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Esophageal VaricesPhase 3NCT00911131

Enhancing Detection of Small Esophageal Varices by PillCam ESO

A Phase 3 study testing Capsule endoscopy (PillCam ESO), EGD and Capsule endoscopy (PillCam ESO) with abdominal binder in people with Esophageal Varices, run by Medical College of Wisconsin.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Varices
What is being tested?
Capsule endoscopy (PillCam ESO), EGD and Capsule endoscopy (PillCam ESO) with abdominal binder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • dysphagia
  • Zenker's diverticulum
  • pregnancy
  • esophageal stricture
  • gastric or intestinal obstruction
  • multiple abdominal surgeries
Show all 13Show fewer
  • 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.

About this study

Official title: 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.
Read the 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.

Being tested
Capsule endoscopy (PillCam ESO), EGD, Capsule endoscopy (PillCam ESO) with abdominal binder
Keywords
Small grade esophageal varices, capsule endoscopy, PillCam ESO, abdominal binder
Medical subject headings
Esophageal and Gastric Varices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capsule endoscopy (PillCam ESO)Device

    Also called 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.

  • EGDProcedure or surgery

    Also called Esophagoduodenoscopy

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

  • Capsule endoscopy (PillCam ESO) with abdominal binderDevice

    Also called PillCam ESO

    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.

Study groups in NCT00911131
Study groupRoleWhat they receive
Screening esophagoduodenoscopy (EGD)Active comparatorEGD 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.
Receives: Procedure: EGD
Capsule EndoscopyActive comparatorThe 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).
Receives: Device: Capsule endoscopy (PillCam ESO)
Capsule Endoscopy with abdominal binderActive comparatorBefore 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.
Receives: Device: Capsule endoscopy (PillCam ESO) with abdominal binder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection rate of esophageal varices using different screening modalities.

    Measured: 30 days

Secondary outcomes (1)

  1. Patient tolerability of each screening modality.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)

Why it stopped: Loss of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911131
Sponsor's protocol ID
PRO 8503
Status last verified
Jun 2015
First submitted
29 May 2009
Last updated
19 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 10643630

  • 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.

    PubMed 7026343

  • 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.

    PubMed 9731585

  • 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.

    PubMed 11097497

  • 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.

    PubMed 10343210

  • 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.

    PubMed 12358240

  • 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.

    PubMed 16429352

  • 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.

    PubMed 16429353

  • 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.

    PubMed 18082473

  • 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.

    PubMed 18435461

  • 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.

    PubMed 12586291

  • 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.

    PubMed 8419245

  • 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.

    PubMed 12297841

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capsule endoscopy (PillCam ESO), EGD and Capsule endoscopy (PillCam ESO) with abdominal binder in people with Esophageal Varices, run by Medical College of Wisconsin.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection rate of esophageal varices using different screening modalities. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911131, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.

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