Esophageal Varices Secondary to Cirrhosis of LiverNCT01426087
Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
A study testing Somatostatin and endoscopic therapy in people with Esophageal Varices Secondary to Cirrhosis of Liver, run by Yunsheng Yang at 1 site in China.
Trial summary
The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Varices Secondary to Cirrhosis of Liver
- What is being tested?
- Somatostatin and endoscopic therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Dec 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis with esophageal gastric varices needed endoscopic therapy
- Age 18-75 years
- Informed written consent
Who cannot join
- Use of vasoactive drugs 24 hours before endoscopic treatment
- Use of B-blocker within 1 week
- Previous surgical or endoscopic treatment for esophageal gastric varices
- Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy
- Gastro-renal vein shunt
- Severe hepatic hydrothorax
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- Hepatocellular carcinoma with portal vein thrombosis
- Severe coagulation disorders
- Severe active bacteria infection
- Severe cardiovascular disease, including a history of acute myocardial infarction,heart block, heart failure
- Severe renal function insufficiency （Calculated Creatinine Clearance Rate (Ccr) <30ml/min）
- Severe co-morbidity that would affect short-term prognosis
- Pregnancy or lactation
- Allergy to any ingredient of trial medication
- Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Site
Beijing, 010
Yun Sh Yang, Pro., 010-66936115
Yun Sh Yang, Professor
About this study
Official title: Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. In the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.
Read the detailed description
126 patients will be enrolled in the study, 63 subjects will be randomized into the group A and the other will be into the group B.
Group A: endoscopic therapy and somatostatin treatment. Group B: endoscopic therapy.
- Being tested
- Somatostatin, endoscopic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatostatinDrug
Also called stilamin
giving stilamin 250ug/h after endoscopic therapy for 5 days
endoscopic therapyProcedure or surgery
Also called antisterone,DHCT,albumin or antibiotics
gastroscope plus EIS/EVL/HI
| Study group | Role | What they receive |
|---|---|---|
| endoscopic and somatostatin treatment | Experimental | Not described Receives: Drug: Somatostatin |
| endoscopic therapy | Other | Not described Receives: Procedure: endoscopic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal vein blood flow volume
Note:
- Portal vein blood flow volume will be measured by doppler ultrasound device.
- Values are the mean of three consecutive measurements.
- Frequency: PVF will be measured on baseline, day1, day 5 and day 7.
- All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation.
Measured: change from baseline in portal vein blood flow volume after 7 days treatment
Secondary outcomes (3)
Portal vein diameter (PVD mm)
Portal vein diameter will be measured by doppler ultrasound device.
Measured: change from baseline in PDV after 7 days treatment
Mean portal vein blood velocity (PVV cm/s)
PVV will be measured by doppler ultrasound device.
Measured: change from baseline in PVV after 7 days treatment
Ascites volume
Sonography detecting site: the middle point of the line between navel and the right side of anterior superior iliac spine(ASIS)
Measured: change from baseline after 7 days treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Varices Secondary to Cirrhosis of LiverStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunsheng Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunsheng Yang, Chinese PLA General Hospital
- Investigators
- Yun Sh Yang, Pro., Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426087
- Sponsor's protocol ID
- 0105467801
- Status last verified
- Aug 2011
- First submitted
- 29 Aug 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Sponsored Study of Effects of Somatostatin on Post-endoscopic Portal Hemodynamic in Cirrhotic Patients With Esophageal Gastric Varices
- ClinicalTrials.gov ID
- NCT01426087
- Acronym / sponsor ID
- 0105467801
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Yunsheng YangUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 31 Aug 2011 (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.
The main complications of cirrhosis are ascites, esophageal varices and hepatic encephalopathy. About 30% to 70% patients with cirrhosis occur esophageal varices, and the most common complication is ascites. Somatostatin is used to treat esophageal for a long time, otherwise it could aslo prevent ascites. In the study, the investigators explore the effects of somatostatin on post-endoscopic portal hemodynamic in cirrhotic patients with esophageal gastric varices.
Detailed description
126 patients will be enrolled in the study, 63 subjects will be randomized into the group A and the other will be into the group B.
Group A: endoscopic therapy and somatostatin treatment. Group B: endoscopic therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endoscopic and somatostatin treatment | Experimental | Drug: Somatostatin |
| endoscopic therapy | Other | Procedure: endoscopic therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cirrhosis with esophageal gastric varices needed endoscopic therapy
- Age 18-75 years
- Informed written consent
Key exclusion criteria (15 listed)
- Use of vasoactive drugs 24 hours before endoscopic treatment
- Use of B-blocker within 1 week
- Previous surgical or endoscopic treatment for esophageal gastric varices
- Hepatic encephalopathy,comatose status and any other disease which could not accept endoscopic therapy
- Gastro-renal vein shunt
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 |
|---|---|---|
| SomatostatinAlso: stilamingiving stilamin 250ug/h after endoscopic therapy for 5 days | Drug | endoscopic and somatostatin treatment |
| endoscopic therapyAlso: antisterone,DHCT,albumin or antibioticsgastroscope plus EIS/EVL/HI | Procedure or surgery | endoscopic therapy |
Primary outcome
Portal vein blood flow volume
Time frame: change from baseline in portal vein blood flow volume after 7 days treatment
Note: 1. Portal vein blood flow volume will be measured by doppler ultrasound device. 2. Values are the mean of three consecutive measurements. 3. Frequency: PVF will be measured on baseline, day1, day 5 and day 7. 4. All doppler studies will be carried out by a single experienced examiner who will be blinded to patient allocation.
3 secondary outcomes
Portal vein diameter (PVD mm)
Time frame: change from baseline in PDV after 7 days treatment
Mean portal vein blood velocity (PVV cm/s)
Time frame: change from baseline in PVV after 7 days treatment
Ascites volume
Time frame: change from baseline after 7 days treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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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.
Yun Sh Yang, Pro. principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatostatin and endoscopic therapy in people with Esophageal Varices Secondary to Cirrhosis of Liver, run by Yunsheng Yang at 1 site in China.
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 3 inclusion and 15 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 2 Sep 2011. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal vein blood flow volume (time frame: change from baseline in portal vein blood flow volume after 7 days treatment). 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 2 Sep 2011.