Prevention of Esophageal Variceal Rebleeding
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|ClinicalTrials.gov Identifier: NCT00863837|
Recruitment Status : Unknown
Verified March 2009 by National Science Council, Taiwan.
Recruitment status was: Enrolling by invitation
First Posted : March 18, 2009
Last Update Posted : March 18, 2009
BACKGROUND: Previous studies showed that the combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding. The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy. Nowadays, endoscopic variceal ligation (EVL) has replaced endoscopic injection sclerotherapy (EIS) as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage. EVL alone can achieve hemotasis up to 97% even in cases of active variceal hemorrhage. However, early rebleeding due to ligation-induced ulcer may be encountered. It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL.
Thus, the investigators designed a controlled trial to compare the initial hemostasis, early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus vasoconstrictor infusion or losec infusion for 5 days.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Variceal Rebleeding||Drug: terlipressin (vasoconstrictor) Drug: pantoloc (proton pump inhibitor)||Phase 4|
Methods of treatment:
Group 1: Somatostatin 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge. Group 2: Pantoloc 20 mg intravenously per day was instituted on enrollment and continued for 5 days.
Definition of initial hemostasis:
Initial hemostasis was defined as achieving a 24h bleeding-free period within the first 48h after treatment together with stable vital signs based on Baveno consensus criteria.
Very early rebleeding was defined as: UGI bleeding occurred after initial hemostasis and within 5 days after enrollment. UGI bleeding was proven to be from esophageal varices.
Treatment failure is defined as failure to control acute bleeding episodes or very early rebleeding.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||November 2009|
|Estimated Study Completion Date :||December 2009|
Active Comparator: Arm A
add pantoloc to reduce ulcer bleeding after banding ligation
Drug: pantoloc (proton pump inhibitor)
Pantoloc infusion (1 vial q.d.); Using pantoloc to reduce rebleed after EVL
Other Name: proton pump inhibitor
Placebo Comparator: Arm B: ligation + terlipressin 1mg q6h
Arm B, intervention: ligation + terlipressin 1mg q6h
Drug: terlipressin (vasoconstrictor)
Ligation plus terlipressin 1mg q6h
Other Name: vasoconstrictor
- very early rebleeding [ Time Frame: 5 days ]
- mortality, complications [ Time Frame: 42 days ]