Portal HypertensionNCT02635815
Risk Factors for Variceal Bleeding in Egyptian Patients With Non-Cirrhotic Portal Hypertension
An observational study of Portal Hypertension, run by Ain Shams University.
Trial summary
Background \& Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of variceal bleeding in an Egyptian cohort with NCPH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Upper gastrointestinal endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices, presenting with or without variceal bleeding
Who may be able to join
- Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices
Who cannot join
- Patients with concomitant infection with viral hepatitis, cirrhotic portal hypertension, hepatocellular carcinoma as well as those with other sources of bleeding such as erosions or ulcers were excluded
About this study
Background \& Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of variceal bleeding in an Egyptian cohort with NCPH.
Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were included. All underwent complete clinical evaluation, laboratory investigations, Color Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper gastrointestinal endoscopy. Patients were classified into two groups according to variceal bleeding: (1) Group I: twenty six patients with history of bleeding or had an attack of bleeding during one year follow-up; and (2) Group II: thirty four patients without bleeding.
Read the detailed description
All of the included patients underwent: (1) A complete clinical evaluation; (2) Laboratory investigations: CBC, liver profile, viral markers (HBs Ag, HB core Ab, HCV Ab) using the ELISA technique; (3) Thrombophilia workup to clarify the underlying etiology of vascular liver disease. It was done only for patients with Budd-Chiari syndrome and extrahepatic portal vein thrombosis: anticardiolipin antibodies, lupus anticoagulant, antinuclear antibodies, protein C, S, antithrombin III, factor V Leiden G1691A mutation, prothrombin gene G20210A mutation, methylene tetrahydrofolate reductase C677T mutation by PCR, Janus tyrosine kinase-2 (JAK II) V617F mutation by PCR (to exclude myeloproliferative disorders) and flow cytometry for CD55 and CD59 (to exclude paroxysmal nocturnal hemoglobinuria); (4) Abdominal ultrasonography: for liver size, echogenicity, spleen size, portal vein diameter and ascites; (5) Color Doppler ultrasonographic study: was done in the morning after an overnight fasting using a color Doppler unit with a 3.5 MHz convex probe for confirmation of portal vein (PV) patency and diameter, mean PV flow velocity (mean PVV) (cm/sec), PV direction of flow, splenic vein patency and diameter, presence of portosystemic collaterals and patency of hepatic veins; (6) Platelet count/spleen diameter ratio: calculated as: platelet count/ maximum spleen bipolar diameter by ultrasound in mm; (7) Ultrasonography guided liver biopsy: for diagnosis of NCPH and exclusion of cirrhotic portal hypertension; and (8) Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440. Oesophageal varices were classified according to their size into small, medium or large [8]. Prophylaxis with band ligation was done to patients with large or medium sized risky varices who were eligible for starting anticoagulation. The diagnosis of variceal bleeding was confirmed if an actively bleeding varix or a varix with adherent clot or white nipple was seen. Red color signs were classified into Cherry Red Spots "CRS", Red Wale Markings "RWM" and Hematocystic Spots "HCS". Gastric varices were classified into either gastro-esophageal varices (GEV) or isolated gastric varices (IGV). Portal hypertensive gastropathy (PHG) was classified into either mild or severe.
- Conditions
- Portal Hypertension
- Being tested
- Upper gastrointestinal endoscopy
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper gastrointestinal endoscopyProcedure or surgery
Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440
| Study group | Role | What they receive |
|---|---|---|
| Group I | twenty six patients with history of bleeding or had an attack of bleeding during one year follow-up. All underwent upper gastrointestinal endoscopy. Receives: Procedure: Upper gastrointestinal endoscopy | |
| Group II | thirty four patients without bleeding. All underwent upper gastrointestinal endoscopy. Receives: Procedure: Upper gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence or absence of variceal bleeding within one year of follow up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdelhakam, Ain Shams University
- Investigators
- Reda Elwakil, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635815
- Sponsor's protocol ID
- 699
- Status last verified
- Mar 2016
- First submitted
- 17 Dec 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Variceal Bleeding in Egyptian Patients With Non-Cirrhotic Portal Hypertension
- ClinicalTrials.gov ID
- NCT02635815
- Acronym / sponsor ID
- 699
- Conditions
- Portal Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 21 Dec 2015 (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.
Background \& Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of variceal bleeding in an Egyptian cohort with NCPH.
Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were included. All underwent complete clinical evaluation, laboratory investigations, Color Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper gastrointestinal endoscopy. Patients were classified into two groups according to variceal bleeding: (1) Group I: twenty six patients with history of bleeding or had an attack of bleeding during one year follow-up; and (2) Group II: thirty four patients without bleeding.
Detailed description
All of the included patients underwent: (1) A complete clinical evaluation; (2) Laboratory investigations: CBC, liver profile, viral markers (HBs Ag, HB core Ab, HCV Ab) using the ELISA technique; (3) Thrombophilia workup to clarify the underlying etiology of vascular liver disease. It was done only for patients with Budd-Chiari syndrome and extrahepatic portal vein thrombosis: anticardiolipin antibodies, lupus anticoagulant, antinuclear antibodies, protein C, S, antithrombin III, factor V Leiden G1691A mutation, prothrombin gene G20210A mutation, methylene tetrahydrofolate reductase C677T mutation by PCR, Janus tyrosine kinase-2 (JAK II) V617F mutation by PCR (to exclude myeloproliferative disorders) and flow cytometry for CD55 and CD59 (to exclude paroxysmal nocturnal hemoglobinuria); (4) Abdominal ultrasonography: for liver size, echogenicity, spleen size, portal vein diameter and ascites; (5) Color Doppler ultrasonographic study: was done in the morning after an overnight fasting using a color Doppler unit with a 3.5 MHz convex probe for confirmation of portal vein (PV) patency and diameter, mean PV flow velocity (mean PVV) (cm/sec), PV direction of flow, splenic vein patency and diameter, presence of portosystemic collaterals and patency of hepatic veins; (6) Platelet count/spleen diameter ratio: calculated as: platelet count/ maximum spleen bipolar diameter by ultrasound in mm; (7) Ultrasonography guided liver biopsy: for diagnosis of NCPH and exclusion of cirrhotic portal hypertension; and (8) Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440. Oesophageal varices were classified according to their size into small, medium or large [8]. Prophylaxis with band ligation was done to patients with large or medium sized risky varices who were eligible for starting anticoagulation. The diagnosis of variceal bleeding was confirmed if an actively bleeding varix or a varix with adherent clot or white nipple was seen. Red color signs were classified into Cherry Red Spots "CRS", Red Wale Markings "RWM" and Hematocystic Spots "HCS". Gastric varices were classified into either gastro-esophageal varices (GEV) or isolated gastric varices (IGV). Portal hypertensive gastropathy (PHG) was classified into either mild or severe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Upper gastrointestinal endoscopytwenty six patients with history of bleeding or had an attack of bleeding during one year follow-up. All underwent upper gastrointestinal endoscopy. |
| Group II | – | Procedure: Upper gastrointestinal endoscopythirty four patients without bleeding. All underwent upper gastrointestinal endoscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices, presenting with or without variceal bleeding
Key inclusion criteria (1 listed)
- Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices
Key exclusion criteria (1 listed)
- Patients with concomitant infection with viral hepatitis, cirrhotic portal hypertension, hepatocellular carcinoma as well as those with other sources of bleeding such as erosions or ulcers were excluded
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 |
|---|---|---|
| Upper gastrointestinal endoscopyUpper gastrointestinal endoscopy using the Pentax video endoscope EG 3440 | Procedure or surgery | Group I, Group II |
Primary outcome
The presence or absence of variceal bleeding within one year of follow up.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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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.
Reda Elwakil, Professor study director
Ain Shams University
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension, run by Ain Shams University.
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: finished, as of the sponsor's last update on 4 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence or absence of variceal bleeding within one year of follow up. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2016.