Varices Clinical Trial
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.
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:
1. The etiology of portal hypertension is cirrhosis.
2. Age ranges between 20-80 y/o.
3. 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.
4. 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:
1) 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05538546 -
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
|
||
| Recruiting |
NCT06392503 -
Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis
|
||
| Recruiting |
NCT05511766 -
Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis
|
Phase 2/Phase 3 |