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San Diego Bleeding Esophageal Varices Study

Primary Purpose

Survival and Control of Bleeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency portacaval shunt
Emergency and long-term endoscopic sclerotherapy
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Survival and Control of Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 200 West Arbor Drive

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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.

Emergency endoscopic sclerotherapy

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Control of bleeding and quality of life

Full Information

First Posted
June 3, 2008
Last Updated
June 3, 2008
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00690027
Brief Title
San Diego Bleeding Esophageal Varices Study
Official Title
San Diego Bleeding Esophageal Varices Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
April 1988 (undefined)
Primary Completion Date
August 1996 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Survival and Control of Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Emergency endoscopic sclerotherapy
Intervention Type
Procedure
Intervention Name(s)
Emergency portacaval shunt
Intervention Type
Procedure
Intervention Name(s)
Emergency and long-term endoscopic sclerotherapy
Primary Outcome Measure Information:
Title
Survival
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Control of bleeding and quality of life
Time Frame
10 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marshall J Orloff, M.D.
Organizational Affiliation
UCSD Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
200 West Arbor Drive
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8999
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33089892
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.
Results Reference
derived
PubMed Identifier
24402314
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. Erratum In: JAMA Surg. 2014 Jun;149(6):543.
Results Reference
derived
PubMed Identifier
22480831
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.
Results Reference
derived
PubMed Identifier
21679921
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.
Results Reference
derived
PubMed Identifier
20824373
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.
Results Reference
derived
PubMed Identifier
20658205
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.
Results Reference
derived
PubMed Identifier
19730244
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.
Results Reference
derived
PubMed Identifier
19651060
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.
Results Reference
derived

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San Diego Bleeding Esophageal Varices Study

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