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

Bleeding Clinical Trial

— EVL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112852
• Other study ID #: EVL + PPI
• Secondary ID: PPI for EVB
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2010
• Last updated: April 27, 2010
• Start date: December 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: National Science Council, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Exclusion Criteria:

• 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 > 13

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Esophageal Varices
• Hemorrhage

Intervention

Drug:
• pantoloc 40 mg
pantoloc iv. infusion per day
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Science Council, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of initial hemostasis	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.	5 days	No
Primary	very early rebleeding	Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.	48-120 hours after treatment	No
Secondary	The amount of blood transfusion within 42 days	The amount of blood transfusion during admission was recorded.	42 days	No
Secondary	Mortality	Mortality within 42 days was recorded and compared.	within 42 days
Secondary	The size and number of ulcers on varices	If p't agrees, a second look endoscopy is performed to detect ulcers.	2 weeks after treatment	No