Efficacy of Omeprazole Plus Sucralfate Suspension Compared to Omeprazole Alone for the Prevention of Post-endoscopic Variceal Ligation Ulcer in Cirrhotic Child-Pugh A and B Patients: A Prospective Randomized Controlled Trial

Kawin Tangvoraphonkchai¹, Tanya Apichatvullop¹, Tanita Suttichaimongkol¹, Kookwan Sawadpanich¹, Pisaln Mairiang¹

Affiliation : ¹ Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Background: Post-endoscopic variceal ligation (EVL) ulcers represent a complication following EVL, with potential implications for mortality in cirrhotic patients. Prophylaxis against this complication typically involves either a proton pump inhibitor (PPI) or sucralfate. Limited studies have explored the combination of PPI with sucralfate suspension in the prevention of post-EVL ulcers.
Objective: The present study aimed to assess the efficacy of the combination of omeprazole and sucralfate suspension in comparison to omeprazole alone for preventing post-EVL ulcers in cirrhotic patients classified as Child-Turcotte-Pugh (CTP) A or B.
Materials and Methods: Conducted from March 2019 to December 2022, this prospective, single-center, randomized controlled trial enrolled patients diagnosed liver cirrhosis CTP A or B with esophageal varices. Systematic randomization assigned patients to either the omeprazole plus sucralfate suspension group or the omeprazole alone group. Subsequent esophagogastroduodenoscopy (EGD) was performed two weeks later to evaluate EVL ulceration using Jamwal’s classification and complications.
Results: Out of the 84 initially enrolled patients, 2 in the omeprazole group were lost to follow-up. Intention-to-treat analysis (82 patients) revealed no significant differences between the combination of omeprazole plus sucralfate suspension and omeprazole alone groups in terms of EVL ulcer type (1 (2.4%) vs. 3 (7.5%) in type C, 40 (95.2%) vs. 35 (87.5%) in type D ulcer; p=0.41), EVL ulcer numbers (4.4±2.0 vs. 4±2.1; p=0.43), and percent decreasing of EVL ulcer numbers (33.3±35.8 vs. 35.7±28.8: p=0.47). No statistically significant variations in post-EVL complications were observed between the two treatment groups.
Conclusion: The present study indicates no discernible differences in post-EVL ulcer type, EVL ulcer numbers, percentage reduction in EVL ulcer numbers, and complications between the combination of omeprazole plus sucralfate suspension and omeprazole alone.

Received 29 January 2024 | Revised 29 April 2024| Accepted 7 May 2024
DOI:10.35755/jmedassocthai.2024.S01.S31-S36

Keywords : Post EVL ulcer; Omeprazole; Sucralfate suspension; Jamwal’s classification

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