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

NCT01112852 | Completed Phase 4 DMC

• 2 other identifiers: EVL + PPIPPI for EVB
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Varices; Bleeding

Keywords

control of bleed

Outcome Measures

Primary Outcomes (2)

• 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

• very early rebleeding

  Very early rebleeding is defined as episodes of variceal bleeding 48-120 hours after treatment.

  48-120 hours after treatment

Secondary Outcomes (3)

• The amount of blood transfusion within 42 days

  42 days

• Mortality

  within 42 days

• The size and number of ulcers on varices

  2 weeks after treatment

Study Arms (2)

EVL + vasoconstrictor

ACTIVE COMPARATOR

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

EVL + PPI

EXPERIMENTAL

Pantoloc 40 mg intravenously per day was instituted on enrollment and continued for 5

Drug: pantoloc 40 mg

Interventions

pantoloc 40 mg DRUG

pantoloc iv. infusion per day

Also known as: pantoloc, a proton pump inhibitor

EVL + PPI

somatostatin or terlipressin DRUG

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.

Also known as: somatostatin and terlipressin are vasoconstrictors.

EVL + vasoconstrictor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Science and Technology Council, Taiwan: lead

Related Publications (1)

• 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.

  PMID: 23278466 DERIVED

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hemorrhage

Interventions

Somatostatin; Terlipressin

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Oligopeptides

Study Officials

• Gin-Ho Lo

  E-DA Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 28, 2010
• Study Start: December 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 28, 2010

Record last verified: 2010-04