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.
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
- Recruiting
E-DA hospital
Kaohsiung City, 824
Gin Ho Lo, MD, 0975106248, ghlo@kimo.com
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:
- 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 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 group | Role | What they receive |
|---|---|---|
| Early feeding | Experimental | patients 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 feeding | Active comparator | patients 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.
Success rate of initial hemostasis
hemostasis for 48 hours after ligation
Measured: 48 hours
very early rebleeding rate
rebleeding during this period
Measured: 48- 120 hours
ulcer bleeding rate
14 days after ligation of varices
Measured: 14 days
Secondary outcomes (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.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices
- ClinicalTrials.gov ID
- NCT01287702
- Acronym / sponsor ID
- early feeding after ligation
- Conditions
- Varices
- Keywords
- early feeding, varices bleeding, to evaluate impact of early feeding on early rebleeding after ligation of varices
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early feeding | Experimental | Dietary Supplement: Early feedingpatients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL |
| Dealyed feeding | Active comparator | Dietary Supplement: Delayed feeding, Dietary Supplement: Dealyed feedingpatients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed feedingpatients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL | Dietary supplement | Dealyed feeding |
| Dealyed feedingpatients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL | Dietary supplement | Dealyed feeding |
| Early feedingpatients 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 |
Primary outcome
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
1 secondary outcome
The amount of blood transfuion and mortality
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.