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1. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding Wen-Chi Chen, Tsung Chieh yang, Pei Chang Lee, Yen po Wang, Ming Chih Hou, Fa Yauh Lee Taken from The American Journal of Gastroenterology Journal Reading

2. INTRODUCTION 2

3. LIVER CIRRHOSIS Liver cirrhosis (LC) often causes portal hypertension by changing the structure of hepatic tissue and blood flow in the liver Portal hypertension is strongly associated with esophageal varices (EV) It is diagnosed when the hepatic venous pressure gradient (HVPG) is >5 mm Hg Clinically significant portal hypertension (CSPH) is established at an HVPG >10 mmHg  3

4. ESOPHAGEAL VARICES The current gold standard for identifying EV continues to be endoscopy Endoscopy is an invasive procedure that is expensive, time-consuming, and often uncomfortable for the patient, and repeated endoscopies are associated with adverse effects such as aspiration, perforation, and bacteremia 4

5. HEPATIC VENOUS PRESSURE Measurement of HVPG is the gold standard method for ascertaining the presence and significance of PH, but because it is invasive and not widely available, it is difficult to perform in daily clinical practice 5 Reiberger T. The value of liver and spleen stiffness for evaluation of portal hypertension in compensated cirrhosis. Hepatology Communications. 2022 May;6(5):950-64.

6. INTRODUCTION Liver cirrhosis is the end stage of chronic liver disease Rupture of esophageal varices (EVs) is a common and life-threatening complication in patients with liver cirrhosis 6 Incidence of EVs bleeding is approximately 5%-15% per year The mortality rate is 15%-25% Incidence of re-bleeding rate within 6 wk after EVs rupture bleeding is 30% to 40%

7. 7 Endoscopic variceal ligation (EVL) plus nonselective b-blockers (NSBB) is the standard of care for secondary prophylaxis of esophageal variceal bleeding (EVB). Esophageal variceal bleeding (EVB) is a severe complication of portal hypertension with a mortality rate of 15% EVL plus nonselective b-blockers (NSBB) is more effective than EVL and is recommended as the first-line therapy for secondary prophylaxis of EVB Patients who survive an acute EVB should receive therapy for secondary prophylaxis of hemorrhage before they are discharged from the hospital Endoscopic variceal ligation (EVL) is the endoscopic treatment of choice for EVB INTRODUCTION

8. 8 INTRODUCTION

9. Materials and Methods 9

10. 10 Consecutive patients with cirrhosis presenting with EVB at Taipei Veterans General Hospital and Kaohsiung Veterans General Hospital were evaluated Inclusion criteria: Age range 20–80 years P atients with cirrhosis and acute or recent EVB proven by an endoscopy; and S table hemodynamic condition for at least 3 days after the first EVL Exclusion criteria: chronic kidney disease under renal replacement therapy hepatocellular carcinoma or other malignancy stroke or active sepsis a history of NSBB use, sclerotherapy, EVL, transjugular intrahepatic portosystemic shunt (TIPS), or shunt surgery serum total bilirubin .10 mg/dL grade III/IV hepatic encephalopathy refractory ascites Hepatorenal syndrome Pregnancy severe heart failure (New YorkHeart Association Fc III/IV) bronchial asthma or chronic obstructive pulmonary disease second- or third-degree atrioventricular block; sick sinus syndrome pacemaker use Severe hypotension refusal to participate MATERIALS AND METHODS MATERIALS AND METHODS

11. 11 MATERIALS AND METHODS

12. 12 MATERIALS AND METHODS

13. Randomization was performed when the hemodynamic conditions were stable, usually 3–5 days after the first EVL for acute EVB. Group A patients received EVL plus propranolol until EEV, while group B patients continued propranolol. The compliance to the study protocol was assessed by the study nurses Patients with acute EVB were resuscitated and transfused following a restrictive transfusion strategy. The patients were started on 1 g of terlipressin every 6 hours for 3 days immediately on arrival at the emergency department. Methods MATERIALS AND METHODS

14. Prophylactic antibiotics were administered for 5 days and were adjusted according to the sensitivity tests in the patients proven to have an infection, with emergency endoscopy being performed as soon as possible, usually 4–12 hours after the presentation. EVL using a pneumoactive band ligation device,an overtube (Sumitomo Bakelite, Tokyo,Japan ), and an XQ-260 or CF-290 endoscope (Olympus Optical, Tokyo, Japan) was performed in the patients with active bleeding. Otherwise, EVL was performed using a Saeed multi band ligator (Cook Medical,Bloomington , IN) or a Speedband Super view Super 7 multiple band ligator (Boston Scientific, Marlborough,MA ). Methods MATERIALS AND METHODS

15. MATERIALS AND METHODS After control of acute EVB, EVL sessions using multiple band ligators were repeated at 1-month interval until the esophageal varices (EV) were completely eradicated. The follow-up endoscopy was performed at 3-month intervals twice and then at 6 month intervals after EEV. Recurrent EV were treated with EVL until EV was eradicated again Emergency endoscopy was repeated if the patients presented upper gastrointestinal bleeding (UGIB). Recurrent EVB was managed using EVL. Terlipressin infusion with or without a balloon tamponade was allowed to arrest bleeding from ligation induced ulcers.The patients with uncontrolled variceal bleeding underwent TIPS or liver transplantation unless otherwise contraindicated. EEV and endoscopic follow-up Management of rebleeding

16. MATERIALS AND METHODS All patients started with 30 mg of propranolol daily on the 6th day after the control of the index EVB. The patients under went dose escalation every 3 days during the admission or every 7 days in the out patient clinics, aimed at decreasing the resting pulse rate by 25% but not less than 55 bpm while the systolic pressure was greater than 85 mmHg. The stable dose was maintained until EEV. Adherence to the regimen was assessed at each follow-up visit by questioning the patients or their relatives and counting the tablets whenever possible. The resting pulse rate, systolic pressure, and diastolic pressure were thrice recorded at the enrollment of the study,when the stable dose was achieved before EEV, and 3 months after EEV. The presence of gastric varices (GV) and portal hypertensive gastropathy (PHG) were evaluated at the baseline and the follow up endoscopy. Adverse events associated with both treatment strategies were monitored. The study ended 9 months after the last patient had been assigned to a group. Propranolol Use Assesment and Follow up

17. Acute EVB was defined as a presentation to the hospital within 24 hours after EVB. EV was classified according to the system proposed by Beppu et al (13). GV was classified as the system proposed by Sarin et al (14). EEV was considered to be achieved when further EVL was not feasible. Clinically significant rebleeding was defined as recurrent melena, hematemesis, or hematocheziain any of the following settings: ( i ) hospital admission; (ii) blood transfusion; (iii) 3g/dL drop in hemoglobin; or (iv) death within 6 weeks after EVL. The definition of treatment failure followed the recommendation by the Baveno VI guidelines (4). Furtherde compensation was defined as persuggestion of the Baveno VII consensus (12). Adverse events were defined as the events requiring diagnostic or therapeutic intervention during the follow-up period. Definitions MATERIALS AND METHODS

18. Written informed consent was obtained from each enrolled patient. All procedures were conducted in accordance with the ethical guidelines of the 1975 Declaration of Helsinki and the Institutional Review Boards of Kaohsiung Veterans General Hospital (VGHKS13-CT6-06) and Taipei Veterans General Hospital (2013-06-001A). Study Subject (Ethic) MATERIALS AND METHODS

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24. In this study, 2 strategies were compared with special emphasison the benefit and adverse events of propranolol use, with the results showing that most of the rebleeding occurred before EEV. EVL combined with the shorter propranolol use, i.e., discontinuing propranolol after EEV, was non inferior to EVL combined with long-term propranolol use in terms of recurrent EVB, but the patients continuing propranolol had more adverse events after EEV. 24 DISCUSSION

25. In conclusion, this trial revealed that EVL plus propranolol till EEV was non inferior to EVL plus long-term propranolol in secondary prophylaxis of EVB but was associated with fewer adverse events after EEV. These results suggested that a strategy of adding propranolol to EVL till EEV to prevent most of the rebleeding and discontinuing propranolol after EEV could be feasible for secondary prophylaxis of EVB, especially in patients who could not tolerate long term NSBB use. Further studies focusing on further decompensation and survival in patients with cirrhosis discontinuing NSBB after EEV are warranted. 25 CONCLUSSION

26. 26 CONCLUSSION

27. Thank You 27

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