Early Feeding Following Ligation of Acute Bleeding Varices
Primary Purpose
Varices
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Delayed feeding
Dealyed feeding
Early feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Varices focused on measuring early feeding, varices bleeding, to evaluate impact of early feeding on early rebleeding after ligation of varices
Eligibility Criteria
Inclusion Criteria:
- The etiology of portal hypertension is cirrhosis.
- Age ranges between 20-80 y/o.
- 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.
- 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:
- association with severe systemic illness, such as sepsis, COPD, uremia, HCC, > BCLC stage B
- failure in the control of bleeding by emergency endoscopic treatment.
- 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
- Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites
Sites / Locations
- E-DA hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early feeding
Dealyed feeding
Arm Description
patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.
Outcomes
Primary Outcome Measures
Success rate of initial hemostasis
hemostasis for 48 hours after ligation
very early rebleeding rate
rebleeding during this period
ulcer bleeding rate
14 days after ligation of varices
Secondary Outcome Measures
The amount of blood transfuion and mortality
The amount of blood transfuion and mortality with 14 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01287702
Brief Title
Early Feeding Following Ligation of Acute Bleeding Varices
Official Title
The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
E-DA Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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:
The etiology of portal hypertension is cirrhosis.
Age ranges between 20-80 y/o.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varices
Keywords
early feeding, varices bleeding, to evaluate impact of early feeding on early rebleeding after ligation of varices
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early feeding
Arm Type
Experimental
Arm Description
patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
Arm Title
Dealyed feeding
Arm Type
Active Comparator
Arm Description
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.
Intervention Type
Dietary Supplement
Intervention Name(s)
Delayed feeding
Intervention Description
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL
Intervention Type
Dietary Supplement
Intervention Name(s)
Dealyed feeding
Intervention Description
patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL
Intervention Type
Dietary Supplement
Intervention Name(s)
Early feeding
Intervention Description
patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
Primary Outcome Measure Information:
Title
Success rate of initial hemostasis
Description
hemostasis for 48 hours after ligation
Time Frame
48 hours
Title
very early rebleeding rate
Description
rebleeding during this period
Time Frame
48- 120 hours
Title
ulcer bleeding rate
Description
14 days after ligation of varices
Time Frame
14 days
Secondary Outcome Measure Information:
Title
The amount of blood transfuion and mortality
Description
The amount of blood transfuion and mortality with 14 days
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The etiology of portal hypertension is cirrhosis.
Age ranges between 20-80 y/o.
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.
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:
association with severe systemic illness, such as sepsis, COPD, uremia, HCC, > BCLC stage B
failure in the control of bleeding by emergency endoscopic treatment.
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
Deep jaundice (serum bilirubin > 10 mg/dl), presence of encephalopathy > stage II or massive ascites
Facility Information:
Facility Name
E-DA hospital
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gin Ho Lo, MD
Phone
0975106248
Email
ghlo@kimo.com
12. IPD Sharing Statement
Learn more about this trial
Early Feeding Following Ligation of Acute Bleeding Varices
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