San Diego Bleeding Esophageal Varices Study
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.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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San Diego, California, 미국, 92103-8999
- 200 West Arbor Drive
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: A
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. |
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활성 비교기: B
Emergency endoscopic sclerotherapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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활착
기간: 10 년
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10 년
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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출혈과 삶의 질 조절
기간: 10 년
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10 년
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marshall J Orloff, M.D., UCSD Medical Center
간행물 및 유용한 링크
일반 간행물
- 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.
- 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:CD000553. doi: 10.1002/14651858.CD000553.pub3.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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