OBJECTIVE: Comparison of the safety and efficacy of endoscopic sclerotherapy and ligation for the treatment of bleeding esophageal varices. DESIGN: Randomized, controlled trial. SETTING:An urban county hospital. PATIENTS: Patients with clinically severe bleeding from esophageal varices. INTERVENTION: A total of 77 patients were randomly assigned to receive sclerotherapy or ligation at the initial endoscopic examination. Treatment was repeated weekly until variceal obliteration was achieved. After eradication, patients had endoscopic examinations every 3 months or for any episode of rebleeding. Recurrent varices were treated with the originally assigned form of endoscopic therapy. MEASUREMENTS: Patients were assessed for further bleeding, for transfusion requirements, for time in hospital, for variceal eradication, for number of treatment sessions required, for complications, for treatment failure, and for risk of death. RESULTS:Rebleeding tended to be less frequent with ligation than with sclerotherapy: 10 of 38 (26%) compared with 17 of 39 (44%) (difference, 17% [95 CI, -4% to 38%]), but results in the two groups were comparable for blood transfusions, for length of hospital stay, and for risk of death. Comparison of Kaplan-Meier estimates of time to rebleeding and death showed no statistical differences between treatments. Complications were less common in the ligation group: fewer patients in the ligation group had esophageal strictures (0 of 38 compared with 13 of 39 [33%]; P < 0.001) and had complicated esophageal ulcers (1 of 38 [2.6%] compared with 6 of 39 [15%]; P = 0.11). In addition, fewer ligation treatments were required to achieve variceal eradication (4.1 +/- 0.3 compared with 6.2 +/- 0.4; P < 0.001). CONCLUSION:Endoscopic ligation causes statistically fewer local complications than sclerotherapy and achieves variceal eradication more rapidly. Ligation is a viable alternative to sclerotherapy and may have some advantages as a treatment for bleeding esophageal varices.
RCT Entities:
OBJECTIVE: Comparison of the safety and efficacy of endoscopic sclerotherapy and ligation for the treatment of bleeding esophageal varices. DESIGN: Randomized, controlled trial. SETTING: An urban county hospital. PATIENTS: Patients with clinically severe bleeding from esophageal varices. INTERVENTION: A total of 77 patients were randomly assigned to receive sclerotherapy or ligation at the initial endoscopic examination. Treatment was repeated weekly until variceal obliteration was achieved. After eradication, patients had endoscopic examinations every 3 months or for any episode of rebleeding. Recurrent varices were treated with the originally assigned form of endoscopic therapy. MEASUREMENTS: Patients were assessed for further bleeding, for transfusion requirements, for time in hospital, for variceal eradication, for number of treatment sessions required, for complications, for treatment failure, and for risk of death. RESULTS: Rebleeding tended to be less frequent with ligation than with sclerotherapy: 10 of 38 (26%) compared with 17 of 39 (44%) (difference, 17% [95 CI, -4% to 38%]), but results in the two groups were comparable for blood transfusions, for length of hospital stay, and for risk of death. Comparison of Kaplan-Meier estimates of time to rebleeding and death showed no statistical differences between treatments. Complications were less common in the ligation group: fewer patients in the ligation group had esophageal strictures (0 of 38 compared with 13 of 39 [33%]; P < 0.001) and had complicated esophageal ulcers (1 of 38 [2.6%] compared with 6 of 39 [15%]; P = 0.11). In addition, fewer ligation treatments were required to achieve variceal eradication (4.1 +/- 0.3 compared with 6.2 +/- 0.4; P < 0.001). CONCLUSION: Endoscopic ligation causes statistically fewer local complications than sclerotherapy and achieves variceal eradication more rapidly. Ligation is a viable alternative to sclerotherapy and may have some advantages as a treatment for bleeding esophageal varices.