Text Size

Early Feeding Following Ligation of Acute Bleeding Varices

This study is currently recruiting participants.
Verified February 2011 by E-DA Hospital
Sponsor:
Information provided by:
E-DA Hospital
ClinicalTrials.gov Identifier:
NCT01287702
First received: January 31, 2011
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
  Purpose

The impact of feeding after endoscopic treatment of gastroesophageal varices has never been investigated. It is still unknown whether early feeding may increase early rebleeding in patients with acute esophageal variceal bleeding treated with EVL. It is customary for clinicians to institute fasting for 2 or 3 days after emergency EVL. This may be a safe approach to watch against early rebleeding. However, many patients would be fasting for a longer time and nutrition may be impaired, possibly resulting in aggravation of ascites. Thus, the investigators conduct a controlled study to evaluate whether early feeding have a bad impact on patients receiving emergency EVL or histoacryl injection for bleeding gastric varices.


Condition Intervention Phase
Varices
 Dietary Supplement: Delayed feeding
Dietary Supplement: Dealyed feeding
Dietary Supplement: Early feeding
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by E-DA Hospital:

Primary Outcome Measures:
  • Success rate of initial hemostasis [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    hemostasis for 48 hours after ligation

  • very early rebleeding rate [ Time Frame: 48- 120 hours ] [ Designated as safety issue: Yes ]
    rebleeding during this period

  • ulcer bleeding rate [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    14 days after ligation of varices


Secondary Outcome Measures:
  • The amount of blood transfuion and mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    The amount of blood transfuion and mortality with 14 days


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early feeding
patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
 Dietary Supplement: Early feeding
patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
Active Comparator: Dealyed feeding
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.
 Dietary Supplement: Delayed feeding
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL
Dietary Supplement: Dealyed feeding
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The etiology of portal hypertension is cirrhosis.
  2. Age ranges between 20-80 y/o.
  3. Patients presenting with acute gastroesophageal 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). Gastric variceal bleeding is defined as active spurting from a gastric varix or presence of red spots on a gastric varix.
  4. EVL is performed after confirmation of acute esophageal variceal bleeding. Histoacryl injection is performed if acute gastric variceal bleeding is diagnosed. Bleeding is arrested on the spot.

Exclusion Criteria:

  1. association with severe systemic illness, such as sepsis, COPD, uremia, HCC, > BCLC stage B
  2. failure in the control of bleeding by emergency endoscopic treatment.
  3. moribund patients, died within 12 hours of enrollment
  4. Uncooperative
  5. Ever received EIS, EVL within one month prior to index bleeding
  6. Child-Pugh's scores > 13
  7. Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287702

Locations
Taiwan
E-DA hospital Recruiting
Kaohsiung, Taiwan, 824
Contact: Gin Ho Lo, MD     0975106248     ghlo@kimo.com    
Sponsors and Collaborators
E-DA Hospital
  More Information

No publications provided

Responsible Party: IRB, E-DA hospital
ClinicalTrials.gov Identifier: NCT01287702     History of Changes
Other Study ID Numbers: early feeding after ligation
Study First Received: January 31, 2011
Last Updated: February 28, 2011
Health Authority: IRB E-DA hospital:Taiwan

Keywords provided by E-DA Hospital:
early feeding
varices bleeding
to evaluate impact of early feeding on early rebleeding after ligation of varices

Additional relevant MeSH terms:
Hemorrhage
Varicose Veins
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013