Esophageal and Gastric VaricesNCT02256046
Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices
A study testing Esophagogastroduodenoscope in people with Esophageal and Gastric Varices and Ulcer, run by Tanta University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal and Gastric Varices, Ulcer, Cirrhosis
- What is being tested?
- Esophagogastroduodenoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with esophageal varices having upper GIT endoscopy
Who cannot join
- Patients having endoscopy with no EVs
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University Hospital
Tanta, Gharbia Governorate, 31111
Asem A Elfert, MD, +20-122-437-8188, asem1967@yahoo.com
Asem A Elfert, MD
About this study
Official title: Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices; Multicenter Study
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.
Read the 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.
- Conditions
- Esophageal and Gastric Varices, Ulcer, Cirrhosis, Hypertension, Portal
- Being tested
- Esophagogastroduodenoscope
- Medical subject headings
- Esophageal and Gastric Varices, Ulcer, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogastroduodenoscopeDevice
Also called EGD, upper GI endoscopy
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.
| Study group | Role | What they receive |
|---|---|---|
| Esophagogastroduodenoscope | Experimental | 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. Receives: Device: Esophagogastroduodenoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Shebl, Tanta University
- Investigators
- Asem A Elfert, MD, Principal investigator, Tanta Faculty of Medicine, ProfessorFat-heya E Assel, MD', Study director, Tanta Faculty of Medicine, ProfessorFerial Elkalla, MD, Study director, Tanta Faculty of Medicine, ProfessorGalal Elkassas, MD, Study director, Tanta Faculty of Medicine, ProfessorMohamed Elhendawy, Study director, Dr.Loai Mansour, Study director, Dr.Mohamed Rabei, Study director, Dr.Samah Mosaad, Study director, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256046
- Sponsor's protocol ID
- esophageal ulcers
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2014
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rigau J, Bosch J, Bordas JM, Navasa M, Mastai R, Kravetz D, Bruix J, Feu F, Rodes J. Endoscopic measurement of variceal pressure in cirrhosis: correlation with portal pressure and variceal hemorrhage. Gastroenterology. 1989 Mar;96(3):873-80.
PubMed 2783677Garcia-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.
PubMed 3873388Cales 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.
PubMed 3286356de 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.
PubMed 16374843Garcia-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.
PubMed 18462268Villanueva 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.
PubMed 15094222Villanueva 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.
PubMed 18346683de Franchis R, Primignani M. Endoscopic treatments for portal hypertension. Semin Liver Dis. 1999;19(4):439-55. doi: 10.1055/s-2007-1007131.
PubMed 10643628Westaby 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.
PubMed 1421595Villanueva C, Sancho-Poch F, Balanz Jea. Esophagic Histophathologic changes induced by variceal sclerosing therapy. Gastroenterol Hepatol 1990; 13: 15-19
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.
PubMed 11328251Young 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.
PubMed 8495829
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices; Multicenter Study
- ClinicalTrials.gov ID
- NCT02256046
- Acronym / sponsor ID
- esophageal ulcers
- Conditions
- Esophageal and Gastric Varices, Ulcer, Cirrhosis, Hypertension, Portal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophagogastroduodenoscope | Experimental | Device: EsophagogastroduodenoscopeEndoscopic 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with esophageal varices having upper GIT endoscopy
Key exclusion criteria (1 listed)
- Patients having endoscopy with no EVs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsophagogastroduodenoscopeAlso: EGD, upper GI endoscopyEndoscopic 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. | Device | Esophagogastroduodenoscope |
Primary outcome
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2014.
- Results publication: PubMed 2783677Rigau J, Bosch J, Bordas JM, Navasa M, Mastai R, Kravetz D, Bruix J, Feu F, Rodes J. Endoscopic measurement of variceal pressure in cirrhosis: correlation with portal pressure and variceal hemorrhage. Gastroenterology. 1989 Mar;96(3):873-80.
- Results publication: PubMed 3873388Garcia-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 publication: PubMed 3286356Cales 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 publication: PubMed 16374843de 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 publication: PubMed 18462268Garcia-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 publication: PubMed 15094222Villanueva 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 publication: PubMed 18346683Villanueva 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 publication: PubMed 10643628de Franchis R, Primignani M. Endoscopic treatments for portal hypertension. Semin Liver Dis. 1999;19(4):439-55. doi: 10.1055/s-2007-1007131.
- Results publication: PubMed 1421595Westaby 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 publicationVillanueva C, Sancho-Poch F, Balanz Jea. Esophagic Histophathologic changes induced by variceal sclerosing therapy. Gastroenterol Hepatol 1990; 13: 15-19
- Results publication: PubMed 11328251Helmy 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 publication: PubMed 8495829Young 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.
Related trials for Esophageal and Gastric Varices
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Not yet recruitingObservational study
Baveno VIII Criteria for Portal Hypertension in Egyptian Patients
Compensated Liver Disease, Esophageal Varices
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial Investigating the Impact of Fasting Duration on Postoperative Rebleeding Following Esophageal Variceal Ligation.
Esophageal Varices
Not yet recruitingObservational study
Clinical Trial to Evaluate the Effectiveness of Liver Shear Wave Quantization Detector Spleen Stiffness Value in the Diagnosis of Esophageal Varices
Chronic Liver Diseases, Spleen Stiffness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asem A Elfert, MD principal investigator
Tanta Faculty of Medicine, Professor
Fat-heya E Assel, MD' study director
Tanta Faculty of Medicine, Professor
Ferial Elkalla, MD study director
Tanta Faculty of Medicine, Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagogastroduodenoscope in people with Esophageal and Gastric Varices and Ulcer, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asem A Elfert, MD (+20-122-437-8188, asem1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02256046, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2014.