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Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

ABSTRACT: BACKGROUND:The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients. METHODS:This prospective study included 113 cirrhotic patients with actively bleeding esophageal varices. They were randomly treated by endoscopic sclerotherapy or cyanoacrylate injection as banding was not suitable for those patients due to profuse bleeding making unclear endoscopic visual field. Primary outcome was incidence of active bleeding control and secondary outcomes were incidence of six weeks rebleeding, complications, and mortality among the studied patients. RESULTS:Initial bleeding control was significantly higher in cyanoacrylate versus sclerotherapy groups (98.25, 83.93% respectively, P?=?0.007). No significant differences between sclerotherapy and cyanoacrylate groups regarding rebleeding (26.79, 19.30% respectively, P?=?0.344), complications, hospital stay or mortality rate were observed. CONCLUSIONS:Based on this single-center prospective study, both of these therapies appear to have relatively favorable outcomes, although cyanoacrylate injection may be superior to sclerotherapy for initial control of active bleeding. TRIAL REGISTRATION:[ClinicalTrials.gov Identifier: NCT03388125 ]-Date of registration: January 2, 2018 "Retrospectively registered".

SUBMITTER: Elsebaey MA

PROVIDER: S-EPMC6362581 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

Elsebaey Mohamed A MA Tawfik Mohamed A MA Ezzat Sherif S Selim Amal A Elashry Heba H Abd-Elsalam Sherief S

BMC gastroenterology 20190204 1

<h4>Background</h4>The management of acute esophageal variceal bleeding remains a clinical challenge. Band ligation is the main therapeutic option, but it may be technically difficult to perform in active bleeders. This may necessitate an alternative therapy for this group of patients. This study was conducted to assess the safety and efficacy of sclerotherapy versus cyanoacrylate injection for management of actively bleeding esophageal varices in cirrhotic patients.<h4>Methods</h4>This prospect ...[more]

PMID: 30717684

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Project description:Video 1Balloon-compression endoscopic injection sclerotherapy for the treatment of esophageal varices. A 50-year-old man with schistosomiasis-induced liver fibrosis presented with melena and hematemesis. The bleeding stopped after intravenous administration of somatostatin and ceftriaxone for 4 days. Balloon-compression endoscopic injection sclerotherapy (bc-EIS) was performed with the patient under general anesthesia to prevent rebleeding. The novel device for bc-EIS is composed of a syringe, a stopcock, a catheter, and an inflatable balloon. In the majority of patients with cirrhosis, the blood flow from the coronary vein drains into the azygos and hemiazygos venous system through esophageal and para-esophageal varices, and eventually back to the inferior vena cava. With compression of proximal esophageal and para-esophageal varices via an inflated balloon, sclerosant can be retained at the injection site, rather than flowing back to the inferior vena cava. Endoscopy revealed the presence of moderately enlarged, beady esophageal varices with red wale signs in the middle and lower esophagus. An inflatable balloon was fixed to an endoscope at a distance of 3 cm from its distal end. When the end of the endoscope was introduced to the target varices, 20 mL of air was injected into the balloon through a thin catheter, making its outer diameter expand to 3.5 cm. A disposable endoscopic injection needle then entered the base of the variceal columns near the cardia. When blood flowed back into the needle, a mixture of Lauromacrogol and methylene blue was intravariceally administered. Minor bleeding at the injection site was stopped through brief compression with the needle sheath. The second injection was performed following the aforementioned procedure. Follow-up endoscopy at 1 month, 4 months, and 7 months revealed the progression from thrombosed blue varices to complete eradication of esophageal varices. Endoscopic ultrasonography also showed the absence of blood flow in the varices after treatment. To date, bc-EIS has been performed successfully on 28 patients with esophageal varices. Variceal eradication was obtained in 17 patients with 1 session, 10 patients with 2 sessions, and 1 patient with 3 sessions. Two patients showed recurrence of esophageal varices on routine follow-up endoscopy and were re-treated with bc-EIS successfully. There were no severe complications during the follow-up period. With the sclerosant retained at injection sites after balloon compression, bc-EIS enables complete eradication of esophageal varices and lowers the risk of recurrence. The blockade of sclerosant also decreases the incidence of complications related to large-volume injection of sclerosant, such as embolization, ulceration, and perforation. In conclusion, bc-EIS appears to be an effective and safe approach for the treatment of esophaeal varices. Further research is underway to determine its suitability for large-scale clinical application.

Project description:BackgroundEmergency treatment of bleeding esophageal varices (BEV) in cirrhotic patients is of prime importance because of the high mortality rate surrounding the episode of acute bleeding. Nevertheless, there is a paucity of randomized controlled trials of emergency surgical therapy and no reports of the costs of any of the widely used forms of emergency treatment. The important issue of direct costs of care was examined in a randomized controlled trial that compared endoscopic sclerotherapy (EST) to emergency portacaval shunt (EPCS).MethodsTwo hundred eleven unselected consecutive patients with ultimately biopsy-proven cirrhosis and endoscopically proven acute BEV were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic workup was completed, and EST or EPCS was initiated within 8 h. Criteria for failure of EST or EPCS were clearly defined, and crossover rescue treatment was applied, when primary therapy failed. Ninety-six percent of patients underwent more than 10 years follow-up, or until death. Complete charges for all aspects of care were obtained continuously for more than 10 years.ResultsDirect charges for all aspects of care were significantly lower in patients treated by EPCS than in patients treated by emergency EST followed by long-term repetitive sclerotherapy. Charges per patient, per year of treatment, and per year in each child's risk class were significantly lower in patients randomized to EPCS. Charges in patients who failed endoscopic sclerotherapy and underwent a rescue portacaval shunt were significantly higher than the charges in both the unshunted sclerotherapy patients and the patients randomized to EPCS. This result was particularly noteworthy given the widespread practice of using surgical portacaval shunt as rescue treatment only when all other forms of therapy have failed.ConclusionsIn this randomized controlled trial of emergency treatment of acute BEV, EPCS was significantly superior to EST with regard to direct costs of care as reflected in charges for care as well as in survival rate, control of bleeding, and incidence of portal-systemic encephalopathy. These results provide support for the use of EPCS as a first line of emergency treatment of BEV in cirrhosis.

Dataset Information

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

Publications

Endoscopic injection sclerotherapy versus N-Butyl-2 Cyanoacrylate injection in the management of actively bleeding esophageal varices: a randomized controlled trial.

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