EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding (EVL)
Primary Purpose
Esophageal Varices, Bleeding
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
pantoloc 40 mg
somatostatin or terlipressin
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Varices focused on measuring control of bleed
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
EVL + vasoconstrictor
EVL + PPI
Arm Description
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.
Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5
Outcomes
Primary Outcome Measures
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.
very early rebleeding
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
The amount of blood transfusion during admission was recorded.
Mortality
Mortality within 42 days was recorded and compared.
The size and number of ulcers on varices
If p't agrees, a second look endoscopy is performed to detect ulcers.
Full Information
NCT ID
NCT01112852
First Posted
April 23, 2010
Last Updated
April 27, 2010
Sponsor
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01112852
Brief Title
EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices, Bleeding
Keywords
control of bleed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVL + vasoconstrictor
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EVL + PPI
Arm Type
Experimental
Arm Description
Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5
Intervention Type
Drug
Intervention Name(s)
pantoloc 40 mg
Other Intervention Name(s)
pantoloc, a proton pump inhibitor
Intervention Description
pantoloc iv. infusion per day
Intervention Type
Drug
Intervention Name(s)
somatostatin or terlipressin
Other Intervention Name(s)
somatostatin and terlipressin are vasoconstrictors.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate of initial hemostasis
Description
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.
Time Frame
5 days
Title
very early rebleeding
Description
Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.
Time Frame
48-120 hours after treatment
Secondary Outcome Measure Information:
Title
The amount of blood transfusion within 42 days
Description
The amount of blood transfusion during admission was recorded.
Time Frame
42 days
Title
Mortality
Description
Mortality within 42 days was recorded and compared.
Time Frame
within 42 days
Title
The size and number of ulcers on varices
Description
If p't agrees, a second look endoscopy is performed to detect ulcers.
Time Frame
2 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gin-Ho Lo
Organizational Affiliation
E-DA Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23278466
Citation
Lo GH, Perng DS, Chang CY, Tai CM, Wang HM, Lin HC. Controlled trial of ligation plus vasoconstrictor versus proton pump inhibitor in the control of acute esophageal variceal bleeding. J Gastroenterol Hepatol. 2013 Apr;28(4):684-9. doi: 10.1111/jgh.12107.
Results Reference
derived
Learn more about this trial
EVL (Endoscopic Variceal Ligation) Plus Vasoconstrictor vs.Ligation Plus PPI( Proton Pump Inhibitor) in the Control of Acute Esophageal Variceal Bleeding
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