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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.AnnS

Abstract

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).

Authors+Show Affiliations

Department of Surgery, University of California, San Diego Medical Center, San Diego, CA 92103–8999, USA. morloff@ucsd.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19730244

Citation

Orloff, Marshall J., et al. "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, vol. 250, no. 4, 2009, pp. 598-610.
Orloff MJ, Isenberg JI, Wheeler HO, et al. 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;250(4):598-610.
Orloff, M. J., Isenberg, J. I., Wheeler, H. O., Haynes, K. S., Horacio, J. B., Rapier, R., Vaida, F., & Hye, R. J. (2009). 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, 250(4), 598-610. https://doi.org/10.1097/SLA.0b013e3181b73126
Orloff MJ, et al. 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;250(4):598-610. PubMed PMID: 19730244.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Portal-systemic encephalopathy in a randomized controlled trial of endoscopic sclerotherapy versus emergency portacaval shunt treatment of acutely bleeding esophageal varices in cirrhosis. AU - Orloff,Marshall J, AU - Isenberg,Jon I, AU - Wheeler,Henry O, AU - Haynes,Kevin S, AU - Horacio,Jinich-Brook, AU - Rapier,Roderick, AU - Vaida,Florin, AU - Hye,Robert J, PY - 2009/9/5/entrez PY - 2009/9/5/pubmed PY - 2011/6/3/medline SP - 598 EP - 610 JF - Annals of surgery JO - Ann Surg VL - 250 IS - 4 N2 - 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). SN - 1528-1140 UR - https://www.unboundmedicine.com/medline/citation/19730244/Portal_systemic_encephalopathy_in_a_randomized_controlled_trial_of_endoscopic_sclerotherapy_versus_emergency_portacaval_shunt_treatment_of_acutely_bleeding_esophageal_varices_in_cirrhosis_ L2 - https://doi.org/10.1097/SLA.0b013e3181b73126 DB - PRIME DP - Unbound Medicine ER -