Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT01287702
Status:
UNKNOWN
Last Update Posted:
2011-03-02
First Post:
2011-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Feeding Following Ligation of Acute Bleeding Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-28', 'studyFirstSubmitDate': '2011-01-31', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of initial hemostasis', 'timeFrame': '48 hours', 'description': 'hemostasis for 48 hours after ligation'}, {'measure': 'very early rebleeding rate', 'timeFrame': '48- 120 hours', 'description': 'rebleeding during this period'}, {'measure': 'ulcer bleeding rate', 'timeFrame': '14 days', 'description': '14 days after ligation of varices'}], 'secondaryOutcomes': [{'measure': 'The amount of blood transfuion and mortality', 'timeFrame': '14 days', 'description': 'The amount of blood transfuion and mortality with 14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['early feeding', 'varices bleeding', 'to evaluate impact of early feeding on early rebleeding after ligation of varices'], 'conditions': ['Varices']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nOn 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.\n\nMethods of treatment:\n\nEnrolled Criteria:\n\n1. The etiology of portal hypertension is cirrhosis.\n2. Age ranges between 20-80 y/o.\n3. 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.\n4. 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.\n\nExclusion criteria:\n\n1\\) 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\n\nEligible 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.\n\nGroup 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The etiology of portal hypertension is cirrhosis.\n2. Age ranges between 20-80 y/o.\n3. 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.\n4. 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.\n\nExclusion Criteria:\n\n1. association with severe systemic illness, such as sepsis, COPD, uremia, HCC, \\> BCLC stage B\n2. failure in the control of bleeding by emergency endoscopic treatment.\n3. moribund patients, died within 12 hours of enrollment\n4. Uncooperative\n5. Ever received EIS, EVL within one month prior to index bleeding\n6. Child-Pugh's scores \\> 13\n7. Deep jaundice (serum bilirubin \\> 10 mg/dl), presence of encephalopathy \\> stage II or massive ascites"}, 'identificationModule': {'nctId': 'NCT01287702', 'briefTitle': 'Early Feeding Following Ligation of Acute Bleeding Varices', 'organization': {'class': 'OTHER', 'fullName': 'E-DA Hospital'}, 'officialTitle': 'The Impact of Early Feeding Following Ligation of the Acute Bleeding Varices', 'orgStudyIdInfo': {'id': 'early feeding after ligation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early feeding', 'description': 'patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL', 'interventionNames': ['Dietary Supplement: Early feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dealyed feeding', 'description': 'patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL.', 'interventionNames': ['Dietary Supplement: Delayed feeding', 'Dietary Supplement: Dealyed feeding']}], 'interventions': [{'name': 'Delayed feeding', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL', 'armGroupLabels': ['Dealyed feeding']}, {'name': 'Dealyed feeding', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL', 'armGroupLabels': ['Dealyed feeding']}, {'name': 'Early feeding', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL', 'armGroupLabels': ['Early feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '824', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Gin Ho Lo, MD', 'role': 'CONTACT', 'email': 'ghlo@kimo.com', 'phone': '0975106248'}], 'facility': 'E-DA hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'E-DA Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'IRB', 'oldOrganization': 'E-DA hospital'}}}}