AL-AZHAR ASSIUT MEDICAL JOURNAL VOL 13 , NO 1 , JANUREY 2015 SUPPL COMPARATIVE STUDY BETWEEN THE EFFICACY OF REBAMIPIDE, SUCRALFATE AND PANTOPRAZOLE IN TREATMENT OF POST BANDING VARICEAL ULCERS Gamal Mohammad Mohammad Soliman1,Yasser Amer2 and Sadek Mostafa3 Departments of Tropical Medicine1, General Surgery2 and Internal Medicine3 faculty of Medicine - Al- Azhar University ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ ABSTRACT Background: Endoscopic variceal band ligation (EVL) is an effective procedure to control and prevent variceal bleeding in patients with liver cirrhosis. Although EVL has some complications, yet these complications are related to post-EVL ulcers. Few data exist regarding therapy of post-ligation ulcer and treatment been mostly empirical with drugs used for peptic ulcer diseases. Aim of the work: is to compare between the efficacy of rebamipide, sucralfate and pantoprazole in treatment of post banding variceal ulcers. Methods: seventy five patients with oesophageal varices eligible for elective band ligation represented the population of the study. The patients were allocated into three groups; rebamipide group, they received rebamipide 100 mg 3 times daily; pantoprazole group, they received pantoprazole 40 mg/day orally at morning; sucralfate group, they received sucralfate 1gm every 6 hours, for 14 days beginning at the next day of band ligation. Subjects underwent EGD 14 days after banding. Primary outcomes included the size and number of ulcers and the subjects' reports of bleeding, dysphagia, chest pain and vomiting. Results: At follow-up endoscopy, the number of patients with post-band ulcers and size of ulcers were similar in the three groups. However, the number of ulcers for each patient is statistically significant less in rebamipide group when compared to pantoprazole and sucralfate (P < .001). Chest pain, dysphagia and vomiting scores were not significantly different. Dysphagia was by far the most common symptom with no case of bleeding was reported in all patients of the studied groups. Conclusion: Rebamipide is effective in decreasing the post banding complication and reducing size of ulcer as well as the number of ulcers with no significant effect on post banding ulcer formation. Rebamipide can be used routinely in settings of post-EVL as a good alternative to pantoprazole and sucralfate. Key words: Rebamipide, Pantoprazole, Sucralfate, Endoscopic variceal ligation (EVL), Post banding variceal ulcers. INTRODUCTION The behavior of post-ligation ulcer Esophageal varices are the major appears benign because of the instrument design complication of portal hypertension. It is which sucks up mucosa and submucosa leading detected in about 50% of cirrhosis patients, and only to the formation of superficial ulcers. They approximately 5–15% of cirrhosis patients show heal by fibrosis, entrapping only the mucosa, newly formed varices or worsening of varices and submucosal venous channels, leaving the each year (1). muscle layer unaffected(6). Endoscopic variceal ligation (EVL) is a Few data exist regarding adjuvant therapy standard endoscopic procedure in the for EVL. The few groups who have attempted to management of acute variceal bleeding and is determine if adjuvant therapy reduces beneficial in the primary and secondary complications have reported mixed results (7). prophylaxis of esophageal variceal bleeding (2). Rebamipide is one of the gastroprotective drugs EVL is associated with complications such as able to intervene effectively in the process of hemorrhage, chest pain, dysphagia, and ulcer healing and effectively improve the odynophagia due to post-EVL ulcers in the quality of ulcer healing (8).Clinical and esophageal mucosa (3). experimental data demonstrate that rebamipide The rubber band causes hemostasis, accelerates gastric ulcer healing, prevents ulcer thrombosis and sloughing of variceal column; it relapse, and protects gastric mucosa against slough off in the following 24-72 hours, leaving acute injury caused by various noxious agents a shallow ulcer behind(4)that heals within 2–3 (9). Sucralfate has a significant role in weeks, allowing the development of fibrosis in decreasing the rate of occurrence of post- the sub mucosa. In case of premature banding ulcers and as well their size (10). detachment of the rubber band, before variceal Several studies have reported that proton pump thrombosis, marked alterations of the mucosa inhibitors (PPIs) decrease the size of post-EVL can be seen with dilated variceal vessels in ulcers (11, 12). necrotic areas (5). 28 | P a g e Gamal Mohammad Mohammad Soliman et al VOL 13 , NO 1 , JANUREY 2015 SUPPL THE AIM OF THIS STUDY disease, to evaluate the liver function, and to is to compare between the efficacy of detect the impact of liver disease and portal rebamipide, sucralfate and pantoprazole in hypertension on kidney and blood elements]; treatment of post banding variceal ulcers. evaluation of the patients according to Child PATIENTS AND METHODS classification (A, B, C); abdominal ultrasonography and Study Design esophagogastroduodenoscopy (EGD) This study is a randomized controlled trial. Esophagogastroduodenoscopy: Study Setting and time; This study was EGD was done to all patients to evaluate the conducted in the endoscopy units of department following points and then to conduct the process of Tropical Medicine (Al-Hussein and Sayed of esophageal varices band ligation in eligible Galal Uuniversity Hospitals) in the period from patients: A. Esophageal varices: to detect November 2013 to April 2014. number and grade of esophageal varices Inclusion criteria: Patients above the age of 18 according to Westby's grading system according years and below age of 65 years presented for to the size at the gastro-esophageal junction into elective band ligation of esophageal varices. four grades (13): Grade I: Varix is flush with Exclusion criteria: Patients who had been the wall of the esophagus; Grade II: Protrusion subjected to injection sclerotherapy sessions or of the varix, but not more than half way to the having endoscopically confirmed pre-existing center of the lumen; Grade III: Protrusion of oesophageal ulcers. Patient’s ongoing therapy the varix more than half way to the center of the with sucralfate, rebamipide, H2 blockers or lumen; Grade IV: The varices are so large that proton pump inhibitors. The presence of Barret's they meet at the midline. Also, to detect esophagus, isolated fundal varices or peptic presence of risky signs e.g.: cherry red spots and ulcer disease and previous anti-reflux red color sign and number of placed bands. procedures.Diabetic patients, pregnancy, B.Portal hypertensive gastropathy (PHG): It's patients with advanced systemic disease as heart classified, according to consensus statement of failure renal failure or any depleting disease that Baveno IV meeting into; Mild PHG, mosaic- might affect healing process and\or life like pattern; Sever PHG, When mosaic-like expectancy and as well those with suspected pattern is superimposed by any red signs (red malignancy. Allergy to rebamipide, sucralfate, point lesions, cherry red spots, and black brown pantoprazole and finally patients who refuse to spots) (14).C.Other endoscopic finding. participate in the trial. Endoscopic Band Ligation of Oesophageal The Recruited Patients (75) were randomized Varices; the procedure of band ligation was into three groups: conducted using Saeed multiband ligator Group I (n=25) (Rebamipide group): shooter then the patients told to come in the They received rebamipide (Mucosta 100 mg 3 predetermined dates for follow up; one week times daily for 14 days beginning at the next after the banding, two weeks after the first day of band ligation). banding. Group II (n=25) (Pantoprazole group): Post-Procedure Follow up and Evaluation One week after the banding: They received pantoprazole, 40 mg/day orally at Complete history using a special questionnaire morning for 14 days beginning at the next day about: of band ligation). Group III (n=25) (Sucralfate group): 1- Post banding bleeding. This group included 25 patients. They received 2- Chest pain (no, mild, moderate, sever) sucralfate (Gastrofait 1gm every 6 hours for 14 whereas. days beginning at the next day of band ligation). Mild: chest pain that could be Ethical considerations: The objective of the tolerated study was explained to the patients who met the Moderate: could be tolerated in eligibility criteria and they were asked to sign a between. consent form. All the Studied Cases were subjected to the Sever: awaken the patient from following sleep and need medication 3- Dysphagia (no, mild, moderate, sever) • Complete clinical evaluation;laboratory whereas. investigations [To detect the etiology of liver 29 | P a g e AL-AZHAR ASSIUT MEDICAL JOURNAL VOL 13 , NO 1 , JANUREY 2015 SUPPL Mild: dysphagia that could be clarify the possible, expected minor tolerated complications of band ligation with special Moderate: could be tolerated in stress on chest pain, dysphagia and rebleeding. between. Dysphagia was by far the most common symptom occurred in 27 patients (36%) being Sever: couldn’t be tolerated and in; 10 patients (40%) of each pantoprazole and need intervention. sucralfate groups, and less commonly in 4- Vomiting. rebamipide group seven patients (28%). As 5- Compliance of patients in taking. regard bleeding, no