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

Last updated: April 27, 2010
Sponsor: National Science Council, Taiwan
Overall Status: Completed

Phase

4

Condition

Esophageal Disorders

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT01112852
EVL + PPI
PPI for EVB
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 emergencyendoscopy within 12 hours. (Acute esophageal variceal bleeding was defined as: (1)when blood was directly seen by endoscopy to issue from an esophageal varix (activebleeding), or (2) when patients presented with red color signs on their esophagealvarices with blood in esophagus or stomach and no other potential site of bleedingidentified (inactive bleeding).

  • EVL is performed after confirmation of acute esophageal variceal bleeding. Enrollmenttime: Immediately after EVL is completed and variceal bleeding is arrested.

Exclusion

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

Total Participants: 118
Study Start date:
December 01, 2006
Estimated Completion Date:
April 30, 2010

Study 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.