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

This study has been completed.
Sponsor:
Information provided by:
National Science Council, Taiwan
ClinicalTrials.gov Identifier:
NCT01112852
First received: April 23, 2010
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Esophageal Varices
Bleeding
Drug: pantoloc 40 mg
Drug: somatostatin or terlipressin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Science Council, Taiwan:

Primary Outcome Measures:
  • Success rate of initial hemostasis [ Time Frame: 5 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: 48-120 hours after treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    The amount of blood transfusion during admission was recorded.

  • Mortality [ Time Frame: within 42 days ]
    Mortality within 42 days was recorded and compared.

  • The size and number of ulcers on varices [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    If p't agrees, a second look endoscopy is performed to detect ulcers.


Enrollment: 118
Study Start Date: December 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: pantoloc, a proton pump inhibitor

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112852

Sponsors and Collaborators
National Science Council, Taiwan
Investigators
Principal Investigator: Gin-Ho Lo E-DA Hospital
  More Information

No publications provided by National Science Council, Taiwan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chairperson, National Science Council
ClinicalTrials.gov Identifier: NCT01112852     History of Changes
Other Study ID Numbers: EVL + PPI, PPI for EVB
Study First Received: April 23, 2010
Last Updated: April 27, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Science Council, Taiwan:
control of bleed

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Proton Pump Inhibitors
Somatostatin
Terlipressin
Vasoconstrictor Agents
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014