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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
Sponsor:
Information provided by:
National Science Council, Taiwan

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2006
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. very early rebleeding [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. mortality, complications [ Time Frame: 42 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The etiology of portal hypertension is cirrhosis.
  2. Age ranges between 18-80 y/o.
  3. Patients presenting with acute esophageal variceal bleeding proven by emergency endoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as:

    • when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding) OR
    • when patients presented with red color signs on their esophageal varices with blood in esophagus or stomach and no other potential site of bleeding identified (inactive bleeding).
  4. EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.

Exclusion criteria:

  1. association with severe systemic illness, such as sepsis, COPD, uremia
  2. association with gastric variceal bleeding
  3. failure in the control of bleeding by emergency EVL
  4. moribund patients, died within 12 hours of enrollment
  5. Uncooperative
  6. Ever received EIS, EVL within one month prior to index bleeding
  7. Child-Pugh's scores > 10
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Responsible Party: Gin-Ho Lo, Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT00863837    
Other Study ID Numbers: NSC
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: March 18, 2009
Last Verified: March 2009
Keywords provided by National Science Council, Taiwan:
Acute variceal bleeding
banding ligation
vasoconstrictor
proton pump inhibitor
Additional relevant MeSH terms:
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Terlipressin
Vasoconstrictor Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents