Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study
Primary Purpose
Esophageal Varices
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Octreotide
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Varices
Eligibility Criteria
Inclusion Criteria:
- Acute esophageal varices bleeding
- Liver cirrhosis
Exclusion Criteria:
- Initial failure to control variceal bleed on endoscopy
- Other causes of GIT bleeding
- Hepatocellular carcinoma
- Portal vein thrombosis
- Renal dialysis and hepatorenal syndrome
- History of myocardial infarction
- Pregnancy or lactation
- Allergy to octreotide
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2 Days of octreotide infusion
5 Days of octreotide infusion
Arm Description
Outcomes
Primary Outcome Measures
Esophageal varices rebleed within 5days after control of initial bleed
5 days Rebleeding means
Recurrence of hematemesis or melena after bleeding control
Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100
A drop in hemoglobin by more than 20 percentage points from baseline
Transfusion of >2 unites packed red blood cells after endoscopic intervention of variceal bleeding
Secondary Outcome Measures
Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed
5days-6weeks rebleed means
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)
Drop in hemoglobin by more than 20 percentage points OR the need for >2 units packed red blood cells
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05199038
Brief Title
Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study
Official Title
Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
Variceal hemorrhage, causative of 70% of all upper gastrointestinal (GIT) bleeding events in patients with portal hypertension, remains one of the most severe and immediate life-threatening complications in patients with cirrhosis and constitutes the second most frequent decompensating event after ascites .
Gastro-esophageal varices are identified in about 30% of patients with compensated cirrhosis and 60% of patients with de-compensated cirrhosis . Esophageal variceal bleeding (EVB) occurs in 10-20% of cirrhotic patients per year and each bleeding episode can be associated with in-hospital mortality .
Mortality during the first episode is estimated to 15-20% but is higher in severe patients (Child Pugh C), at around 30%, whereas it is very low in patients with compensated cirrhosis (Child Pugh A) .The main predictors of bleeding in clinical practice are: large versus small varices, red wale marks, Child Pugh C versus Child Pugh A-B .
Treatment of variceal bleeding should be started as soon as bleeding is clinically confirmed, regardless the lack of confirmation by upper endoscopy . Initial therapy should be directed at restoring blood volume. Vasoactive drug therapy and antibiotic prophylaxis should be initiated as soon as AVB is suspected. Goals of therapy in AVB include the control of bleeding, as well as the prevention of early recurrence and the prevention of six-week mortality .
Starting vasoactive drugs before endoscopy decreases the incidence of active bleeding during endoscopy and facilitates endoscopic therapy, improving the control of bleeding, and potentially survival. Terlipressin, somatostatin or octreotide are accepted drugs with proven efficacy .
Once AVB is confirmed, vasoactive drug therapy should be administered for five days to avoid early rebleeding. Shorter administration of vasoactive drugs (48-72 h) can be considered in less severe episodes although more data are required .The optimal duration of pharmacological therapy has not been well established. In randomized-controlled trials, the duration of vasoactive drugs has varied between 8 h and 6 days .
There was a major agreement that an appropriate length of therapy would be anywhere between 2 and 5 days depending on control of hemorrhage and the presence or absence of predictors of rebleeding .
The combination of endoscopic therapy and vasoactive drugs is more effective than the isolated use of either of these options alone, because it combines the local haemostatic effect on the varices induced by endoscopic treatment and the portal hypotensive effect achieved with drugs. This combination is currently considered the standard of care in AVB .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
184 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2 Days of octreotide infusion
Arm Type
Experimental
Arm Title
5 Days of octreotide infusion
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Octreotide
Intervention Description
Octreotide infusion for 2 days in patients with bleeding esophageal varices.
Primary Outcome Measure Information:
Title
Esophageal varices rebleed within 5days after control of initial bleed
Description
5 days Rebleeding means
Recurrence of hematemesis or melena after bleeding control
Sustained tachycardia more than 100 beat/ min and sudden drop of systolic blood pressure less than 100
A drop in hemoglobin by more than 20 percentage points from baseline
Transfusion of >2 unites packed red blood cells after endoscopic intervention of variceal bleeding
Time Frame
with in 5 days after controlof initial bleeding
Secondary Outcome Measure Information:
Title
Esophageal varices rebleed at 5 days and 6 weeks after control of initial bleed
Description
5days-6weeks rebleed means
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)
Drop in hemoglobin by more than 20 percentage points OR the need for >2 units packed red blood cells
Time Frame
5 days - 6 weeks after control of initial bleeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Acute esophageal varices bleeding
Liver cirrhosis
Exclusion Criteria:
Initial failure to control variceal bleed on endoscopy
Other causes of GIT bleeding
Hepatocellular carcinoma
Portal vein thrombosis
Renal dialysis and hepatorenal syndrome
History of myocardial infarction
Pregnancy or lactation
Allergy to octreotide
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mennat -Allah M. El Sawaf, master
Phone
00201225548976
Email
mennaallah.elsawaf@med.tanta.edu.eg
12. IPD Sharing Statement
Citations:
PubMed Identifier
29653741
Citation
European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018 Aug;69(2):406-460. doi: 10.1016/j.jhep.2018.03.024. Epub 2018 Apr 10. No abstract available. Erratum In: J Hepatol. 2018 Nov;69(5):1207.
Results Reference
background
PubMed Identifier
28852523
Citation
Mallet M, Rudler M, Thabut D. Variceal bleeding in cirrhotic patients. Gastroenterol Rep (Oxf). 2017 Aug;5(3):185-192. doi: 10.1093/gastro/gox024. Epub 2017 Jul 21.
Results Reference
background
PubMed Identifier
28533909
Citation
Haq I, Tripathi D. Recent advances in the management of variceal bleeding. Gastroenterol Rep (Oxf). 2017 May;5(2):113-126. doi: 10.1093/gastro/gox007. Epub 2017 Apr 7.
Results Reference
background
PubMed Identifier
20200386
Citation
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. Erratum In: N Engl J Med. 2011 Feb 3;364(5):490. Dosage error in article text.
Results Reference
background
PubMed Identifier
24415445
Citation
Seo YS, Park SY, Kim MY, Kim JH, Park JY, Yim HJ, Jang BK, Kim HS, Hahn T, Kim BI, Heo J, An H, Tak WY, Baik SK, Han KH, Hwang JS, Park SH, Cho M, Um SH. Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage. Hepatology. 2014 Sep;60(3):954-63. doi: 10.1002/hep.27006. Epub 2014 Jul 25.
Results Reference
background
PubMed Identifier
22178268
Citation
Azam Z, Hamid S, Jafri W, Salih M, Abbas Z, Abid S, Shah H. Short course adjuvant terlipressin in acute variceal bleeding: a randomized double blind dummy controlled trial. J Hepatol. 2012 Apr;56(4):819-24. doi: 10.1016/j.jhep.2011.11.019. Epub 2011 Dec 16.
Results Reference
background
PubMed Identifier
21484145
Citation
Sarin SK, Kumar A, Angus PW, Baijal SS, Baik SK, Bayraktar Y, Chawla YK, Choudhuri G, Chung JW, de Franchis R, de Silva HJ, Garg H, Garg PK, Helmy A, Hou MC, Jafri W, Jia JD, Lau GK, Li CZ, Lui HF, Maruyama H, Pandey CM, Puri AS, Rerknimitr R, Sahni P, Saraya A, Sharma BC, Sharma P, Shiha G, Sollano JD, Wu J, Xu RY, Yachha SK, Zhang C; Asian Pacific Association for the Study of the Liver (APASL) Working Party on Portal Hypertension. Diagnosis and management of acute variceal bleeding: Asian Pacific Association for Study of the Liver recommendations. Hepatol Int. 2011 Jun;5(2):607-24. doi: 10.1007/s12072-010-9236-9. Epub 2011 Feb 19.
Results Reference
background
PubMed Identifier
17879356
Citation
Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052.
Results Reference
background
PubMed Identifier
16904224
Citation
Villanueva C, Piqueras M, Aracil C, Gomez C, Lopez-Balaguer JM, Gonzalez B, Gallego A, Torras X, Soriano G, Sainz S, Benito S, Balanzo J. A randomized controlled trial comparing ligation and sclerotherapy as emergency endoscopic treatment added to somatostatin in acute variceal bleeding. J Hepatol. 2006 Oct;45(4):560-7. doi: 10.1016/j.jhep.2006.05.016. Epub 2006 Jun 28.
Results Reference
background
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Comparison of 2 Days Versus 5 Days of Octreotide After Endoscopic Therapy in Preventing Early Esophageal Varices Rebleed : A Randomized Controlled Study
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