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## Complete Summary

#### GUIDELINE TITLE

Prevention and management of gastroesophageal varices and variceal
hemorrhage in cirrhosis.

#### BIBLIOGRAPHIC SOURCE(S)

Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W, Practice Guidelines
Committee of the American Association for the Study of Liver Diseases,
Practice Parameters Committee of the American College of
Gastroenterology. Prevention and management of gastroesophageal varices
and variceal hemorrhage in cirrhosis. Hepatology 2007;46(3):922-38.
\[135 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Grace ND. Diagnosis and
treatment of gastrointestinal bleeding secondary to portal hypertension.
Am J Gastroenterol 1997;92:1081-1091.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse (NGC)**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [July 08, 2008, Fluoroquinolones (ciprofloxacin, norfloxacin,
    ofloxacin, levofloxacin, moxifloxacin,
    gemifloxacin)](http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone):
    A BOXED WARNING and Medication Guide are to be added to the
    prescribing information to strengthen existing warnings about the
    increased risk of developing tendinitis and tendon rupture in
    patients taking fluoroquinolones for systemic use.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Gastroesophageal varices and variceal hemorrhage in cirrhosis

#### GUIDELINE CATEGORY

Diagnosis\
Management\
Prevention\
Treatment

#### CLINICAL SPECIALTY

Gastroenterology\
Internal Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide a data-supported approach to the management of patients with
gastroesophageal varices and variceal hemorrhage

#### TARGET POPULATION

Patients with cirrhosis and portal hypertension who have or who are at
risk of developing gastroesophageal varices

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Esophagogastroduodenoscopy (EGD)

2.  Grading of varices

3.  Non-selective beta-blockers (propranolol, nadolol) for prevention of
    variceal hemorrhage

4.  Endoscopic variceal ligation (EVL)

5.  Intravascular volume support and blood transfusion for acute
    gastrointestinal (GI) hemorrhage

6.  Antibiotic prophylaxis (oral norfloxacin, intravenous ciprofloxacin,
    intravenous ceftriaxone) in patients with GI hemorrhage

7.  Pharmacological therapy (somatostatin, octreotide, vapreotide,
    terlipressin) for variceal hemorrhage

8.  EGD with EVL or sclerotherapy for treating hemorrhage

9.  Transjugular intrahepatic portosystemic shunt (TIPS)

10. Balloon tamponade in patients with uncontrollable bleeding

11. Endoscopic variceal obturation for gastric varices using tissue
    adhesives such as cyanoacrylate

12. Secondary prophylaxis to prevent recurrence of variceal hemorrhage

    -   Beta-blocker plus EVL

    -   TIPS

    -   Surgical shunt

13. Referral for transplant

The following interventions were considered but not recommended:
non-selective beta-blockers for the prevention of varices; nitrates
(alone or in combination with beta-blockers), shunt therapy, and
sclerotherapy for primary prophylaxis of variceal hemorrhage.

#### MAJOR OUTCOMES CONSIDERED

-   Incidence of variceal hemorrhage

-   Portal in-flow, portal resistance, and portal pressure

-   Cost-effectiveness of treatment

-   Side effects of treatment

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

These recommendations are based on the following: (1) formal review and
analysis of the recently published world literature on the topic
(Medline search); (2) several consensus conferences among experts; (3)
the American College of Physicians\' Manual for Assessing Health
Practices and Designing Practice Guidelines; (4) guideline policies,
including the American Association for the Study of Liver Diseases\'
Policy Statement on Development and Use of Practice Guidelines and the
American Gastroenterological Association\'s Policy Statement on the Use
of Medical Practice Guidelines; and (5) the authors\' years of
experience caring for patients with cirrhosis and varices.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Level of Evidence**

**Level A**: Data derived from multiple randomized clinical trials or
meta-analyses.

**Level B**: Data derived from a single randomized trial, or
nonrandomized studies.

**Level C**: Only consensus opinion of experts, case studies, or
standard-of-care.

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Practice guidelines for the diagnosis and treatment of gastroesophageal
variceal hemorrhage, endorsed by the American Association for the Study
of Liver Diseases (AASLD), American College of Gastroenterology (ACG),
American Gastroenterological Association (AGA), and American Society of
Gastrointestinal Endoscopy (ASGE), were published in 1997. Since then, a
number of randomized controlled trials have advanced the approach to
managing variceal hemorrhage. Three international consensus conferences
have been held (Baveno III in 2000, Baveno IV in 2005, and an
AASLD/European Association for the Study of Liver Disease (EASL) single
topic conference in 2007) in which experts in the field have evaluated
the changes that have occurred in the understanding of the
pathophysiology and management of gastroesophageal hemorrhage. In this
updated practice guideline the authors have reviewed the randomized
controlled trials and meta-analyses published in the last decade and
have incorporated recommendations made by consensus.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grading System for Recommendations**

**Class I**: Conditions for which there is evidence and/or general
agreement that a given diagnostic evaluation, procedure or treatment is
beneficial, useful, and effective.

**Class II**: Conditions for which there is conflicting evidence and/or
a divergence of opinion about the usefulness/efficacy of a diagnostic
evaluation, procedure or treatment.

**Class IIa:** Weight of evidence/opinion is in favor of
usefulness/efficacy.

**Class IIb**: Usefulness/efficacy is less well established by
evidence/opinion.

**Class III**: Conditions for which there is evidence and/or general
agreement that a diagnostic evaluation/procedure/treatment is not
useful/effective and in some cases may be harmful.

#### COST ANALYSIS

The following cost information is provided:

-   Cost-effective analyses using Markov models have suggested either
    empiric beta-blocker therapy for all patients with cirrhosis or
    screening endoscopy for patients with compensated cirrhosis, and
    universal beta-blocker therapy without screening
    esophagogastroduodenoscopy (EGD) for patients with decompensated
    cirrhosis. Neither of these strategies considers a recent trial
    showing that beta-blockers do not prevent the development of varices
    and are associated with significant side effects, nor do they
    consider endoscopic variceal ligation as an alternative prophylactic
    therapy. Until prospective studies validate these approaches,
    screening EGD is still the recommended approach.

-   A cost-effectiveness study comparing nonselective beta-blockers,
    sclerotherapy, and shunt surgery shows that beta-blockers were the
    only cost-effective form of prophylactic therapy.

-   A recent trial showed that, even though pharmacological (propranolol
    plus nitrates) therapy was less effective than transjugular
    intrahepatic portosystemic shunt (TIPS) in preventing rebleeding, it
    was associated with less encephalopathy, identical survival, and
    more frequent improvement in Child-Pugh class with lower costs than
    TIPS. Therefore, TIPS should not be used as a first-line treatment,
    but as a rescue therapy for patients who have failed pharmacological
    plus endoscopic treatment.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This guideline was produced in collaboration with the Practice
Guidelines Committee of the American Association for the Study of Liver
Diseases and the Practice Parameters Committee of the American College
of Gastroenterology. These committees provided extensive peer review of
the manuscript.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The class of recommendations (I, II, IIa, IIb, III) and the levels of
evidence (A--C) are defined at the end of the \"Major Recommendations.\"

**Diagnosis of Varices and Variceal Hemorrhage**

1.  Screening esophagogastroduodenoscopy (EGD) for the diagnosis of
    esophageal and gastric varices is recommended when the diagnosis of
    cirrhosis is made (**Class IIa, Level C**).

2.  On EGD, esophageal varices should be graded as small or large
    (\>5 mm) with the latter classification encompassing medium-sized
    varices when 3 grades are used (small, medium, large). The presence
    or absence of red signs (red wale marks or red spots) on varices
    should be noted (**Class IIa, Level C**).

**Management Recommendations**

**Patients with Cirrhosis and No Varices**

3.  In patients with cirrhosis who do not have varices, nonselective
    beta-blockers cannot be recommended to prevent their development
    (**Class III, Level B**).

4.  In patients who have compensated cirrhosis and no varices on the
    initial EGD, it should be repeated in 3 years (**Class I, Level
    C**). If there is evidence of hepatic decompensation, EGD should be
    done at that time and repeated annually (**Class I, Level C**).

**Patients with Cirrhosis and Small Varices That Have Not Bled**

5.  In patients with cirrhosis and small varices that have not bled but
    have criteria for increased risk of hemorrhage (Child B/C \[see
    Table 2 in the original guideline document for Child-Pugh
    classification of the severity of cirrhosis\] or presence of red
    wale marks on varices), nonselective beta-blockers should be used
    for the prevention of first variceal hemorrhage (**Class IIa, Level
    C**).

6.  In patients with cirrhosis and small varices that have not bled and
    have no criteria for increased risk of bleeding, beta-blockers can
    be used, although their long-term benefit has not been established
    (**Class III, Level B**).

7.  In patients with small varices that have not bled and who are not
    receiving beta-blockers, EGD should be repeated in 2 years (**Class
    I, Level C**). If there is evidence of hepatic decompensation, EGD
    should be done at that time and repeated annually (**Class I, Level
    C**). In patients with small varices who receive beta-blockers, a
    follow-up EGD is not necessary.

**Patients with Cirrhosis and Medium/Large Varices That Have Not Bled**

8.  In patients with medium/large varices that have not bled but have a
    high risk of hemorrhage (Child B/C \[see Table 2 in the original
    guideline document\] [or]{.underline} variceal red wale markings on
    endoscopy), nonselective beta-blockers (propranolol or nadolol) or
    EVL may be recommended for the prevention of first variceal
    hemorrhage (**Class I, Level A**).

9.  In patients with medium/large varices that have not bled and are not
    at the highest risk of hemorrhage (Child A patients \[see Table 2 in
    the original guideline document\] and no red signs), nonselective
    beta-blockers (propranolol, nadolol) are preferred and EVL should be
    considered in patients with contraindications or intolerance or
    non-compliance to beta-blockers (**Class I, Level A**).

10. If a patient is placed on a nonselective beta-blocker, it should be
    adjusted to the maximal tolerated dose; follow-up surveillance EGD
    is unnecessary. If a patient is treated with EVL, it should be
    repeated every 1-2 weeks until obliteration with the first
    surveillance EGD performed 1 to 3 months after obliteration and then
    every 6 to 12 months to check for variceal recurrence (**Class I,
    Level C**).

11. Nitrates (either alone or in combination with beta-blockers), shunt
    therapy, or sclerotherapy should not be used in the primary
    prophylaxis of variceal hemorrhage (**Class III, Level A**).

**Patients with Cirrhosis and an Acute Episode of Variceal Hemorrhage**

12. Acute gastrointestinal (GI) hemorrhage in a patient with cirrhosis
    is an emergency that requires prompt attention with intravascular
    volume support and blood transfusions, being careful to maintain a
    hemoglobin of \~8 g/dL (**Class I, Level B**).

13. Short-term (maximum 7 days) antibiotic prophylaxis should be
    instituted in any patient with cirrhosis and GI hemorrhage (**Class
    I, Level A**). Oral norfloxacin (400 mg twice a day \[BID\]) or
    intravenous ciprofloxacin (in patients in whom oral administration
    is not possible) is the recommended antibiotic (**Class I, Level
    A**). In patients with advanced cirrhosis intravenous ceftriaxone (1
    g/day) may be preferable particularly in centers with a high
    prevalence of quinolone-resistant organisms (**Class I, Level B**).

14. Pharmacological therapy (somatostatin or its analogues octreotide
    and vapreotide; terlipressin) should be initiated as soon as
    variceal hemorrhage is suspected and continued for 3 to 5 days after
    diagnosis is confirmed (**Class I, Level A**).

15. EGD, performed within 12 hours, should be used to make the diagnosis
    and to treat variceal hemorrhage, either with EVL or sclerotherapy
    (**Class I, Level A**).

16. Transjugular intrahepatic portosystemic shunt (TIPS) is indicated in
    patients in whom hemorrhage from esophageal varices cannot be
    controlled or in whom bleeding recurs despite combined
    pharmacological and endoscopic therapy (**Class I, Level C**).

17. Balloon tamponade should be used as a temporizing measure (maximum
    24 hours) in patients with uncontrollable bleeding for whom a more
    definitive therapy (e.g., TIPS or endoscopic therapy) is planned
    (**Class I, Level B**).

**Gastric Varices**

18. In patients who bleed from gastric fundal varices, endoscopic
    variceal obturation using tissue adhesives such as cyanoacrylate is
    preferred, where available. Otherwise, EVL is an option (**Class I,
    Level B**).

19. A TIPS should be considered in patients in whom hemorrhage from
    fundal varices cannot be controlled or in whom bleeding recurs
    despite combined pharmacological and endoscopic therapy (**Class I,
    Level B**).

**Patients with Cirrhosis Who Have Recovered from Acute Variceal
Hemorrhage**

20. Patients with cirrhosis who survive an episode of active variceal
    hemorrhage should receive therapy to prevent recurrence of variceal
    hemorrhage (secondary prophylaxis) (**Class I, Level A**).

21. Combination of nonselective beta-blockers plus EVL is the best
    option for secondary prophylaxis of variceal hemorrhage (**Class I,
    Level A**).

22. The nonselective beta-blocker should be adjusted to the maximal
    tolerated dose. EVL should be repeated every 1-2 weeks until
    obliteration with the first surveillance EGD performed 1 to 3 months
    after obliteration and then every 6 to 12 months to check for
    variceal recurrence (**Class I, Level C**).

23. TIPS should be considered in patients who are Child A or B (see
    Table 2 in the original guideline document) who experience recurrent
    variceal hemorrhage despite combination pharmacological and
    endoscopic therapy. In centers where the expertise is available,
    surgical shunt can be considered in Child A patients (**Class I,
    Level A**).

24. Patients who are otherwise transplant candidates should be referred
    to a transplant center for evaluation (**Class I, Level C**).

**Definitions**:

**Level of Evidence**

**Level A**: Data derived from multiple randomized clinical trials or
meta-analyses.

**Level B**: Data derived from a single randomized trial, or
nonrandomized studies.

**Level C**: Only consensus opinion of experts, case studies, or
standard-of-care.

**Grading System for Recommendations**

**Class I**: Conditions for which there is evidence and/or general
agreement that a given diagnostic evaluation, procedure or treatment is
beneficial, useful, and effective.

**Class II**: Conditions for which there is conflicting evidence and/or
a divergence of opinion about the usefulness/efficacy of a diagnostic
evaluation, procedure or treatment.

**Class IIa**: Weight of evidence/opinion is in favor of
usefulness/efficacy.

**Class IIb**: Usefulness/efficacy is less well established by
evidence/opinion.

**Class III**: Conditions for which there is evidence and/or general
agreement that a diagnostic evaluation/procedure/treatment is not
useful/effective and in some cases may be harmful.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is specifically stated for each
recommendation (see \"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate prevention and management of gastroesophageal varices and
variceal hemorrhage in cirrhosis

#### POTENTIAL HARMS

-   The most common side effects related to beta-blockers in cirrhosis
    are lightheadedness, fatigue, and shortness of breath.

-   Beta-blockers should not be used in the acute setting as they will
    decrease blood pressure and will blunt a physiologic increase in
    heart rate associated with bleeding.

-   Adverse events reported with endoscopic variceal ligation (EVL)
    include bleeding from ligation-induced esophageal ulcers and
    overtube-induced esophageal perforation. This last complication is
    currently less likely to occur given the use of multi-band ligation
    devices that minimize the use of overtubes for band placement.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Relative contraindications to the use of beta-blockers include asthma,
insulin-dependent diabetes (with episodes of hypoglycemia), and
peripheral vascular disease.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Intended for use by healthcare providers, these recommendations suggest
preferred approaches to the diagnostic, therapeutic, and preventive
aspects of care. As with other practice guidelines, this guideline is
not intended to replace clinical judgment but rather to provide general
guidelines applicable to the majority of patients. They are intended to
be flexible, in contrast to standards of care, which are inflexible
policies designed to be followed in every case.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Personal Digital Assistant (PDA) Downloads

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness\
Staying Healthy

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W, Practice Guidelines
Committee of the American Association for the Study of Liver Diseases,
Practice Parameters Committee of the American College of
Gastroenterology. Prevention and management of gastroesophageal varices
and variceal hemorrhage in cirrhosis. Hepatology 2007;46(3):922-38.
\[135 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1997 (revised 2007 Sep)

#### GUIDELINE DEVELOPER(S)

American Association for the Study of Liver Diseases - Private Nonprofit
Research Organization\
American College of Gastroenterology - Medical Specialty Society

#### SOURCE(S) OF FUNDING

American Association for the Study of Liver Disease

#### GUIDELINE COMMITTEE

Practice Guidelines Committee of the American Association for the Study
of Liver Diseases

Practice Parameters Committee of the American College of
Gastroenterology

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Guadalupe Garcia-Tsao, Section of Digestive Diseases, Yale
University School of Medicine and VACT Healthcare System, New Haven, CT;
Arun J. Sanyal, Division of Gastroenterology, Virginia Commonwealth
University Medical Center, Richmond , VA; Norman D. Grace, Division of
Gastroenterology, Brigham and Women\'s Hospital, Boston, MA; William
Carey, Department of Gastroenterology and Hepatology, The Cleveland
Clinic, Cleveland, OH

*American Association for the Study of Liver Disease Practice Guidelines
Committee*: Margaret C. Shuhart, MD, MS (Committee Chair); Gary L.
Davis, MD (Board Liaison); Kiran Bambha, MD; Andres Cardenas, MD, MMSc;
Stanley M. Cohen, MD; Timothy J. Davern, MD; Steven L. Flamm, MD;
Steven-Huy B. Han, MD; Charles D. Howell, MD; David R. Nelson, MD; K.
Rajender Reddy, MD; Bruce A. Runyon, MD; John B. Wong, MD; Colina Yim,
RN; and Nizar N. Zein, MD

*American College of Gastroenterology Practice Parameters Committee*:
John Inadomi, MD, FACG (Committee Chair); Darren Baroni, MD; David
Bernstein, MD, FACG; William Brugge, MD, FACG; Lin Chang, MD; William
Chey, MD, FACG; John Cunningham, MD, FACG; Kenneth DeVault, MD, FACG;
Steven Edmundowicz, MD; Ronnie Fass, MD, FACG; Kelvin Hornbuckle, MD;
Costas Kefalas, MD, FACG; Timothy Koch, MD, FACG; Jenifer Lehrer, MD;
Anthony Lembo, MD; John O\'Brien, MD; John Papp, Sr., MD, MACG; Henry
Parkman, MD, FACG; Albert Roach, PharmD, FACG; Richard Sampliner, MD,
MACG; Amnon Sonnenberg, MD, MSc, FACG; Subbaramiah Sridhar, MD, FACG;
Miguel Valdovinos, MD; John Vargo, MD, MPH, FACG; Marcelo Vela, MD; and
Nizar Zein, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Potential conflict of interest: Nothing to report

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Grace ND. Diagnosis and
treatment of gastrointestinal bleeding secondary to portal hypertension.
Am J Gastroenterol 1997;92:1081-1091.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Association for the Study of Liver Diseases Web
site](https://www.aasld.org/eweb/docs/practiceguidelines/VariesinGuidelinesSept2007FT.pdf).

Print copies: Available from the American Association for the Study of
Liver Diseases, 1729 King Street, Suite 200; Alexandria, VA 22314;
Phone: 703-299-9766; Web site: [www.aasld.org](http://www.aasld.org/);
e-mail: <aasld@aasld.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

This guideline is available as a Personal Digital Assistant (PDA)
download via the APPRISOR™ Document Viewer from
[www.apprisor.com](http://www.apprisor.com/).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI Institute on September 18, 2007. The
information was verified by the guideline developer on October 10, 2007.
This summary was updated by ECRI Institute on July 28, 2008 following
the U.S. Food and Drug Administration advisory on fluoroquinolone
antimicrobial drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the American Association for the Study of Liver Diseases\' copyright
restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008