Clinical trial NCT00690027: San Diego Bleeding Esophageal Varices Study
Official title: San Diego Bleeding Esophageal Varices Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survival and Control of Bleeding
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-06-04
Enrollment: 211
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* Emergency portacaval shunt, and
* Emergency and long-term endoscopic sclerotherapy.

Detailed description: See attached Synopsis - APPENDIX 1

Eligibility criteria: 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:

  * Are seen to be actively bleeding;
  * Have an adherent clot;
  * Have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, GU, DU, etc)
* Require 2 or more units of blood transfusion, will be included in the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: 10 years
Secondary outcomes:
measure: Control of bleeding and quality of life
timeFrame: 10 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 200 West Arbor Drive
state: California
Study officials:
affiliation: UCSD Medical Center
name: Marshall J Orloff, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.