Skip to content

Trial · Interventional

Status unknownPhase 4Registry data

Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

NCTNCT05199038 (opens ClinicalTrials.gov in a new tab)Other idEsophageal Varices Rebleeding
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
184 participants (estimated)
Sponsor
Tanta University · Other
Design
Randomized · Single masking
Countries
Not stated
Start
Jun 2022 (estimated)
Primary completion
Jun 2023 (estimated)
Completion
Nov 2023 (estimated)
First posted
20 Jan 2022
Last update posted
18 May 2022
Conditions
Esophageal Varices

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024
  1. Ph 4

    Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study

    NCT05199038

    est. Jun 2022 to est. Nov 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this study is to compare the efficacy of 2-days versus 5-days octreotide infusion after endoscopic therapy in preventing early esophageal varices rebleed in patients with cirrhosis.

Interventions

  • OctreotideDrug

Arms2

  • Experimental

    2 Days of octreotide infusion

  • Active comparator

    5 Days of octreotide infusion

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Esophageal varices rebleed within 5days after control of initial bleed

    Time frame · with in 5 days after controlof initial bleeding

    Registry description

    5 days Rebleeding means 1. Recurrence of hematemesis or melena after bleeding control 2. Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100 3. A drop in hemoglobin by more than 20 percentage points from baseline 4. Transfusion of \>2 unites packed red blood cells after endoscopic intervention of variceal bleeding

Secondary outcomes(1)

  1. Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed

    Time frame · 5 days - 6 weeks after control of initial bleeding

    Registry description

    5days-6weeks rebleed means 1. Any new episode of hematemesis, melena, or hematochezia (with sustained tachycardia more than 100 beat/min and drop of systolic blood pressure less than 100) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

12 results

Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage.

Seo et al. 2014Hepatology (Baltimore, Md.)cited by 141

PMID 24415445DOI 10.1002/hep.27006PUB-24415445

Rights unknown12 results
Source linkSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Acute esophageal varices bleeding 2. Liver cirrhosis Exclusion Criteria: 1. Initial failure to control variceal bleed on endoscopy 2. Other causes of GIT bleeding 3. Hepatocellular carcinoma 4. Portal vein thrombosis 5. Renal dialysis and hepatorenal syndrome 6. History of myocardial infarction 7. Pregnancy or lactation 8. Allergy to octreotide

PepBank is a research reference. Talk to a doctor before you use any peptide.