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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”


Endoscopic Sclerotherapy Should Be Second-Line Treatment for Variceal Bleeding  CME

http://www.medscape.com/viewarticle/456385

News Author: Laurie Barclay, MD
CME Author: Bernard M. Sklar, MD, MS

Authors and Disclosures

To earn CME credit, read the news brief, the paragraphs that follow, and answer the questions below.

Release Date: May 29, 2003; Valid for credit through May 29, 2004

May 29, 2003 — A Cochrane meta-analysis reported in the May issue of Gastroenterology suggests that endoscopic sclerotherapy should be used to control variceal bleeding only when pharmacologic therapy fails.

"Available evidence does not support emergency sclerotherapy as the first-line treatment of variceal bleeding in cirrhosis when compared with vasoactive drugs, which control bleeding in 83% of patients," write Gennaro D'Amico, MD, from Ospedale V Cervello in Palermo, Italy, and colleagues. "Therefore, endoscopic therapy might be added only in pharmacologic treatment failures."

Using MEDLINE (1968-2002), EMBASE (1986-2002), and the Cochrane Library (2002), the investigators identified 15 randomized controlled trials comparing sclerotherapy with vasopressin (with or without nitroglycerin), terlipressin, somatostatin, or octreotide for variceal bleeding in cirrhosis.

Although sclerotherapy was superior to vasopressin for the control of bleeding in a single trial, this trial was flawed by a potential detection bias. Otherwise, sclerotherapy was not superior to vasopressin for rebleeding, blood transfusions, death, or adverse events, and it was not superior to terlipressin, somatostatin, or octreotide for any outcome.

  



Adverse events were significantly more common with sclerotherapy than with somatostatin. Using a predefined sensitivity analysis that combined all of the trials regardless of the control treatment, the risk differences between sclerotherapy and control were -0.03 (95% confidence interval [CI], -0.06 to 0.01) for failure to control bleeding, -0.035 (95% CI, -0.07 to 0.008) for mortality, and 0.08 (95% CI, 0.02 to 0.14) for adverse events.

The difference in mortality risk was -0.01 (95% CI, -0.07 to 0.04) in good-quality trials and -0.08 (95% CI, -0.14 to -0.02) in poor-quality trials. Six deaths were attributed to sclerotherapy, compared with none in the vasoactive groups.

Although there were methodological problems in most of the trials, the authors suggested that these problems tended to exaggerate the beneficial effects of sclerotherapy, particularly on survival, and to minimize adverse events.

"Adding endoscopic therapy only in failures of medical treatment could save a large proportion of emergency endoscopic treatments and related complications," the authors write, noting that this approach could also reduce healthcare costs. "It remains to be assessed whether the immediate combination therapy is superior to endoscopic therapy added to vasoactive drugs only when the pharmacologic intervention fails. If the delayed combination is as equally effective as the immediate combination, then a considerable reduction of adverse events associated with emergency endoscopic therapy might be expected. We suggest testing this hypothesis in [a randomized clinical trial]."

Gastroenterology. 2003;124:1277-1291

Learning Objectives

Upon completion of this activity, participants will be able to:

  • Discuss the etiology, prevalence, and treatment of bleeding esophageal varices.
  • Describe the results of a Cochrane meta-analysis comparing emergency sclerotherapy with pharmacologic treatment for bleeding esophageal varices.

Clinical Context

Bleeding from esophageal varices is one of the most common and severe complications of hepatic cirrhosis. According to the textbook Schwartz Principles of Surgery, bleeding esophageal varices or gastric varices in the presence of liver disease account for about 10% of all upper gastrointestinal bleeding and are a life-threatening situation with a high mortality rate.

Alcoholism is the most common cause of portal hypertension, but hepatitis B and hepatitis C are increasingly seen as causes of posthepatic cirrhosis. Hepatocellular carcinoma may complicate hepatitis B and result in sudden onset of portal hypertension with portal vein thrombosis and bleeding. In patients with cirrhosis and portal hypertension, variceal hemorrhage accounts for 50% to 75% of all episodes of upper gastrointestinal bleeding.

Variceal hemorrhage usually is precipitated by ulceration of the varix secondary to reflux esophagitis or increased pressure within the varix. Recurrent bleeding and mortality follow the inability of the failing liver to synthesize reparative proteins and proteins necessary for coagulation.

According to the authors of the Gastroenterology study, sclerotherapy of esophageal varices is widely used and has often been recommended as the first-choice treatment of variceal bleeding in cirrhosis. This recommendation has persisted in spite of studies showing that vasoactive drugs may stop bleeding in most patients and the presence of several randomized controlled trials comparing emergency sclerotherapy with vasoactive drugs yielding inconsistent results. Bañares and colleagues, in the March 2002 issue of Hepatology, reported a meta-analysis showing that the efficacy of emergency endoscopic sclerotherapy or banding ligation of varices is significantly improved when combined with somatostatin or its derivatives, although the combination did not improve survival.

Emergency endoscopic therapy requires a skilled endoscopist, and sclerotherapy is associated with adverse events in 10% to 20% of patients and with serious adverse events in 7%. The efficacy of emergency banding ligation and its complications are poorly defined because that procedure was assessed only in a few randomized clinical trials for the long-term prevention of variceal rebleeding.

  



Because either endoscopic or pharmacologic therapy have been reported to control bleeding in 75% to 90% of patients, initial treatment with the more effective therapy and their combination only in failures of initial treatment might be a more logical approach than their immediate combination.

For these reasons, the authors performed a systematic review to assess the efficacy and adverse events of emergency sclerotherapy compared with vasoactive drugs for acute variceal bleeding in cirrhotic patients.

Study Highlights

The study in Gastroenterology updates the November 2002 Cochrane Review, "Emergency sclerotherapy or band ligation combined with vasoactive drugs for bleeding esophageal varices in cirrhosis," by adding three additional randomized clinical trials.

This is a meta-analysis comparing emergency sclerotherapy with pharmacologic treatment. The authors searched MEDLINE (1968-2002), EMBASE (1986-2002),and the Cochrane Library (2002) to retrieve randomized controlled trials comparing sclerotherapy with vasopressin (with or without nitroglycerin), terlipressin, somatostatin, or octreotide for variceal bleeding in cirrhosis.

Outcome measures were failure to control bleeding, rebleeding, blood transfusions, adverse events, and mortality. Fifteen trials were identified.

The study showed that sclerotherapy was not superior to terlipressin, somatostatin, or octreotide for any outcome nor to vasopressin for rebleeding, blood transfusions, death, or adverse events; it was superior to vasopressin for the control of bleeding in a single trial "flawed by a potential detection bias." Sclerotherapy was associated with significantly more adverse events than somatostatin.

The authors conclude that "available evidence does not support emergency sclerotherapy as the first-line treatment of variceal bleeding in cirrhosis when compared with vasoactive drugs, which control bleeding in 83% of patients." They suggest that "endoscopic therapy might be added only in pharmacologic treatment failures."

Pearls for Practice

  • Emergency sclerotherapy should not be the first-line treatment of variceal bleeding in cirrhosis.
  • In the treatment of variceal bleeding, endoscopic therapy should be added only when vasoactive treatment fails.

Post Test

1.

Which of the following answers is correct?

 

a.

According to Schwartz Principles of Surgery, bleeding esophageal varices or gastric varices in the presence of liver disease account for about 25% of all upper gastrointestinal bleeding

 

b.

According to Schwartz Principles of Surgery, in patients with cirrhosis and portal hypertension, variceal hemorrhage accounts for 50% to 75% of all episodes of upper gastrointestinal bleeding

 

c.

According to the authors of the current paper, the use of sclerotherapy as the first-choice treatment of variceal bleeding of cirrhosis is based on numerous randomized clinical trials

 

d.

According to the authors of the current paper, emergency endoscopic sclerotherapy for bleeding esophageal varices is associated with adverse events in 5% to 10% of patients and with serious adverse events in 2%

 

 

 

 

2.

According to the Gastroenterology study, in the treatment of acute esophageal variceal bleeding, which of the following statements is correct?

 

a.

Endoscopic sclerotherapy is superior to terlipressin, somatostatin, and octreotide

 

b.

Endoscopic sclerotherapy is associated with significantly fewer adverse events than somatostatin

 

c.

Emergency endoscopic sclerotherapy should not be the first-line treatment of variceal bleeding in cirrhosis

 

d.

The preferred initial treatment should be a combination of sclerotherapy and a vasoactive agent