The Experts below are selected from a list of 786 Experts worldwide ranked by ideXlab platform
Marshall J Orloff - One of the best experts on this subject based on the ideXlab platform.
-
randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic Shunt versus Portacaval Shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis
Surgery, 2015Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Henry O Wheeler, Barbara Girard, Karen J OrloffAbstract:Importance Bleeding 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. Objective We 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 participants Initially, 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. Interventions Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS). Main outcome measures Outcomes 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 Conclusion These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
-
fifty three years experience with randomized clinical trials of emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis 1958 2011
JAMA Surgery, 2014Co-Authors: Marshall J OrloffAbstract:Importance Emergency treatment of bleeding esophageal varices (BEV) consists mainly of endoscopic and pharmacologic measures, with transjugular intrahepatic portal-systemic Shunt (TIPS) performed when bleeding is not controlled. Surgical Shunt has been relegated to salvage. At the University of California, San Diego, Medical Center, our group has conducted 10 studies of emergency Portacaval Shunt (EPCS) during 46 years. Objective To describe 2 previously reported randomized clinical trials (RCTs) conducted from 1988 to 2011 in unselected consecutive patients who received emergency treatment for BEV. Design, Setting, and Participants In RCT No. 1, a total of 211 unselected consecutive patients with cirrhosis and acute BEV were randomized to emergency endoscopic sclerotherapy (EEST) (n = 106) or EPCS (n = 105). In RCT No. 2, a total of 154 unselected consecutive patients with cirrhosis and acute BEV were randomized to TIPS (n = 78) or EPCS (n = 76). Diagnostic workup was completed within 6 hours of initial contact, and primary treatment was initiated within 8 to 12 hours. Regular follow-up for up to 10 years was accomplished in 100% of the patients. Interventions In RCT No. 1, EEST or EPCS; in RCT No. 2, TIPS or EPCS. Main Outcomes and Measures The 2 groups were compared with regard to survival, control of bleeding, portal-systemic encephalopathy, and direct cost of care. Results Distribution in Child risk classes was almost identical. One-third of patients were in Child class C. Permanent control of bleeding was achieved by EEST in only 20% of the patients and by TIPS in only 22%. In contrast, EPCS permanently controlled bleeding in 97% and 100% of the patients in RCT No. 2 and RCT No. 1, respectively ( P P P Conclusions and Relevance Emergency Portacaval Shunt permanently stopped variceal bleeding, almost never became occluded, accomplished 5 times the long-term survival than EEST or TIPS, and was much less costly than EEST or TIPS. The widespread practice of using EPCS mainly as salvage for failure of endoscopic therapy or TIPS is not supported by the definitive results of these long-term RCTs in unselected patients with cirrhosis. Trial Registration clinicaltrials.gov Identifier:NCT00690027andNCT00734227
-
randomized controlled trial of emergency transjugular intrahepatic portosystemic Shunt versus emergency Portacaval Shunt treatment of acute bleeding esophageal varices in cirrhosis
Journal of Gastrointestinal Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio JinichbrookAbstract:Background Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic Shunt (TIPS) when bleeding is not controlled. Surgical portosystemic Shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic Shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency Portacaval Shunt (EPCS) in patients with cirrhosis and acute BEV.
-
disability index in a randomized controlled trial of emergency sclerotherapy versus Portacaval Shunt for bleeding varices in cirrhosis
American Journal of Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Susan L OrloffAbstract:Abstract Background Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency Portacaval Shunt (EPCS). Methods There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. Results Ten-year survival was 8% after EST versus 51% after EPCS (P Conclusions EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.
-
direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis part 4
Journal of Gastrointestinal Surgery, 2011Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract: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).
Robert J Hye - One of the best experts on this subject based on the ideXlab platform.
-
randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic Shunt versus Portacaval Shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis
Surgery, 2015Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Henry O Wheeler, Barbara Girard, Karen J OrloffAbstract:Importance Bleeding 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. Objective We 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 participants Initially, 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. Interventions Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS). Main outcome measures Outcomes 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 Conclusion These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
-
randomized controlled trial of emergency transjugular intrahepatic portosystemic Shunt versus emergency Portacaval Shunt treatment of acute bleeding esophageal varices in cirrhosis
Journal of Gastrointestinal Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio JinichbrookAbstract:Background Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic Shunt (TIPS) when bleeding is not controlled. Surgical portosystemic Shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic Shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency Portacaval Shunt (EPCS) in patients with cirrhosis and acute BEV.
-
disability index in a randomized controlled trial of emergency sclerotherapy versus Portacaval Shunt for bleeding varices in cirrhosis
American Journal of Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Susan L OrloffAbstract:Abstract Background Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency Portacaval Shunt (EPCS). Methods There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. Results Ten-year survival was 8% after EST versus 51% after EPCS (P Conclusions EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.
-
direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis part 4
Journal of Gastrointestinal Surgery, 2011Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract: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).
-
emergency Portacaval Shunt versus rescue Portacaval Shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis part 3
Journal of Gastrointestinal Surgery, 2010Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract:Background Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency Portacaval Shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, Portacaval Shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed. Question: Is the regimen of endoscopic sclerotherapy with rescue Portacaval Shunt for failure to control bleeding varices superior to emergency Portacaval Shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt conducted from 1988 to 2005.
Kevin S Haynes - One of the best experts on this subject based on the ideXlab platform.
-
randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic Shunt versus Portacaval Shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis
Surgery, 2015Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Henry O Wheeler, Barbara Girard, Karen J OrloffAbstract:Importance Bleeding 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. Objective We 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 participants Initially, 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. Interventions Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS). Main outcome measures Outcomes 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 Conclusion These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
-
randomized controlled trial of emergency transjugular intrahepatic portosystemic Shunt versus emergency Portacaval Shunt treatment of acute bleeding esophageal varices in cirrhosis
Journal of Gastrointestinal Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio JinichbrookAbstract:Background Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic Shunt (TIPS) when bleeding is not controlled. Surgical portosystemic Shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic Shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency Portacaval Shunt (EPCS) in patients with cirrhosis and acute BEV.
-
disability index in a randomized controlled trial of emergency sclerotherapy versus Portacaval Shunt for bleeding varices in cirrhosis
American Journal of Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Susan L OrloffAbstract:Abstract Background Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency Portacaval Shunt (EPCS). Methods There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. Results Ten-year survival was 8% after EST versus 51% after EPCS (P Conclusions EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.
-
direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis part 4
Journal of Gastrointestinal Surgery, 2011Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract: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).
-
emergency Portacaval Shunt versus rescue Portacaval Shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis part 3
Journal of Gastrointestinal Surgery, 2010Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract:Background Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency Portacaval Shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, Portacaval Shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed. Question: Is the regimen of endoscopic sclerotherapy with rescue Portacaval Shunt for failure to control bleeding varices superior to emergency Portacaval Shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt conducted from 1988 to 2005.
Horacio Jinichbrook - One of the best experts on this subject based on the ideXlab platform.
-
randomized controlled trial of emergency transjugular intrahepatic portosystemic Shunt versus emergency Portacaval Shunt treatment of acute bleeding esophageal varices in cirrhosis
Journal of Gastrointestinal Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio JinichbrookAbstract:Background Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic Shunt (TIPS) when bleeding is not controlled. Surgical portosystemic Shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic Shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency Portacaval Shunt (EPCS) in patients with cirrhosis and acute BEV.
-
disability index in a randomized controlled trial of emergency sclerotherapy versus Portacaval Shunt for bleeding varices in cirrhosis
American Journal of Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Susan L OrloffAbstract:Abstract Background Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency Portacaval Shunt (EPCS). Methods There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. Results Ten-year survival was 8% after EST versus 51% after EPCS (P Conclusions EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.
-
direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis part 4
Journal of Gastrointestinal Surgery, 2011Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract: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).
-
emergency Portacaval Shunt versus rescue Portacaval Shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis part 3
Journal of Gastrointestinal Surgery, 2010Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract:Background Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency Portacaval Shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, Portacaval Shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed. Question: Is the regimen of endoscopic sclerotherapy with rescue Portacaval Shunt for failure to control bleeding varices superior to emergency Portacaval Shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt conducted from 1988 to 2005.
-
portal systemic encephalopathy in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt treatment of acutely bleeding esophageal varices in cirrhosis
Annals of Surgery, 2009Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract:Background: In patients with cirrhosis and bleeding esophageal varices, there is a widespread belief that control of bleeding by portal-systemic Shunts is compromised by a high incidence of Shunt-related portal-systemic encephalopathy (PSE). This important issue was examined by a randomized controlled trial that compared emergency and long-term endoscopic sclerotherapy (EST) to emergency direct Portacaval Shunt (EPCS) in patients with cirrhosis and acute variceal hemorrhage. Methods: The study was a community-wide undertaking known as the San Diego Bleeding Esophageal Varices Study. A total of 211 unselected, consecutive patients with biopsy-proven cirrhosis and endoscopically proven, acutely bleeding esophageal varices that required at least 2 units of blood transfusion were randomized to EST (n = 106) or EPCS (n = 105). The diagnostic workup was completed in less than 6 hours and EST or EPCS was initiated within 8 hours of initial contact. Long-term EST was performed according to a deliberate schedule over months. Criteria for failure of EST or EPCS were clearly defined and crossover rescue treatment was applied, whenever possible, when failure of primary therapy was declared. PSE was quantitated by a "blinded" senior faculty gastroenterologist. Four variously weighted components of PSE were graded on a scale of 0 to 4: (1) mental state, (2) asterixis, (3) number connection test, and (4) arterial blood ammonia. PSE was classified as recurrent if 2 or more episodes were documented. All patients (100%) had follow-up for more than 9.4 years or until death. Results: Child's risk classes in the EST and EPCS groups, respectively, were 25% and 30% in class A, 43% and 47% in class B, and 26% and 29% in class C. Mean time from onset of bleeding to EST or EPCS was less than 24 hours, and from study entry to EST or EPCS was 3.1 to 4.4 hours, respectively. EST achieved permanent control of bleeding in only 20% of patients, while EPCS permanently controlled bleeding in every patient (P ≤ 0.001). Survival following EPCS was 3.5 to 5 times greater than that of EST at 5, 10, and 15 years (P ≤ 0.001). The incidence of recurrent PSE following EST (35%) was more than twice the incidence following EPCS (15%) (P ≤ 0.001). EST patients had a total of 179 episodes of PSE and 146 PSE-related hospital admissions, compared with EPCS patients who had 94 episodes of PSE and 87 hospital admissions (P ≤ 0.001). Recurrent upper gastrointestinal bleeding, which was rare in the EPCS group, was a major causative factor of PSE in the EST patients. Conclusions: In contrast to EST, EPCS permanently controlled variceal bleeding, resulted in significantly greater long-term survival, and was followed by a relatively low (15%) incidence of PSE. These results were facilitated by rigorous, frequent, and lifelong follow-up that included regular counseling on dietary protein restriction and abstinence from alcohol, and by long-term patency of the Portacaval Shunt in 98% of patients. Furthermore, these results call into question the practice of avoiding Portacaval Shunt because of fear of PSE, and thereby foregoing the lifesaving advantage achieved by surgical control of bleeding. (clinicaltrials.gov NCT00690027).
Florin Vaida - One of the best experts on this subject based on the ideXlab platform.
-
randomized trials of endoscopic therapy and transjugular intrahepatic portosystemic Shunt versus Portacaval Shunt for emergency and elective treatment of bleeding gastric varices in cirrhosis
Surgery, 2015Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Henry O Wheeler, Barbara Girard, Karen J OrloffAbstract:Importance Bleeding 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. Objective We 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 participants Initially, 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. Interventions Initially, ET was compared with PCS. In the second part of our RCT, emergency TIPS was compared with emergency PCS (EPCS). Main outcome measures Outcomes 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 Conclusion These results support the conclusion that PCS is uniformly effective, whereas ET and TIPS are not very effective.
-
randomized controlled trial of emergency transjugular intrahepatic portosystemic Shunt versus emergency Portacaval Shunt treatment of acute bleeding esophageal varices in cirrhosis
Journal of Gastrointestinal Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio JinichbrookAbstract:Background Emergency treatment of bleeding esophageal varices (BEV) in cirrhosis is of paramount importance because of the resultant high mortality rate. Emergency therapy today consists mainly of endoscopic and pharmacologic measures, with use of transjugular intrahepatic portosystemic Shunt (TIPS) when bleeding is not controlled. Surgical portosystemic Shunt has been relegated to last resort salvage when all other measures fail. Regrettably, no randomized controlled trials have been reported in which TIPS and surgical portosystemic Shunt were compared in unselected patients with acute BEV, with long-term follow-up. This is a report of a long-term prospective randomized controlled trial (RCT) that compared TIPS with emergency Portacaval Shunt (EPCS) in patients with cirrhosis and acute BEV.
-
disability index in a randomized controlled trial of emergency sclerotherapy versus Portacaval Shunt for bleeding varices in cirrhosis
American Journal of Surgery, 2012Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Robert J Hye, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Susan L OrloffAbstract:Abstract Background Disability has not been studied after emergency treatment of bleeding esophageal varices (BEV). We created a disability index (DI) in a randomized controlled trial comparing emergency endoscopic therapy (EST) versus emergency Portacaval Shunt (EPCS). Methods There were 211 unselected, consecutive patients with cirrhosis and acute BEV who were randomized to EST (n = 106) or EPCS (n = 105). Diagnostic work-up and treatment were performed within 8 hours. Ninety-six percent underwent more than 10 years follow-up evaluation. Disability was measured by assessing 9 factors to create a DI. Results Ten-year survival was 8% after EST versus 51% after EPCS (P Conclusions EPCS resulted in a markedly better DI than EST, a significantly higher survival rate, better control of bleeding, and a lower incidence of PSE. EPCS is an effective first-line emergency treatment of BEV.
-
direct costs of care in a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt for bleeding esophageal varices in cirrhosis part 4
Journal of Gastrointestinal Surgery, 2011Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract: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).
-
emergency Portacaval Shunt versus rescue Portacaval Shunt in a randomized controlled trial of emergency treatment of acutely bleeding esophageal varices in cirrhosis part 3
Journal of Gastrointestinal Surgery, 2010Co-Authors: Marshall J Orloff, Florin Vaida, Kevin S Haynes, Jon I Isenberg, Horacio Jinichbrook, Henry O Wheeler, Roderick Rapier, Robert J HyeAbstract:Background Emergency treatment of bleeding esophageal varices in cirrhosis is of singular importance because of the high mortality rate. Emergency Portacaval Shunt is rarely used today because of the belief, unsubstantiated by long-term randomized trials, that it causes frequent portal-systemic encephalopathy and liver failure. Consequently, Portacaval Shunt has been relegated solely to salvage therapy when endoscopic and pharmacologic therapies have failed. Question: Is the regimen of endoscopic sclerotherapy with rescue Portacaval Shunt for failure to control bleeding varices superior to emergency Portacaval Shunt? A unique opportunity to answer this question was provided by a randomized controlled trial of endoscopic sclerotherapy versus emergency Portacaval Shunt conducted from 1988 to 2005.