Acute Gastroesophageal Variceal Bleeding Clinical Trial
— EVLFOfficial title:
Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding
NCT number | NCT03306095 |
Other study ID # | EVLF2017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2017 |
Est. completion date | July 16, 2018 |
Verified date | July 2018 |
Source | Dayanand Medical College and Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Following endoscopic therapy of variceal bleeding, the issue of when to refeed these patients
has rarely been investigated. This may imply that feeding is generally regarded as a
negligible factor in the management of bleeding varices. On the other hand, it is usually
believed that systematic fasting is required in case of patients with upper gastrointestinal
bleeding.
Some researchers in their studies demonstrated that immediate refeeding has similar outcomes
to delayed refeeding among patients with low risk of nonvariceal bleeding. The situation of
variceal bleeding is quite different from that of peptic ulcer bleeding as demonstrated by
studies of other researchers who made a review on feeding of patients with upper
gastrointestinal bleeding, and recommended that feeding should be delayed for at least 48
hours after endoscopic therapy because early refeeding may cause a shift in blood flow to the
splanchnic circulation, which in turn could lead to an increase in pressure and an increased
risk of rebleeding from the varices.
The other important reason of delay in feeding may be ascribed to the fear of occurrence of
early rebleeding induced by refeeding. In addition, repeated endoscopic examination and
therapy may be required in patients with very early rebleeding. The decision to delay feeding
is usually based on clinicians 'experience or experts' opinion rather than evidence based.
That is why we planned this study.
Status | Completed |
Enrollment | 200 |
Est. completion date | July 16, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria 1. Presence of Portal Hypertension with or without cirrhosis. 2. 18 and 80 years of age. 3. Prophylactic EVL 4. EVL was performed as maintenance treatment for Past history of bleeding varices 5. Emergency endoscopic EVL for acutely bleeding varices. Exclusion Criteria: 1. Septicemia 2. Patients with advanced hepatocellular carcinoma (HCC) 3. Failure to control variceal bleeding by emergency endoscopic therapy. 4. Uncooperative patient 5. Patient with endotracheal intubation. 6. Ever received EIS or EVL within 1 month prior to index bleeding. 7. Child Pugh's scores >13. 8. Presence of Overt hepatic encephalopathy |
Country | Name | City | State |
---|---|---|---|
India | Sandeep Singh Sidhu | Ludhiana | Punjab |
Lead Sponsor | Collaborator |
---|---|
Dayanand Medical College and Hospital |
India,
Garcia-Tsao G, Bosch J. Management of varices and variceal hemorrhage in cirrhosis. N Engl J Med. 2010 Mar 4;362(9):823-32. doi: 10.1056/NEJMra0901512. Review. Erratum in: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text. — View Citation
Hébuterne X, Vanbiervliet G. Feeding the patients with upper gastrointestinal bleeding. Curr Opin Clin Nutr Metab Care. 2011 Mar;14(2):197-201. doi: 10.1097/MCO.0b013e3283436dc5. Review. — View Citation
Laine L, Cohen H, Brodhead J, Cantor D, Garcia F, Mosquera M. Prospective evaluation of immediate versus delayed refeeding and prognostic value of endoscopy in patients with upper gastrointestinal hemorrhage. Gastroenterology. 1992 Jan;102(1):314-6. — View Citation
Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7. Review. — View Citation
Lo GH, Lin CW, Hsu YC. A controlled trial of early versus delayed feeding following ligation in the control of acute esophageal variceal bleeding. J Chin Med Assoc. 2015 Nov;78(11):642-7. doi: 10.1016/j.jcma.2015.07.004. Epub 2015 Sep 2. — View Citation
Lo GH. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci. 2010 Feb;26(2):55-67. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding | Early Re bleed Rate versus delayed variceal re bleed rate | 48 hour | |
Secondary | Mortality | Mortality rate following early and late feeding | 48 hour | |
Secondary | Hemostasis | Hemostasis | 48 hour |