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VaricesPhase 4NCT01287702

Early Feeding Following Ligation of Acute Bleeding Varices

A Phase 4 study testing Delayed feeding, Dealyed feeding and Early feeding in people with Varices, run by E-DA Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Varices
What is being tested?
Delayed feeding, Dealyed feeding and Early feeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTaiwan
Study dates
Jan 2011to Oct 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • E-DA hospital

    Kaohsiung City, 824

    Gin Ho Lo, MD, 0975106248, ghlo@kimo.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Varices
Being tested
Delayed feeding, Dealyed feeding, Early feeding
Keywords
early feeding, varices bleeding, to evaluate impact of early feeding on early rebleeding after ligation of varices
Medical subject headings
Varicose Veins

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delayed feedingDietary supplement

    patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL

  • Dealyed feedingDietary supplement

    patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL

  • Early feedingDietary supplement

    patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL

Study groups in NCT01287702
Study groupRoleWhat they receive
Early feedingExperimentalpatients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
Receives: Dietary Supplement: Early feeding
Dealyed feedingActive comparatorpatients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.
Receives: Dietary Supplement: Delayed feeding; Dietary Supplement: Dealyed feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of initial hemostasis

    hemostasis for 48 hours after ligation

    Measured: 48 hours

  2. very early rebleeding rate

    rebleeding during this period

    Measured: 48- 120 hours

  3. ulcer bleeding rate

    14 days after ligation of varices

    Measured: 14 days

Secondary outcomes (1)
  1. The amount of blood transfuion and mortality

    The amount of blood transfuion and mortality with 14 days

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionJul 2013 (estimated)
  4. Study completionOct 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287702
Sponsor's protocol ID
early feeding after ligation
Status last verified
Feb 2011
First submitted
31 Jan 2011
Last updated
2 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Delayed feeding, Dealyed feeding and Early feeding in people with Varices, run by E-DA Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of initial hemostasis (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.

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