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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

Early Feeding Following Ligation of Acute Bleeding Varices

Clinicaltrials.gov identifier NCT01287702

Recruitment Status Unknown status

First Posted February 1, 2011

Last update posted March 2, 2011

Study Description

Brief summary:

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 or Disease:Varices
  • Intervention/Treatment: Dietary Supplement: Delayed feeding
    Dietary Supplement: Dealyed feeding
    Dietary Supplement: Early feeding
  • Phase: Phase 4
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 120 participants
  • 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
  • Study Start Date: January 2011
  • Estimated Primary Completion Date: July 2013
  • Estimated Study Completion Date: October 2013
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Success rate of initial hemostasis [ Time Frame: 48 hours ]
    hemostasis for 48 hours after ligation
  • 2. very early rebleeding rate [ Time Frame: 48- 120 hours ]
    rebleeding during this period
  • 3. ulcer bleeding rate [ Time Frame: 14 days ]
    14 days after ligation of varices
  • Secondary Outcome Measures: 1. The amount of blood transfuion and mortality [ Time Frame: 14 days ]
    The amount of blood transfuion and mortality with 14 days
Eligibility Criteria
  • Ages Eligible for Study: 20 to 80 Years (Adult, Older Adult)
  • 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
Contacts
Locations

Taiwan
E-DA hospital
Kaohsiung

Sponsors and Collaborators

E-DA Hospital

More Information
  • Responsible Party: E-DA Hospital
  • ClinicalTrials.gov Identifier: NCT01287702 History of Changes
  • Other Study ID Numbers: early feeding after ligation
  • First Posted: February 1, 2011 Key Record Dates
  • 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: Varicose Veins Hemorrhage