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Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.

ABSTRACT:

Background

Emergency 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).

Methods

Two 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.

Results

Direct 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.

Conclusions

In 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.

SUBMITTER: Orloff MJ

PROVIDER: S-EPMC3023018 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Publications

Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.

Orloff Marshall J MJ Isenberg Jon I JI Wheeler Henry O HO Haynes Kevin S KS Jinich-Brook Horacio H Rapier Roderick R Vaida Florin F Hye Robert J RJ

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract 20100908 1

<h4>Background</h4>Emergency 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 sclerot ...[more]

PMID: 20824373

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Project description:ImportanceBleeding esophageal varices has been studied extensively, but bleeding gastric varices (BGV) has received much less investigation. However, BGV has been reported in ≤ 30% of patients with acute variceal bleeding. In our studies of 1,836 bleeding cirrhotics, 12.7% were bleeding from gastric varices. BGV mortality rate of 45-55% has been reported. The BGV literature has mainly involved retrospective case reports, often with short-term follow-up.ObjectiveWe sought to describe the results of a prospective, randomized, controlled trial (RCT) in unselected, consecutive patients with BGV comparing endoscopic therapy (ET) with portacaval shunt (PCS; n = 518), and later comparing emergency transjugular intrahepatic portosystemic shunt (TIPS) with emergency portacaval shunt (EPCS; n = 70).Design, setting, and participantsInitially, our RCT involved 518 patients with BGV comparing ET with direct PCS regarding control of bleeding, mortality rate, and disability. When entry of patients ended, the RCT was expanded to compare emergency TIPS with EPCS (n = 70). This RCT of BGV was separate from our other RCTs of bleeding esophageal varices.InterventionsInitially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS).Main outcome measuresOutcomes were survival, control of bleeding, portal-systemic encephalopathy (PSE), quality of life, and direct costs of care. In the RCT of ET versus PCS, 28 and 30%, respectively, were in Child class C. In the expanded RCT of TIPS versus EPCS, 40 and 41%, respectively, were in Child class C. Permanent control of BGV was achieved in 97-100% of patients treated by emergency or elective PCS, compared with 27-29% by ET. TIPS was even less effective, achieving long-term control of BGV in only 6%. Survival rates after PCS were greater at all time intervals and in all Child classes (P < .001). Repeated episodes of PSE occurred in 50% of TIPS patients, 16-17% treated by ET, and 8-11% treated by PCS. Shunt stenosis or occlusion occurred in 67% of TIPS patients, in contrast with 0-2% of PCS patients.ConclusionThese results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.

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.

Dataset Information

Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.

Background

Methods

Results

Conclusions

Publications

Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4.

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