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Endoscopic band ligation combined with argon plasma coagulation versus band ligation alone for eradication of esophageal varices
Ali Ghweila, Shamarden Bazeeda, Mohamed Alsenbsyb, Heba Saleha, Mohamed El Kassasc, Bahaa Abbasd, Gamal Esmate, Hamdy Moustafaf a
Tropical Medicine & Gastroenterology, Faculty of Medicine, South Valley University, Qena, Egypt, bInternal Medicine, Faculty of Medicine, South Valley University, Qena, Egypt, cEndemic Medicine, Faculty of Medicine, Helwan University, Cairo, Egypt, dAir Force Hospital, Cairo, Egypt, eEndemic Medicine and HepatoGastroenterology, Faculty of Medicine, Cairo University, Cairo, Egypt, fGastroenterology & Hepatology (Tropical Medicine) Faculty of Medicine, Azhar University, Assiut, Egypt Correspondence to Mohamed El Kassas, MD, Faculty of Medicine, Helwan University, Helwan, Cairo, Egypt, Tel: +20 111 445 5552; e-mail:
[email protected] Received 15 November 2016 Accepted 17 January 2017 Al-Azhar Assiut Medical Journal 2016, 14:169–175
Background and aim Bleeding esophageal varices are the gravest complications of liver cirrhosis, with a high mortality. Although band ligation is considered the gold standard in the eradication of varices, it is plagued by a high recurrence rate after variceal eradication. The aim of the study was to assess safety and efficacy of endoscopic band ligation plus argon plasma coagulation (APC) versus endoscopic band ligation alone for the prevention of variceal recurrence and rebleeding. Patients and methods This prospective randomized comparative study was carried out on 100 patients admitted to Tropical Medicine and Gastroenterology Department, Qena University Hospital, during the period from March 2012 to complete follow-up on March 2014. Patients were randomized into two groups: group 1 included 50 patients who were subjected to endoscopic band ligation plus APC, and group 2 included 50 patients who were subjected to variceal band ligation. Results On comparing the results of the two groups as regards the incidence of variceal recurrence during the follow-up period, combined treatment group with band ligation plus APC had a significant low recurrence rate in comparison with band ligation alone treated group. As regards post-treatment complications in the combined treated group, there was transient fever (≥38°C) in 36% of patients, retrosternal pain (5–7 days) was reported in 20% cases, and bleeding during argon application occurred in one patient 2%. The development of severe complications did not occur in any of the patients. Mortality was reported in 10 cases in group 1 (three cases died by causes not related to liver disease). Conclusion Combined band ligation plus APC is safe and effective in prevention of variceal recurrence and rebleeding. The reported side effects were mild and reported mainly in older patients with child class C. Keywords: argon, band ligation, esophageal varices Al-Azhar Assiut Med J 14:169–175 © 2017 Al-Azhar Assiut Medical Journal 1687-1693
Introduction Approximately 59% of patients with cirrhosis develop esophageal varices, and one-third of these patients experience esophageal variceal bleeding (EVB) [1]. Urgent treatment of the acute hemorrhage and steps to prevent rebleeding are essential, and thus endoscopic variceal ligation (EVL) has changed the outlook for patients with upper gastrointestinal bleeding and it is widely accepted as the optimum endoscopic treatment for EVB in the secondary prevention of EVB [2]. Because band ligation does not cause thrombosis of the feeding veins, it may help inhibit capillary proliferation and invasion by perforating veins and inducing fibrosis of the distal esophageal mucosa to prevent recurrence [3]. © 2017 Al-Azhar Assiut Medical Journal | Published by Wolters Kluwer - Medknow
Argon plasma coagulation (APC) is a noncontact thermal coagulation method in which high-frequency current is applied to the target tissue through an argon plasma jet [3]. A distinctive characteristic of APC produces safe and effective shallow coagulation over extensive areas [4]. The aim of this work was to assess safety and efficacy of endoscopic band ligation plus APC versus endoscopic This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work noncommercially, as long as the author is credited and the new creations are licensed under the identical terms. DOI: 10.4103/1687-1693.208932
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band ligation alone for the prevention of variceal recurrence and rebleeding. Patients and methods This prospective randomized comparative study was carried out on 100 patients who were admitted to Tropical Medicine and Gastroenterology Department, Qena University Hospital, during the period from March 2012 to complete follow-up on March 2014. The sample size in this study was calculated by ‘EBI’ program at power 80%, with confidence 95.0%, α 0.5 equal 100 patients divided in two groups. Patients were classified into two equal groups randomly: (1) The first group included 50 patients; they were age-matched and sex-matched and underwent band ligation every 2 weeks until they reached grade I esophageal varices, followed by APC. (2) The second group (control group) included 50 patients who underwent band ligation every 2 weeks until eradication of esophageal varices occurs. All patients were followed up for variceal recurrence and complications of APC by upper endoscopy every 3 months in the first 12 months and then every 6 months for the following 12 months. Inclusion criteria
Patients aged 15–80 years with portal hypertension due to liver cirrhosis who presented with a first episode of EVB or with history of recurrent episodes of EVB not submitted for previous intervention were included in this study. Exclusion criteria
(1) Detailed history taking and full clinical examination. (2) Laboratory investigations including: (a) Complete blood picture. (b) Blood urea and serum creatinine. (c) Liver function tests [serum albumin, serum bilirubin, prothrombin time and concentration, and viral hepatitis markers (HBsAg and HCV Ab)]. (d) Child–Pugh Turcotte score. (e) Abdominal ultrasonography. (f) Upper gastrointestinal endoscopy. All studied patients presented with postviral cirrhosis. Some patients presented with active bleeding (in the form of hematemesis and/or melena) and the others presented with a previous episode of hemorrhage from esophageal varices. Upper gastrointestinal endoscopy and EVL were carried out under conscious sedation using intravenous midazolam; the esophageal varices were graded according to Westaby et al. [5]. The risky signs noted included longitudinal red streaks on varices, cherry-red spots, and hematocystic spots (red, discrete, raised spots). EVL was performed every 2 weeks until grade I esophageal varices were seen without red color signs. Patients presenting with active bleeding were first resuscitated by conventional methods before they were subjected to emergency endoscopic diagnosis and treatment. Detection of either a large vessel without a red sign or a small vessel with a red sign was reported as recurrence [6].
The exclusion criteria were as follows: (1) Patients for whom previous repeated sessions of sclerotherapy or rubber band ligation had been performed. (2) Patients who had fundal varices. (3) Patients with severe systemic disease (renal failure, heart failure, etc.). (4) Patients who proved to have hepatocellular carcinoma. (5) Patients with portal vein thrombosis. (6) Patients who received medical treatment for portal hypertension, including nonselective β-blocker agents and nitrates. All patients of the study were subjected to the following:
Fifty patients underwent APC after reaching grade I esophageal varices by EVL (combined treatment group), and the other 50 patients were only observed by upper endoscopy for detecting variceal recurrence (control group). No other treatments were given, including the use of nonselective β-blocker agents and nitrates. The two groups were comparable for all background variables, including age, classification of esophageal varices, and Child–Pugh score. APC therapy was initiated within 2–3 weeks of reaching grade I esophageal vertices. APC was performed in one session as multiple spots 5 cm
[Downloaded free from http://www.azmj.eg.net on Thursday, June 29, 2017, IP: 197.133.56.27] Band ligation with argon for varices Ghweil et al.
above the gastroesophageal junction along 3/4 esophageal circumference. Procedures were performed with therapeutic video gastroduodenoscopes (EPK-I 5000 Olympus Europe, Hamburg, Germany), with an argon source coupled with a high-frequency generator (APC 300, ICC200; EMED, Kolonia, Poland) and flexible 1.3-mmdiameter axial probes. Mean power output applied was 45 W and gas flow rates ranged from 1.5 to 2.0 l/min. After APC, patients were treated with omeprazole (20 mg twice per day) to promote healing of the coagulated tissue. Endoscopy was performed every 3 months in both groups to check for recurrence of varices in the first 12 months and then every 6 months for the following 12 months. In case of recurrent varices, patients underwent EVL. Ethical considerations
The study protocol was approved by the ethical committee of our institution. All selected patients provided informed consent before enrollment in the trial. Statistical analysis
The data were coded and verified before data entry. Data were collected and analyzed by the computer program statistical package for the social sciences (SPSS, ver. 21; SPSS Inc., Chicago, Illinois, USA). Microsoft excel 2003 (Redmond, WA, USA) (Microsoft) was used for drawing figures Results No statistical significant difference was present between both groups regarding the sociodemographic data. In addition, this was the same for laboratory investigations including complete blood count, liver function test, and kidney function test and ultrasonographic data. Endoscopic picture of both groups was nearly the same, with no statistical differences. Recurrence of esophageal varices after intervention was higher in group 1 compared with group 2 (Table 1) despite the absence of any role to the duration of follow-up in the grade of the recurrent varices in group 2 (Table 2). In group 2 (banding only group), the child classification of the studied patients in group 1 was correlated with the occurrence of recurrence of varices, whereas the laboratory data did not correlate to this recurrence and this was also the case for laboratory data and the presence of chronic illnesses such as diabetes and hypertension.
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In group 1 (the argon group), there were reported complications such as retrosternal pain, fever, and bleeding (Table 3). The occurrence of such complications was correlated with the Child–Pugh score of the patients (Tables 4 and 5). Patients with age above 50 show significantly higher rates of complications when compared with younger patients in group 1. Low serum albumin and high bilirubin levels among all studied laboratory data were correlated with the presence of complications in the same group. Ascites were not related to the occurrence of complications. Regarding mortality in the study groups, there were seven (14.0%) deaths in group 1 with no deaths reported in group 2 (P=0.492). Deaths were calculated as seven cases, because three cases died by causes not related to liver disease (one case with Child–Pugh class A died during urological operation, one of the patients with Child–Pugh class B died in an accident, and one patient with child class C died by accidentally discovered cancer bladder); all other patients died with liver cell failure after at least 1 month of argon application. Child classification and diabetes mellitus were not correlated with the mortality in group 1, whereas elevated creatinine was associated with increased mortality in the same group. Discussion In this prospective randomized study, we performed two endoscopic techniques in patients with bleeding Table 1 Recurrence of varices in the study groups Group 1 (n=50)
Group 2 (n=50)
P-value
No recurrence
39 (78)
10 (20)
