Clinical trial NCT01267669: A Trial of Somatostatin With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Official title: A Double Blind Randomized Placebo-Controlled Trial of Somatostatin in Association With Endoscopic Variceal Ligation (EVL) in Control of Acute Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Bleeding Esophageal Varices
Portal Hypertension
Cirrhosis
Keywords: Variceal bleeding
Endoscopic therapy
Band ligation
Somatostatin
Vasoactive drugs
Octreotide
Lead sponsor: Govind Ballabh Pant Hospital
Sponsor class: OTHER_GOV
First posted: 2010-12-28
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Efficacy of endoscopic variceal sclerotherapy in achieving initial control of acute variceal bleeding and five-day haemostasis has been shown to significantly improve when vasoactive drug is added. However, there is limited data whether addition of somatostatin, to endoscopic variceal ligation (EVL) improves the efficacy of EVL.

Aim: To compare EVL plus somatostatin versus EVL plus placebo in control of acute variceal bleeding.

Patients and methods: Consecutive cirrhotic patients with acute variceal bleeding from esophageal varices were enrolled in the trial. After emergency EVL, patients were randomized to receive either somatostatin (250 mcg/hr) or placebo infusion. Primary endpoint was treatment failure within 5 days. Treatment failure was defined as fresh hematemesis ≥2 hour after start of therapy or death.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of portal hypertension
* Having hematemesis and/or melena within 24 hour prior to admission
* Source of bleeding should be esophageal varices

Exclusion Criteria:

* Non-cirrhotic cause of portal hypertension
* Age \<12 or \>75 years
* Hepatic encephalopathy grade 3 or 4
* Renal failure with serum creatinine \>2 mg/dL
* Any evidence of bleeding from additional source apart from esophageal varices (like gastric varices, portal hypertensive gastropathy, erosions or ulcers including variceal ulcers)
* Patients already on vasoactive drugs like somatostatin or terlipressin during the current episode of bleeding
* Patients already received EVL or EST elsewhere during the current episode of bleeding prior to presenting to our hospital
* Patients with history of surgery for portal hypertension or TIPS
* Concomitant severe cardio-pulmonary disease
* Concomitant malignancy
* HVPG not possible within 24 hrs of presentation
* Patients refusing to participate in the study.

Primary outcomes:
measure: Treatment failure
timeFrame: 5 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: During the same admission
measure: Transfusion requirement
timeFrame: During hospital stay
measure: ICU stay in days
timeFrame: During the hospital stay
measure: Drug-related adverse effects
timeFrame: 5 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Department of Gastroenterology, G B Pant Hospital
state: Delhi
Study officials:
affiliation: G B Pant Hospital
name: Shiv K Sarin, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar A, Jha SK, Mittal VV, Sharma P, Sharma BC, Sarin SK. Addition of Somatostatin After Successful Endoscopic Variceal Ligation Does not Prevent Early Rebleeding in Comparison to Placebo: A Double Blind Randomized Controlled Trial. J Clin Exp Hepatol. 2015 Sep;5(3):204-12. doi: 10.1016/j.jceh.2015.06.001. Epub 2015 Jun 16.