EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding

Sponsor

National Science Council, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT01112852

Collaborator

(none)

118

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Previous studies showed that 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Varices Bleeding	Drug: pantoloc 40 mg Drug: somatostatin or terlipressin	Phase 4

Detailed Description

Thus, we 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 somatostatin infusion or losec infusion for 5 days.

AIMS:

To investigate whether the combination of EVL and somatostatin is superior to the combination of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding and very early rebleeding.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled Trial of Ligation Plus Vasoconstrictor vs.Ligation Plus Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: EVL + vasoconstrictor Somatostatin 6mg in 500 cc 5% dextrose, 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.	Drug: somatostatin or terlipressin Somatostatin 6mg in 500 cc 5% dextrose, 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. Other Names: somatostatin and terlipressin are vasoconstrictors.
Experimental: EVL + PPI Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5	Drug: pantoloc 40 mg pantoloc iv. infusion per day Other Names: pantoloc, a proton pump inhibitor

Arm

Intervention/Treatment

Active Comparator: EVL + vasoconstrictor

Somatostatin 6mg in 500 cc 5% dextrose, 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.

Drug: somatostatin or terlipressin

Other Names:

somatostatin and terlipressin are vasoconstrictors.

Experimental: EVL + PPI

Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5

Drug: pantoloc 40 mg

pantoloc iv. infusion per day

Other Names:

pantoloc, a proton pump inhibitor

Outcome Measures

Primary Outcome Measures

Success rate of initial hemostasis [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.
very early rebleeding [48-120 hours after treatment]
Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.

Secondary Outcome Measures

The amount of blood transfusion within 42 days [42 days]
The amount of blood transfusion during admission was recorded.
Mortality [within 42 days]
Mortality within 42 days was recorded and compared.
The size and number of ulcers on varices [2 weeks after treatment]
If p't agrees, a second look endoscopy is performed to detect ulcers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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: (1) when blood was directly seen by endoscopy to issue from an esophageal varix (active bleeding), or (2) 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.