Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding

NCT03306095 | Completed DMC

• 1 other identifier: EVLF2017
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Gastroesophageal Variceal Bleeding

Outcome Measures

Primary Outcomes (1)

• Bleeding

  Early Re bleed Rate versus delayed variceal re bleed rate

  48 hour

Secondary Outcomes (2)

• Mortality

  48 hour

• Hemostasis

  48 hour

Study Arms (2)

Early refeeding group

Food Intake by patient with in 4 hours i.e \<4 hours after the EVL procedure

Other: Early refeeding group; Other: Delayed refeeding group

Delayed refeeding group

Food Intake by patient with in 4 hours i.e \> 4 hours after the EVL procedure

Other: Early refeeding group; Other: Delayed refeeding group

Interventions

Early refeeding group OTHER

Food Intake by patient with in 4 hours i.e \<4 hours after the EVL procedure

Delayed refeeding group; Early refeeding group

Delayed refeeding group OTHER

Food Intake by patient after 4 hours i.e \> 4 hours after the EVL procedure

Delayed refeeding group; Early refeeding group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Based on earlier study done by Gin-Ho Lo et al where the prevalence of UGI bleed in early refeeding group was 33 % and late refeeding group was 10 % a sample size required to detect any significant difference was found to be 88. Adding to which 10 % of attrition a total sample size of 100 was taken.

You may qualify if:

• Presence of Portal Hypertension with or without cirrhosis.
• and 80 years of age.
• Prophylactic EVL
• EVL was performed as maintenance treatment for Past history of bleeding varices
• Emergency endoscopic EVL for acutely bleeding varices.

You may not qualify if:

• Septicemia
• Patients with advanced hepatocellular carcinoma (HCC)
• Failure to control variceal bleeding by emergency endoscopic therapy.
• Uncooperative patient
• Patient with endotracheal intubation.
• Ever received EIS or EVL within 1 month prior to index bleeding.
• Child Pugh's scores \>13.
• Presence of Overt hepatic encephalopathy

Sponsors & Collaborators

• Dayanand Medical College and Hospital: lead

Study Sites (1)

Sandeep Singh Sidhu

Ludhiana, Punjab, 141001, India

Location

Related Publications (6)

• Hebuterne 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.

  PMID: 21252654 RESULT

• 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. doi: 10.1016/0016-5085(92)91816-m.

  PMID: 1727765 RESULT

• 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.

  PMID: 22310222 RESULT

• 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.

  PMID: 26341455 RESULT

• 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. No abstract available.

  PMID: 20200386 RESULT

• Lo GH. Management of acute esophageal variceal hemorrhage. Kaohsiung J Med Sci. 2010 Feb;26(2):55-67. doi: 10.1016/s1607-551x(10)70009-7.

  PMID: 20123593 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 10, 2017
• Study Start: May 2, 2017
• Primary Completion: May 1, 2018
• Study Completion: July 16, 2018
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

IN (1)