Acute Gastroesophageal Variceal Bleeding Clinical Trial
Official title:
Comparison of Early Vs Delayed Feeding on Rebleeding Following Endoscopic Ligation for Acute Esophageal Variceal Bleeding
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.
There has not been much studies conducted to address this issue however most of the
recommendations are made in view of preventing any complications following procedures.
Stiegmann and Goff 4 were the first to employ EVL to treat esophageal varices. They did not
mention any specific restriction of feeding on patients receiving band ligation however they
did mentioned that following the band ligation of varices, the ligated varices and tissues
may evoke transient dysphagia to solid food.5 A study conducted by Gin Ho Lo et al 6
demonstrated that early feeding with a liquid diet in conscious patients after successful
endoscopic therapy of varices can shorten the hospital stay. The two groups which were
created in this study were the early-feeding group and the delayed-feeding group. Patients in
the early-feeding group were asked to fast for only 4 hours following endoscopic treatment.
Subsequently, a liquid diet (fruit juice, soybean juice, milk, rice in liquid form) was
instituted for 3 days. Additionally, <500 cc intravenous fluid with proper electrolyte
supplement per day was administered. Thereafter, a soft diet was provided for 3 days, after
which a regular diet was resumed since the seventh day after endoscopic treatment. Patients
in the delayed-feeding group were asked to absolutely fast for 48 hours after endoscopic
treatment, and 1500 cc/day intravenous fluids (normal saline or glucose water) with proper
electrolytes were administered for 2 days. After 2 days of fasting, a liquid diet was given
for 1 day, and subsequently, a soft diet was given for 3 days, and then a regular diet was
instituted on the seventh day after endoscopic treatment. If rebleeding occurred within 7
days of endoscopic therapy, patients in both groups were again asked to fast for 48 hours,
and then put on a liquid diet for 1 day followed by a soft diet for 4 days.
Treatment failure was defined as failure to control acute bleeding episodes or very early
rebleeding or death within 5 days. Failure to control acute variceal bleeding was defined as
the occurrence of any of the following events within 48 hours of enrollment, based on the
modified criteria of the Baveno III consensus:7 (1) fresh hematemesis after enrollment; (2)
sudden onset of reduction in blood pressure of _20 mmHg and/or an increase in pulse rate of
20 beats/minute with 2 g drop in hemoglobin; (3) transfusion of four units of blood required
to increase the hematocrit to above 27% or hemoglobin to above 9 g/dL; and (4) death. Very
early rebleeding was defined as when the criteria for failure to control acute variceal
bleeding occurred between 48 hours and 120 hours after enrollment in patients achieving
control of acute bleeding. Control of acute bleeding (initial hemostasis) was defined as when
the criteria for failure did not occur within 48 hours of enrollment. A 5-day hemostasis was
defined as when the criteria for failure to control acute variceal bleeding and very early
rebleeding did not occur within 5 days of enrollment. A nasogastric tube was not routinely
inserted after initial endoscopy.
The rebleeding rates associated with EVL varied greatly between studies, and rates ranging
from 2% to 54% have been recorded.8,9 Aside from other reasons, this discrepancy is very
likely to be related to the variation in timing of refeeding after EVL. However, this factor
was rarely mentioned in the methodology of these studies A review article by Xavier
He´buterne 10 concluded that In patients hospitalized for acute upper gastrointestinal
bleeding due to an ulcer with high risk of rebleeding (Forrest I-IIb) or with variceal
bleeding it is recommended to wait at least 48 h after endoscopic therapy before initiating
oral or enteral feeding. In case of ulcer with low risk of rebleeding (Forrest IIc and III)
or in patients with gastritis, Mallory-Weiss, oesophagitis, or angiodysplasia, there is no
need to delay refeeding, and they can be fed as soon as tolerated. Understanding the cause of
the diagnosis is always necessary to adapt nutrition in patients with upper gastrointestinal
bleeding.
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