Early Feeding Following Ligation of Acute Bleeding Varices

The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices

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.

Study Overview

• Status: Unknown
• Conditions: Varices
• Intervention / Treatment: Dietary supplement: Early feeding; Dietary supplement: Delayed feeding; Dietary supplement: Dealyed feeding

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 824
    • Recruiting
    • E-DA Hospital
    • Contact: Gin Ho Lo, MD; Phone Number: 0975106248; Email: ghlo@kimo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of initial hemostasis	hemostasis for 48 hours after ligation	48 hours
very early rebleeding rate	rebleeding during this period	48- 120 hours
ulcer bleeding rate	14 days after ligation of varices	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of blood transfuion and mortality	The amount of blood transfuion and mortality with 14 days	14 days

Collaborators and Investigators

• Sponsor: E-DA Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): July 1, 2013
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (Estimate): February 1, 2011

Study Record Updates

• Last Update Posted (Estimate): March 2, 2011
• Last Update Submitted That Met QC Criteria: February 28, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: early feeding; varices bleeding; to evaluate impact of early feeding on early rebleeding after ligation of varices
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Varicose Veins
• Other Study ID Numbers: early feeding after ligation