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In unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of:
See attached Synopsis - APPENDIX 1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Objective: See Brief Summary, page 2. Eligibility: Patients who require > 2 units blood transfusion for bleeding esophageal varices due to cirrhosis. Randomization: By the blind card method to emergency portacaval shunt (EPCS) or emergency endoscopic sclerotherapy (EST) followed by long-term repetitive EST. Diagnostic Workup: Completed within 6hr. Rapidity of Therapy: Within 8hr. Failure of Therapy: Bleeding requiring >6u PRBC in first 7 days, or 8 units PRBC during 12 months, or rebleeding after varices were obliterated. Rescue Crossover Therapy: When primary therapy has failed. Followup: Lifelong. Data Collection on line, analysis by biostatistician Florin Vaida, PhD External Advisory, Data Monitoring and Safety Committee by 3 senior academicians. |
|
| B | Active Comparator | Emergency endoscopic sclerotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency portacaval shunt | Procedure |
| ||
| Emergency and long-term endoscopic sclerotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Control of bleeding and quality of life | 10 years |
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Inclusion Criteria:
All patients with UGI bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and BEV will be eligible for consideration (all comers).
Those who are shown to have the findings of cirrhosis and esophageal varices that:
Require 2 or more units of blood transfusion, will be included in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marshall J Orloff, M.D. | UCSD Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 200 West Arbor Drive | San Diego | California | 92103-8999 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33089892 | Derived | Simonetti RG, Perricone G, Robbins HL, Battula NR, Weickert MO, Sutton R, Khan S. Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD000553. doi: 10.1002/14651858.CD000553.pub3. | |
| 24402314 | Derived |
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| ID | Term |
|---|---|
| D004636 | Emergency Service, Hospital |
| ID | Term |
|---|---|
| D006748 | Hospital Departments |
| D006739 | Hospital Administration |
| D058016 | Health Facility Administration |
| D006268 | Health Facilities |
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| Procedure |
|
| Orloff MJ. Fifty-three years' experience with randomized clinical trials of emergency portacaval shunt for bleeding esophageal varices in Cirrhosis: 1958-2011. JAMA Surg. 2014 Feb;149(2):155-69. doi: 10.1001/jamasurg.2013.4045. |
| 22480831 | Derived | Orloff MJ, Vaida F, Isenberg JI, Wheeler HO, Haynes KS, Jinich-Brook H, Rapier R, Hye RJ, Orloff SL. Child-Turcotte score versus MELD for prognosis in a randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis. J Surg Res. 2012 Nov;178(1):139-46. doi: 10.1016/j.jss.2012.01.004. Epub 2012 Mar 10. |
| 21679921 | Derived | Orloff MJ, Isenberg JI, Wheeler HO, Haynes KS, Jinich-Brook H, Rapier R, Vaida F, Hye RJ, Orloff SL. A randomized controlled trial of emergency treatment of bleeding esophageal varices in cirrhosis for hepatocellular carcinoma. Am J Surg. 2012 Feb;203(2):182-90. doi: 10.1016/j.amjsurg.2011.02.007. Epub 2011 Jun 16. |
| 20824373 | Derived | Orloff MJ, Isenberg JI, Wheeler HO, Haynes KS, Jinich-Brook H, Rapier R, Vaida F, Hye RJ. Direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt for bleeding esophageal varices in cirrhosis--Part 4. J Gastrointest Surg. 2011 Jan;15(1):38-47. doi: 10.1007/s11605-010-1332-6. Epub 2010 Sep 8. |
| 20658205 | Derived | Orloff MJ, Isenberg JI, Wheeler HO, Haynes KS, Jinich-Brook H, Rapier R, Vaida F, Hye RJ. Emergency portacaval shunt versus rescue portacaval shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis--part 3. J Gastrointest Surg. 2010 Nov;14(11):1782-95. doi: 10.1007/s11605-010-1279-7. Epub 2010 Jul 24. |
| 19730244 | Derived | Orloff MJ, Isenberg JI, Wheeler HO, Haynes KS, Horacio JB, Rapier R, Vaida F, Hye RJ. Portal-systemic encephalopathy in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt treatment of acutely bleeding esophageal varices in cirrhosis. Ann Surg. 2009 Oct;250(4):598-610. doi: 10.1097/SLA.0b013e3181b73126. |
| 19651060 | Derived | Orloff MJ, Isenberg JI, Wheeler HO, Haynes KS, Jinich-Brook H, Rapier R, Vaida F, Hye RJ. Randomized trial of emergency endoscopic sclerotherapy versus emergency portacaval shunt for acutely bleeding esophageal varices in cirrhosis. J Am Coll Surg. 2009 Jul;209(1):25-40. doi: 10.1016/j.jamcollsurg.2009.02.059. Epub 2009 May 1. |
| D005159 | Health Care Facilities Workforce and Services |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |