Enhancing Detection of Small Esophageal Varices by PillCam ESO

Esophageal Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00911131
• Other study ID #: PRO 8503
• Status: Withdrawn
• Phase: Phase 3
• First received: May 29, 2009
• Last updated: June 18, 2015

Study information

• Verified date: June 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Varicose Veins

Intervention

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.

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Given Imaging Ltd.

References & Publications (13)

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. — View 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. — View Citation

D'Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis. 1999;19(4):475-505. Review. Erratum in: Semin Liver Dis 2000;20(3):399. — View Citation

de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227. — View Citation

de Franchis R. Updating consensus in portal hypertension: report of the Baveno III Consensus Workshop on definitions, methodology and therapeutic strategies in portal hypertension. J Hepatol. 2000 Nov;33(5):846-52. — View Citation

Eisen GM, Eliakim R, Zaman A, Schwartz J, Faigel D, Rondonotti E, Villa F, Weizman E, Yassin K, deFranchis R. The accuracy of PillCam ESO capsule endoscopy versus conventional upper endoscopy for the diagnosis of esophageal varices: a prospective three-center pilot study. Endoscopy. 2006 Jan;38(1):31-5. — View Citation

Escorsell A, Ginès A, Llach J, García-Pagán JC, Bordas JM, Bosch J, Rodés J. Increasing intra-abdominal pressure increases pressure, volume, and wall tension in esophageal varices. Hepatology. 2002 Oct;36(4 Pt 1):936-40. — View 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. — View Citation

Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006 Jan;38(1):36-41. — View Citation

Luca A, Cirera I, García-Pagán JC, Feu F, Pizcueta P, Bosch J, Rodés J. Hemodynamic effects of acute changes in intra-abdominal pressure in patients with cirrhosis. Gastroenterology. 1993 Jan;104(1):222-7. — View Citation

Merli M, Nicolini G, Angeloni S, Rinaldi V, De Santis A, Merkel C, Attili AF, Riggio O. Incidence and natural history of small esophageal varices in cirrhotic patients. J Hepatol. 2003 Mar;38(3):266-72. — View Citation

Pena LR, Cox T, Koch AG, Bosch A. Study comparing oesophageal capsule endoscopy versus EGD in the detection of varices. Dig Liver Dis. 2008 Mar;40(3):216-23. Epub 2007 Dec 21. — View Citation

Saeian K, Staff D, Knox J, Binion D, Townsend W, Dua K, Shaker R. Unsedated transnasal endoscopy: a new technique for accurately detecting and grading esophageal varices in cirrhotic patients. Am J Gastroenterol. 2002 Sep;97(9):2246-9. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of esophageal varices using different screening modalities.		30 days	No
Secondary	Patient tolerability of each screening modality.		1 day	No