Prevention of Esophageal Variceal Rebleeding

NCT ID: NCT00863837

Last Updated: 2009-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Esophageal Variceal Rebleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A

add pantoloc to reduce ulcer bleeding after banding ligation

Group Type: ACTIVE_COMPARATOR

pantoloc (proton pump inhibitor)

Intervention Type: DRUG

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

Arm B: ligation + terlipressin 1mg q6h

Arm B, intervention: ligation + terlipressin 1mg q6h

Group Type: PLACEBO_COMPARATOR

terlipressin (vasoconstrictor)

Intervention Type: DRUG

Ligation plus terlipressin 1mg q6h

Interventions

terlipressin (vasoconstrictor)

Ligation plus terlipressin 1mg q6h

Intervention Type: DRUG

pantoloc (proton pump inhibitor)

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

Intervention Type: DRUG

Other Intervention Names

vasoconstrictor; proton pump inhibitor

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kaohsiung Veterans General Hospital

Other Identifiers

NSC

Identifier Type: -

Identifier Source: org_study_id