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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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 |
- 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.
- 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 |
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 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:
|
Esophageal Diseases Esophageal and Gastric Varices Hemorrhage Varicose Veins Gastrointestinal Diseases Digestive System Diseases Hypertension, Portal Liver Diseases Pathologic Processes Vascular Diseases Cardiovascular Diseases Somatostatin Terlipressin Vasoconstrictor Agents Lypressin |
Proton Pump Inhibitors Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Antidiuretic Agents Natriuretic Agents Hemostatics Coagulants Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013