|Year : 2016 | Volume
| Issue : 4 | Page : 169-175
Endoscopic band ligation combined with argon plasma coagulation versus band ligation alone for eradication of esophageal varices
Ali Ghweil1, Shamarden Bazeed1, Mohamed Alsenbsy2, Heba Saleh1, Mohamed El Kassas3, Bahaa Abbas4, Gamal Esmat5, Hamdy Moustafa6
1 Tropical Medicine & Gastroenterology, Faculty of Medicine, South Valley University, Qena, Egypt
2 Internal Medicine, Faculty of Medicine, South Valley University, Qena, Egypt
3 Endemic Medicine, Faculty of Medicine, Helwan University, Cairo, Egypt
4 Air Force Hospital, Cairo, Egypt
5 Endemic Medicine and Hepato-Gastroenterology, Faculty of Medicine, Cairo University, Cairo, Egypt
6 Gastroenterology & Hepatology (Tropical Medicine) Faculty of Medicine, Azhar University, Assiut, Egypt
|Date of Submission||15-Nov-2016|
|Date of Acceptance||17-Jan-2017|
|Date of Web Publication||23-Jun-2017|
Mohamed El Kassas
Faculty of Medicine, Helwan University, Helwan, Cairo
Source of Support: None, Conflict of Interest: None
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
|How to cite this article:|
Ghweil A, Bazeed S, Alsenbsy M, Saleh H, El Kassas M, Abbas B, Esmat G, Moustafa H. Endoscopic band ligation combined with argon plasma coagulation versus band ligation alone for eradication of esophageal varices. Al-Azhar Assiut Med J 2016;14:169-75
|How to cite this URL:|
Ghweil A, Bazeed S, Alsenbsy M, Saleh H, El Kassas M, Abbas B, Esmat G, Moustafa H. Endoscopic band ligation combined with argon plasma coagulation versus band ligation alone for eradication of esophageal varices. Al-Azhar Assiut Med J [serial online] 2016 [cited 2020 Dec 4];14:169-75. Available from: http://www.azmj.eg.net/text.asp?2016/14/4/169/208932
| Introduction|| |
Approximately 59% of patients with cirrhosis develop esophageal varices, and one-third of these patients experience esophageal variceal bleeding (EVB) . 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 . 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 .
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 .
A distinctive characteristic of APC produces safe and effective shallow coagulation over extensive areas .
The aim of this work was to assess safety and efficacy of endoscopic band ligation plus 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 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:
- 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.
- 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.
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.
The exclusion criteria were as follows:
- Patients for whom previous repeated sessions of sclerotherapy or rubber band ligation had been performed.
- Patients who had fundal varices.
- Patients with severe systemic disease (renal failure, heart failure, etc.).
- Patients who proved to have hepatocellular carcinoma.
- Patients with portal vein thrombosis.
- 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:
- Detailed history taking and full clinical examination.
- Laboratory investigations including:
- Complete blood picture.
- Blood urea and serum creatinine.
- Liver function tests [serum albumin, serum bilirubin, prothrombin time and concentration, and viral hepatitis markers (HBsAg and HCV Ab)].
- Child–Pugh Turcotte score.
- Abdominal ultrasonography.
- 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. .
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 .
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 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-mm-diameter 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.
The study protocol was approved by the ethical committee of our institution. All selected patients provided informed consent before enrollment in the trial.
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. 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 ([Table 4] and [Table 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.
|Table 2 Relation between grade of recurrent esophageal varices and duration of follow-up in group 2|
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|Table 3 Reported complications in group 1 group (n=50) because of argon application|
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|Table 4 Relation between complications and Child–Pugh classification in group 1|
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|Table 5 Relation between each reported complication and Child–Pugh classification in group 1|
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| Discussion|| |
In this prospective randomized study, we performed two endoscopic techniques in patients with bleeding esophageal varices to elicit the impact of the new treatment modalities on the final outcome in these patients. Comparing the results of the two groups as regards the incidence of variceal recurrence during follow-up period, we found that combined treatment group with band ligation plus APC had a significantly low recurrence rate of 1/50 (2%); this case was a male patient aged 64 years with Child–Pugh score B, showing recurrence of grade II esophageal varices with red color sign (RC++) and portal hypertensive gastropathy after 3 months of follow-up. On the other hand, the reported variceal recurrence in band ligation alone treated group was 40/50 (80%), with highly significant difference (P<0.000). This was in agreement with the results of Cipolletta et al. , who recorded no recurrence of varices or variceal hemorrhage in the APC group in a mean follow-up period of 16 months, whereas varices recurred in 42.8% (6/14) of the patients in the control group (P<0.04). Therefore, APC of the distal esophageal mucosa after eradication of esophageal varices by EVL was effective for reducing the rate of variceal recurrence. In addition, Yoshihito et al.  recorded neither recurrence of varices nor hemorrhage from esophageal varices over a maximum follow-up period of 5 months. Furthermore, Harras et al.  recorded a recurrence rate of 2/50 (4%) in combined treatment group with band ligation plus APC over a follow-up period of 24 months, but in contrast to our results they recorded a recurrence rate of 14/50(28%) in the band ligation alone treated group. This may be related to different child grading of the patients and splenectomy, which was recorded in 14/50 (28%) of patients of group 2 (band ligation group). In addition, Furukawa et al.  in the study on 11 patients found, during their follow-up for a mean±SD post-treatment period of 637.4±56.5 days, that recurrence rate after the initial obliteration by EVL and APC was 9%, so they concluded that APC is an effective prevention therapy after endoscopic variceal band ligation without serious complications. In addition, Abdel-Aal et al.  found that APC had the least recurrence rate of 1/20 (15%) as compared with other groups (P<0.001). As regards the study of Nakamura et al. , the cumulative recurrence-free rate at 24 months after treatment was significantly higher in the combined treatment group than in the ligation group (74.2 vs. 49.6%, P<0.05). Finally, they concluded that band ligation of esophageal varices combined with APC is superior to ligation alone. Furthermore, the study conducted by Mašalaitė et al.  on 133 patients who underwent endoscopic band ligation reported a recurrence rate of esophageal varices after eradication of 60/133 (45%) cases after EBL for a follow-up period more than a year, with early recurrence of esophageal varices occurring in 46.7% of cases of extrahepatic portal hypertension and a larger size of varices leading to the statistically significant early recurrence of varices after endoscopic band ligation. Finally, they concluded that endoscopic band ligation was associated with a high recurrence rate of esophageal varices, and half of these cases were identified as early variceal recurrence (within 3 months after ligation). The recurrence rate is lower than that reported in our study, which may be because of different etiologies of portal hypertension (intrahepatic and extrahepatic): 9/60 (15%) patients treated by sclerotherapy before band ligation and 10/60 (16.7%) patients with endoscopic band ligation applied as primary prophylaxis. In contrast to our study, the study by Hamza et al. , in which patients underwent surveillance endoscopy at 3 and 6 months to evaluate variceal recurrence (F1 or more), reported that both groups were comparable in terms of variceal recurrence and none of the patients in both groups developed variceal bleeding; they concluded that although APC application to the esophageal mucosa is a safe technique its additive benefit in terms of variceal recurrence and rebleeding is comparable to EVL alone. This was possibly related to the short follow-up period.
In the present study, as regards the relationship between grade of recurrent esophageal varices and duration of follow-up in group 2 (band ligation group), 17/24 (70.8%) cases presented with grade II esophageal varices within 3 months and 4/24 (16.7%) cases presented with grade II esophageal varices within 6 months, and 12/16 (75.0%) cases with grade III esophageal varices presented within 3 months and 2/16 (12.5%) of cases with grade III esophageal varices present within 6 months, with nonsignificant difference (P>0.05). In contrast to our study, Hamza et al.  reported only one case out of 30 (3.3%) that developed F2 esophageal varices (after complete variceal eradication by band ligation) after 6 months of follow-up and none of the patients exhibited variceal recurrence to large-size (F3) varices. This may be explained by the small number of cases, no data about the presence of RC sign of bleeding varices of patients at presentation, and the presence of RC sign over varices on follow-up endoscopy (the presence of RC sign increased the risk of recurrent upper gastrointestinal tract bleeding by 4.6 times compared with no RC sign); Child–Pugh class C patients constitute the least percentage of all patients.
When we examined the relation between recurrence of varices and Child–Pugh classification in group 2 , we found that 70.0% of cases without recurrence was child class A versus 40.0% withrecurrence with significance difference (P<0.05). This is in agreement with the study of Benedeto-Stojanov et al. , who recorded that patients with severe hepatocellular dysfunction (Child–Pugh group C) have the shortest period between the first bleeding and rebleeding (mean: 20.8 days) in comparison with patients with Child–Pugh group A who had a longer period free of variceal bleeding (mean: 226.7 days). In addition, Wipassakornwarawuth et al.  found that Child–Pugh’s C patients had a significantly higher rebleeding rate compared with Child–Pugh’s B and A, respectively (P=0.047). In contrast to this study, Nevens et al.  recorded no discriminative value for Child–Pugh score with regard to the risk of bleeding. In addition, Yang et al.  found that the Child–Pugh score for liver function was an independent risk factor of post-EVL rebleeding. Furthermore, Berreta et al.  proved that Child–Pugh C was an independent risk factor of death from rebleeding.
In the present study, the relation between recurrence of varices and laboratory data in G2 showed nonsignificant difference between recurrence of varices with international normalized ratio, platelets, hemoglobin, albumin, bilirubin, and creatinine (P>0.05). In agreement with this study, Ebrahimi et al.  reported that, among the biomarkers that can be used to determine the liver function status (blood bilirubin, albumin and prothrombin time or international normalized ratio), there was no significant correlation between any of the liver function biomarkers and rebleeding. This insignificant relation was found for creatinine as well. In contrast to our results, El-Sheety et al.  found a positive correlation between the presence of hyperbilirubinemia (P<0.05), hypoalbuminemia (P<0.05), prolonged prothrombin time (P<0.001), increased serum creatinine (P<0.001), and recurrent variceal rebleeding. In addition, Sharara et al.  reported that the most effective indicators of risk of early rebleeding are the factors that reflect the degree of hepatic dysfunction, including hypoalbuminemia, low prothrombin activity, and hyperbilirubinemia. This may be explained by the small number of cases in our study as we compare the 40 patients who show recurrence of varices with 10 patients who did not show recurrence. As regards thrombocytopenia, in agreement with our results, Wipassakornwarawuth et al.  concluded that platelet count was not found to be closely related to rebleeding (P=0.79). In contrast to this study, the results of the study by El-Sheety et al.  revealed that platelet count is a significant predictor or associator of recurrent variceal bleeding (P=0.001). This may be explained by the small number of cases in our study as we compare the 40 patients who show recurrence of varices with 10 patients who did not show recurrence.
As regards low hemoglobin level, in agreement with this study, Lee et al.  recorded that hemoglobin level had no significant influence on the incidence of rebleeding. However, in contrast to this study, Mostafa and Mohammad  considered that rebleeding after EVL was significantly associated with low hemoglobin level (P<0.0001). This may be explained by the observation that 34/50 (68%) patients in the group 2 had hemoglobin greater than or equal to 10 g/l. In this study, the relation between recurrence of varices and sonographic findings (splenomegaly, dilated portal vein and ascites) in group 2 (band ligation alone group) showed a nonsignificant difference between recurrence of varices and splenomegaly (P>0.05), dilated portal vein (P>0.05), and ascites (P>0.05). In agreement with these results, Goh et al.  concluded that thrombocytopenia, splenomegaly, and ascites are unreliable predictors of bleeding esophageal varices, and urgent or emergent endoscopy is still advocated to accurately diagnose bleeding esophageal varices. In contrast to this study, Umar et al.  considered that thrombocytopenia (<75 000/mm3), deranged coagulation profile (prothrombin time>1.3), spleen size (>13 cm), and portal vein diameter (>1.2 cm) are significant and reliable predictors of variceal bleeding. In addition, Xu et al. , in a large sample-size case–control study, revealed that ascites and the extent of varices were among risk factors for predicting early post-EVL rebleeding, and patients with poor liver function, especially those with large ascites and coagulation disorders, should be treated before EVL, which effectively decrease the rebleeding rate after EVL. This may be because of the small number of cases in our study as 20/40 (50%) patients who develop recurrence of varices were ascetic, whereas 3/10 (30%) who do not develop recurrence were ascetic.
In this study, the reported complications that occurred in the combined treated group were transient fever (≥38°C) in 18 patients, 18/50 (36%), who respond to antipyretic medications; retrosternal pain (5–7 days) was reported in 10 cases, 10/50 (20%); and bleeding during argon application occurred in one patient, 1/50 (2%), which was controlled by transient compression by endoscope. The development of severe complications did not occur in any of the patients. Therefore, APC was a safe and effective procedure. In agreement with our results, the study by Harras et al.  reported complications in group 4 (combined treatment group with endoscopic band ligation plus APC) as follows: transient fever (≥38°C) in 17/50 (34%) patients, transient dysphagia in 18/50 (36%) patients, ulceration in 1/50 (2%), and rebleeding in 1/50 (2%) patients. Furthermore, in the study conducted by Yoshihito et al. , no patients complained of dysphagia, retrosternal pain, bleeding necessitating endoscopic therapy, perforation, or stricture of the esophagus. On the other hand, the recorded complications in our patients were less than those recorded by Nakamura et al. , in Japan. They evaluated endoscopic induction of mucosal fibrosis by APC with band ligation for esophageal varices versus ligation alone. They found that the most common complication in patients with the combined treatment group was pyrexia (≥38°C) in 19/30 (63.3%) patients. Development of severe strictures occurred only in one (3.3%) patient, which was confirmed by resistance to passage of the endoscope, which was treated with an orally administered proton pump inhibitor. The frequency of retrosternal pain and sensation of esophageal stricture was low and not significantly different between the two groups. They concluded that APC for prevention of recurrent varices should be considered as an experimental treatment approach. In addition, the study of Cipolletta et al.  compared the use of APC after eradication of varices by band ligation versus ligation alone. During the course of the study, no serious complications were seen after APC; a transient fever occurred in 13/16 (81.25%) patients and 8/16 (50%) complained of dysphagia or retrosternal pain or discomfort. No serious complications were noted after APC.
At the same time in a study conducted by Hamza et al.  the complications reported post APC included fever in 6.7%, dysphagia in 3.3%, and stricture in 3.3%, which was treated by dilatation and procedure-related bleeding in 0%. Regarding complications of APC in the study by Abdel-Aal et al. , they found that about 70% of the cases had transient fever that was alleviated rapidly with antipyretics; this was in agreement with Cipolletta et al.  and Nakamura et al. . Dysphagia occurred in about 45% of patients, which was nearly similar to the studies by Cipolletta et al.  and Furukawa et al. ; transient retrosternal pain or heart burn developed in 60% of our patients, which was in agreement with the studies of Furukawa et al.  and Cipolletta et al. . This can be explained by fact that all these minor complications are actually ‘sequelae’ when any thermal treatment method is used in the esophagus and are therefore to some degree unavoidable. On the other hand, the slight difference between our results and those of others may be explained by our limiting the area of APC therapy to multiple small areas of coagulation: 5 cm only above gastroesophageal junction.
In the present study, there were significant differences between complication and decrease in albumin (P<0.04) and increased bilirubin (P<0.01) in the APC group. This is in agreement with the study of Harras et al. , in which hyperbilirubinemia was encountered in the combined treatment group − the mean of total bilirubin was 1.9 mg/dl − and hypoalbuminemia was also encountered in the same group − the mean albumin of the same group was 2.81 g/dl. At the same time, albumin and bilirubin are two of the parameters of Child–Pugh score and as observed from this study most complications were reported in child classes B and C. In this study, the relationship between complications and ascites in the combined treatment group showed that 62.1% of cases who developed complications have ascites and 42.9% of patients who did not develop complications were ascetic. As regards the relationship between each reported complications and ascites, the high percentage of each complication was reported in ascetic patients with nonsignificant difference (P>0.05).
In this study, mortality was reported in 10 cases, and this can be explained by that fact that 29/40 (72.5%) patients in band ligation only treated group develop early variceal recurrence within 3 months of variceal eradication and were thus excluded from the study. In the study by Harras et al. , the reported deaths were four (8%) patients in group 4 (band ligation plus APC) during 24 months of follow-up − one (2%) of them died by rebleeding and three (6%) cases died by hepatocellular failure; on the other hand, there were 6 (12%) deaths in group 2 (band ligation alone treated group) − one (2%) of them died by rebleeding and 5 (10%) cases died by hepatocellular failure. In contrast to our study, the study conducted by Cipolletta et al. , in which no patients were lost during follow-up for a mean duration of 16 months (range: 9–28 months), this may be because of exclusion of patients with advanced decompensated liver disease from the study (Child–Pugh score>11).
Last, we can conclude from this study that combined band ligation plus APC is safe and effective in prevention of variceal recurrence and rebleeding. On the other hand, the band ligation only treated patients show early recurrence of varices within 3 months, with 17/24 (70.8%) cases presenting with grade II esophageal varices and 12/16 (75.0%) cases presenting with grade III esophageal varices within 3 months.
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Conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]