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Early Feeding Following Ligation of Acute Bleeding Varices

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by E-DA Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287702
First Posted: February 1, 2011
Last Update Posted: March 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
E-DA Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by E-DA Hospital:

Primary Outcome Measures:
  • Success rate of initial hemostasis [ Time Frame: 48 hours ]
    hemostasis for 48 hours after ligation

  • very early rebleeding rate [ Time Frame: 48- 120 hours ]
    rebleeding during this period

  • ulcer bleeding rate [ Time Frame: 14 days ]
    14 days after ligation of varices


Secondary Outcome Measures:
  • The amount of blood transfuion and mortality [ Time Frame: 14 days ]
    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

  Hide Detailed Description

Detailed Description:

Acute esophageal variceal hemorrhage is a dreadful complication of portal hypertension. Its management evolved rapidly in recent years. Traditional managements include vasoconstrictor and balloon tamponade. Vasoconstrictors have been shown to control approximately 80% of bleeding episodes, are generally used as a first line therapy. Following the use of vasoconstrictor, endoscopic therapy is often employed to arrest the bleeding varices as well as preventing early rebleeding. Meta-analysis showed that the combination of vasoconstrictor and endoscopic therapy is superior to endoscopic therapy alone in the control of acute esophageal variceal hemorrhage. Our previous study showed that endoscopic variceal ligation (EVL) is superior to Endoscopic injection sclerotherapy (EIS) in the control of active variceal hemorrhage. It is thus recommended that EVL is the first enscopic treatment of choice for acute esophageal variceal bleeding. Moreover, apart from the control of acute variceal bleeding, prophylactic antibiotics has been proven to be helpful in the prevention of bacterial infection as well as preventing early variceal bleeding. With the advent of new treatment modalities and measures taken to approach patients with acute esophageal variceal bleeding, the mortality of acute esophageal variceal bleeding is significantly reduced in recent years.

On the other hand, early rebleeding due to ligation-induced ulcer may be encountered. 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, we 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.

Methods of treatment:

Enrolled 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 3)failure in the control of bleeding by emergency endoscopic treatment. 4)moribund patients, died within 12 hours of enrollment 5)Uncooperative 6) Ever received EIS, EVL within one month prior to index bleeding 7)Child-Pugh's scores > 13 8) Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites

Eligible subjects will receive vasoconstrictor for 3 days (either terlipressin or somatostatin), prophylactic antibiotics for 5 days (cephazolin or norfloxacin 400mg bid), lactulose. Eligible subjects will be randomized to 2 groups. Group 1 will be allowed to take liquid diet (fruit juice, soy bean juice, milk, rice in liquid form) for 3 days within 4 hours after endoscopic treatment. Additionally, intravenous fluid less than 500 cc per day will be given. Subsequently, soft diet will be given for 4 days, and on regular diet on the 8th day after endoscopic treatment.

Group 2 will be fasting for 48 hours after endoscopic treatment and intravenous fluids (normal saline or glucose water) 1500 cc per day with electrolytes will be administered for 2 days. After 2 days of fasting, if rebleeding does not occur, liquid diet will be given for one day, subsequently, soft diet for 4 days, and on regular diet on the 8th day after endoscopic treatment.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: IRB, E-DA hospital
ClinicalTrials.gov Identifier: NCT01287702     History of Changes
Other Study ID Numbers: early feeding after ligation
First Submitted: January 31, 2011
First Posted: February 1, 2011
Last Update Posted: March 2, 2011
Last Verified: February 2011

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