Enhancing Detection of Small Esophageal Varices by PillCam ESO

NCT00911131 | Withdrawn Phase 3 DMC

• 1 other identifier: PRO 8503
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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:

1. 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. 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.

Conditions

Esophageal Varices

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Detection rate of esophageal varices using different screening modalities.

  30 days

Secondary Outcomes (1)

• Patient tolerability of each screening modality.

  1 day

Study Arms (3)

Screening esophagoduodenoscopy (EGD)

ACTIVE COMPARATOR

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.

Procedure: EGD

Capsule Endoscopy

ACTIVE COMPARATOR

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)

Capsule Endoscopy with abdominal binder

ACTIVE COMPARATOR

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

Interventions

Capsule endoscopy (PillCam ESO) DEVICE

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.

Also known as: PillCam ESO

Capsule Endoscopy

EGD PROCEDURE

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

Also known as: Esophagoduodenoscopy

Screening esophagoduodenoscopy (EGD)

Capsule endoscopy (PillCam ESO) with abdominal binder DEVICE

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.

Also known as: PillCam ESO

Capsule Endoscopy with abdominal binder

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Medtronic - MITG: collaborator

Related Publications (13)

• D'Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis. 1999;19(4):475-505. doi: 10.1055/s-2007-1007133.

  PMID: 10643630 BACKGROUND

• 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.

  PMID: 7026343 BACKGROUND

• 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.

  PMID: 9731585 BACKGROUND

• 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. doi: 10.1016/s0168-8278(00)80320-7. No abstract available.

  PMID: 11097497 BACKGROUND

• 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.

  PMID: 10343210 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2002.05906.x.

  PMID: 12358240 BACKGROUND

• 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. doi: 10.1055/s-2005-921189.

  PMID: 16429352 BACKGROUND

• 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. doi: 10.1055/s-2006-924975.

  PMID: 16429353 BACKGROUND

• 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. doi: 10.1016/j.dld.2007.10.022. Epub 2007 Dec 21.

  PMID: 18082473 BACKGROUND

• 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.

  PMID: 18435461 BACKGROUND

• 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. doi: 10.1016/s0168-8278(02)00420-8.

  PMID: 12586291 BACKGROUND

• Luca A, Cirera I, Garcia-Pagan JC, Feu F, Pizcueta P, Bosch J, Rodes J. Hemodynamic effects of acute changes in intra-abdominal pressure in patients with cirrhosis. Gastroenterology. 1993 Jan;104(1):222-7. doi: 10.1016/0016-5085(93)90855-7.

  PMID: 8419245 BACKGROUND

• Escorsell A, Gines A, Llach J, Garcia-Pagan JC, Bordas JM, Bosch J, Rodes J. Increasing intra-abdominal pressure increases pressure, volume, and wall tension in esophageal varices. Hepatology. 2002 Oct;36(4 Pt 1):936-40. doi: 10.1053/jhep.2002.35817.

  PMID: 12297841 BACKGROUND

MeSH Terms

Conditions

Esophageal and Gastric Varices

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kia Saeian, MD

  Medical College of Wisconsin

  STUDY DIRECTOR

• Mukund Venu, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 1, 2009
• Last Updated: June 19, 2015

Record last verified: 2015-06