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Enhancing Detection of Small Esophageal Varices by PillCam ESO

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