Prevention of Esophageal Variceal Rebleeding

NCT00863837 | Unknown Phase 4

• 1 other identifier: NSC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Variceal Rebleeding

Keywords

Acute variceal bleeding; banding ligation; vasoconstrictor; proton pump inhibitor

Outcome Measures

Primary Outcomes (1)

• very early rebleeding

  5 days

Secondary Outcomes (1)

• mortality, complications

  42 days

Study Arms (2)

Arm A

ACTIVE COMPARATOR

add pantoloc to reduce ulcer bleeding after banding ligation

Drug: pantoloc (proton pump inhibitor)

Arm B: ligation + terlipressin 1mg q6h

PLACEBO COMPARATOR

Arm B, intervention: ligation + terlipressin 1mg q6h

Drug: terlipressin (vasoconstrictor)

Interventions

terlipressin (vasoconstrictor) DRUG

Ligation plus terlipressin 1mg q6h

Also known as: vasoconstrictor

Arm B: ligation + terlipressin 1mg q6h

pantoloc (proton pump inhibitor) DRUG

Pantoloc infusion (1 vial q.d.); Using pantoloc to reduce rebleed after EVL

Also known as: proton pump inhibitor

Arm A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The etiology of portal hypertension is cirrhosis.
• Age ranges between 18-80 y/o.
• 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).
• EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollment time: Immediately after EVL is completed and variceal bleeding is arrested.

You may not qualify if:

• association with severe systemic illness, such as sepsis, COPD, uremia
• association with gastric variceal bleeding
• failure in the control of bleeding by emergency EVL
• moribund patients, died within 12 hours of enrollment
• Uncooperative
• Ever received EIS, EVL within one month prior to index bleeding
• Child-Pugh's scores \> 10

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

MeSH Terms

Interventions

Terlipressin; Vasoconstrictor Agents; Proton Pump Inhibitors

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 16, 2009
• First Posted: March 18, 2009
• Study Start: December 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 18, 2009

Record last verified: 2009-03