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Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices

Primary Purpose

Esophageal and Gastric Varices, Ulcer, Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Esophagogastroduodenoscope
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Esophageal and Gastric Varices

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with esophageal varices having upper GIT endoscopy

Exclusion Criteria:

  • Patients having endoscopy with no EVs

Sites / Locations

  • Tanta University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esophagogastroduodenoscope

Arm Description

Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding.

Outcomes

Primary Outcome Measures

Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2014
Last Updated
October 2, 2014
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02256046
Brief Title
Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices
Official Title
Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices; Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices. This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta University, in at least six months in the period from august 2014 to march 2015 or until the target number of patients reached whichever is longer.
Detailed Description
Portal hypertension is a common clinical syndrome, defined by a pathologic increase in the portal venous pressure, in which the hepatic venous pressure gradient (HVPG) is increased above normal values (1-5 mmHg). In cirrhosis, portal hypertension results from the combination of increased intrahepatic vascular resistance and increased blood flow through the portal venous system. Esophageal variceal bleeding is one of the most serious complications of portal hypertension, and represents a leading cause of death in patients with cirrhosis. Each bleeding episode is associated with a 30% mortality rate. Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding. EST consists of the injection of a sclerosing agent into the variceal lumen or adjacent to the varix, with flexible catheter with a needle tip, inducing thrombosis of the vessel and inflammation of the surrounding tissues. During active bleeding, sclerotherapy may achieve hemostasis, inducing variceal thrombosis and external compression by tissue edema. With repeated sessions, the inflammation of the vascular wall and surrounding tissues leads to fibrosis, resulting in variceal obliteration. Furthermore, vascular thrombosis may induce ulcers that also heal, inducing fibrosis. There are technical variations in performing EST, such as type and concentration of the sclerosants, volume injected, interval between sessions, and number of sessions Endoscopic band ligation (EBL) is generally accepted as the treatment of choice for bleeding from esophageal varices. It has shown good results in terms of the control of the active bleeding, with few untoward effects. Esophageal ulcerations ulcerations occur in the esophageal mucosa after all successful ligations. However, ulcers following Esophageal Variceal Ligation (EVL) are less severe than with ES. Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices. . This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta University, in at least six months in the period from august 2014 to march 2015 or until the target number of patients reached whichever is longer. The study include more than 224 patients who undergo endoscopic management of esophageal varices: Methods: All patients will be subjected to: full history taking. -complete clinical examination. -investigations for all groups: i) Complete Blood Count (CBC) ii) liver function tests iii) Kidney function tests. iv) ultrasound on abdomen and pelvis Upper endoscopy at day 0 , follow up endoscopy at day 14 and at 6months End points: ry end point:at 14 days to look for and characterize ulcer if any ry end point: at 6months to look for general and local outcome of intervention Inclusion criteria: Patient with esophageal varices having upper GIT endoscopy Exclusion criteria: Patients having endoscopy with no esophageal varices (EVs) ETHICAL CONSIDERATIONS Unexpected risks during the course of the research will be cleared to the participants and the ethical committee on time , thrombophlebitis may occur during taking blood sample, the investigators will use sterilized techniques during taking sample also bleeding from pinpoint needle track could happen , the investigators will do needle track ablation to avoid it. The investigators will use sterilized techniques during taking sample. Informed consent will be taken and everyone will be given a coded number . Names will not be mentioned ,no pictures will be taken to any part of the body. Results of investigations will be collected, tabulated and statistically analyzed for scientific purposes only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal and Gastric Varices, Ulcer, Cirrhosis, Hypertension, Portal

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophagogastroduodenoscope
Arm Type
Experimental
Arm Description
Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding.
Intervention Type
Device
Intervention Name(s)
Esophagogastroduodenoscope
Other Intervention Name(s)
EGD, upper GI endoscopy
Intervention Description
Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding.
Primary Outcome Measure Information:
Title
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with esophageal varices having upper GIT endoscopy Exclusion Criteria: Patients having endoscopy with no EVs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD'
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ferial Elkalla, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Galal Elkassas, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Elhendawy
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Loai Mansour
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Rabei
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samah Mosaad
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim A Kabbash, MD
Organizational Affiliation
Tanta Faculty of Medicine, Professor
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Elkassas
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Islam S Ismail
Organizational Affiliation
Dr.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim Shebl
Organizational Affiliation
Dr.
Official's Role
Study Director
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
Phone
+20-122-437-8188
Email
asem1967@yahoo.com
First Name & Middle Initial & Last Name & Degree
Asem A Elfert, MD
First Name & Middle Initial & Last Name & Degree
Fat-heya E Assel, MD
First Name & Middle Initial & Last Name & Degree
Ferial Elkalla, MD
First Name & Middle Initial & Last Name & Degree
Galal Elkassas, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Elhendawy
First Name & Middle Initial & Last Name & Degree
Loai Mansour
First Name & Middle Initial & Last Name & Degree
Mohamed Rabei
First Name & Middle Initial & Last Name & Degree
Samah Mosaad
First Name & Middle Initial & Last Name & Degree
Ibrahim Kabbash, MD
First Name & Middle Initial & Last Name & Degree
Mohamed Elkassas
First Name & Middle Initial & Last Name & Degree
Islam S Ismail
First Name & Middle Initial & Last Name & Degree
Ibrahim Shebl

12. IPD Sharing Statement

Citations:
PubMed Identifier
2783677
Citation
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Results Reference
result
PubMed Identifier
3873388
Citation
Garcia-Tsao G, Groszmann RJ, Fisher RL, Conn HO, Atterbury CE, Glickman M. Portal pressure, presence of gastroesophageal varices and variceal bleeding. Hepatology. 1985 May-Jun;5(3):419-24. doi: 10.1002/hep.1840050313.
Results Reference
result
PubMed Identifier
3286356
Citation
Cales P, Pascal JP. [Natural history of esophageal varices in cirrhosis (from origin to rupture)]. Gastroenterol Clin Biol. 1988 Mar;12(3):245-54. No abstract available. French.
Results Reference
result
PubMed Identifier
16374843
Citation
de Franchis R. Endoscopy critics vs. endoscopy enthusiasts for primary prophylaxis of variceal bleeding. Hepatology. 2006 Jan;43(1):24-6. doi: 10.1002/hep.21026. No abstract available.
Results Reference
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PubMed Identifier
18462268
Citation
Garcia-Pagan JC, De Gottardi A, Bosch J. Review article: the modern management of portal hypertension--primary and secondary prophylaxis of variceal bleeding in cirrhotic patients. Aliment Pharmacol Ther. 2008 Jul;28(2):178-86. doi: 10.1111/j.1365-2036.2008.03729.x. Epub 2008 May 2.
Results Reference
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PubMed Identifier
15094222
Citation
Villanueva C, Lopez-Balaguer JM, Aracil C, Kolle L, Gonzalez B, Minana J, Soriano G, Guarner C, Balanzo J. Maintenance of hemodynamic response to treatment for portal hypertension and influence on complications of cirrhosis. J Hepatol. 2004 May;40(5):757-65. doi: 10.1016/j.jhep.2004.01.017.
Results Reference
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PubMed Identifier
18346683
Citation
Villanueva C, Colomo A, Aracil C, Guarner C. Current endoscopic therapy of variceal bleeding. Best Pract Res Clin Gastroenterol. 2008;22(2):261-78. doi: 10.1016/j.bpg.2007.11.012.
Results Reference
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PubMed Identifier
10643628
Citation
de Franchis R, Primignani M. Endoscopic treatments for portal hypertension. Semin Liver Dis. 1999;19(4):439-55. doi: 10.1055/s-2007-1007131.
Results Reference
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PubMed Identifier
1421595
Citation
Westaby D. Emergency and elective endoscopic therapy for variceal haemorrhage. Baillieres Clin Gastroenterol. 1992 Sep;6(3):465-80. doi: 10.1016/0950-3528(92)90033-b. No abstract available.
Results Reference
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Citation
Villanueva C, Sancho-Poch F, Balanz Jea. Esophagic Histophathologic changes induced by variceal sclerosing therapy. Gastroenterol Hepatol 1990; 13: 15-19
Results Reference
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PubMed Identifier
11328251
Citation
Helmy A, Hayes PC. Review article: current endoscopic therapeutic options in the management of variceal bleeding. Aliment Pharmacol Ther. 2001 May;15(5):575-94. doi: 10.1046/j.1365-2036.2001.00950.x.
Results Reference
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PubMed Identifier
8495829
Citation
Young MF, Sanowski RA, Rasche R. Comparison and characterization of ulcerations induced by endoscopic ligation of esophageal varices versus endoscopic sclerotherapy. Gastrointest Endosc. 1993 Mar-Apr;39(2):119-22. doi: 10.1016/s0016-5107(93)70049-8.
Results Reference
result

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Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices

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