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Therapeutics

Sclerotherapy and ligation were equally effective for bleeding varices in patients with cirrhosis but ligation had lower rates of death and complications

ACP J Club. 1992 Nov-Dec;117:67. doi:10.7326/ACPJC-1992-117-3-067


Source Citation

Stiegmann GV, Goff JS, Michaletz-Onody PA, et al. Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N Engl J Med. 1992 Jun 4;326:1527-32.


Abstract

Objective

To compare sclerotherapy with endoscopic ligation for treatment of bleeding esophageal varices in patients with cirrhosis.

Design

Randomized controlled trial with annual interim analyses.

Setting

4 tertiary care medical centers.

Patients

Adults ≥ 18 years old who had cirrhosis with actively bleeding or recently bleeding esophageal varices were included. Excluded were patients with contraindications to endoscopy, previous endoscopic or surgical treatment for esophageal varices, gastric fundal varices, symptoms of esophageal dysfunction, or life expectancy < 12 months. 230 patients were screened, and 130 were randomized (mean age, 52 y; 104 men).

Intervention

65 patients had endoscopic sclerotherapy. Aliquots of a 2-mL solution of 1% sodium tetradecyl sulfate were injected into varices with a 25-gauge needle. No more than 20 mL was used at each session. 64 patients had endoscopic ligation. Varices were individually ligated with an endoscopic ligating device using a single elastic "O" ring and overtube. All varices were ligated at least once per treatment. Bleeding varices were treated before nonbleeding varices, and treatments were repeated as needed until all varices were eradicated. Groups had similar supportive care and monitoring after treatment. Mean follow-up was 10 months for 68% of patients who survived or were followed for > 30 days.

Main outcome measures

Endoscopies were done as needed to eradicate varices and thereafter were done every 3 months. Mortality, complications, bleeding, rebleeding, and number of treatments were measured.

Main results

The study closed after the 2-year interim analysis showed differences in mortality and complication rates. Both treatments were equally effective for controlling active bleeding, complete eradication at < 30 days, and number of treatment failures. 29 patients (45%) receiving sclerotherapy died compared with 18 (28%) receiving ligation ({95% CI for the difference of 17%, 0.1% to 33%}*, P = 0.04). Patients in the ligation group had a lower complication rate (2% vs 22% {CI for the difference, 10% to 30%}*, P < 0.001), and had a trend toward fewer treatments (4 vs 5, P = 0.06) and less rebleeding (36% vs 48%, P = 0.07) than patients in the sclerotherapy group.

Conclusions

Endoscopic sclerotherapy and ligation were equally effective in controlling actively bleeding varices in patients with cirrhosis. Patients receiving ligation had lower death and complication rates.

Source of funding: Not stated.

For article reprint: Dr. G.V. Stiegmann, C-313, University of Colorado Health Sciences Center, 4200 East 9th Avenue, Denver, CO 80262, USA.

*Numbers calculated from data in article.


Commentary

The study by Stiegmann and colleagues shows that endoscopic ligation of esophageal varices is at least as effective as sclerotherapy in preventing rebleeding from varices and is safer. The incidence of serious complications, namely, esophageal stricture or perforation, pneumonia, pleural effusions, and bacterial peritonitis, was much lower in the ligation group. This may account for the decreased mortality rate in the ligation group. More than half of the deaths in each group occurred within 30 days of entering the study, an expected finding in these patients. The complication rate in the sclerotherapy group is similar to that in other published studies (1) and is consistent with the experience in most tertiary care centers. That variceal ligation should have a lower rate of esophageal stricture and perforations than sclerotherapy is expected. The injection of up to 20 mL of a tissue-damaging sclerosant into the esophageal wall typically produces ulcerations and scarring at the injection site. The required use of a 20-mm diameter overtube with ligation may prevent tracheal aspiration during the procedure and therefore decrease the incidence of aspiration pneumonia.

Similarly, sclerotherapy is known to cause transient bacteremia that may precipitate bacterial peritonitis. The disadvantage of ligation is the required use of a large overtube; it is uncomfortable and more difficult to insert than the endoscope. The development of esophageal ligation is an advance in the treatment of patients who have bled from esophageal varices and should now be considered the preferred treatment.

Marshall M. Kaplan
Tufts University School of MedicineBoston, Massachusetts, USA


Reference

1. The Veterans Affairs Cooperative Variceal Sclerotherapy Group. Prophylactic sclerotherapy for esophageal varices in men with alcoholic liver disease: a randomized, single-blind, multicenter clinical trial. N Engl J Med. 1991;324:1779-84.