Acute Bleeding Esophageal VaricesSOVNCT01851564
RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
A study testing Self-expanding mesh-metal oesophageal stent (SEMS) and Standard Therapy in people with Acute Bleeding Esophageal Varices, run by University College, London at 3 sites in United Kingdom.
Trial summary
The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bleeding Esophageal Varices
- What is being tested?
- Self-expanding mesh-metal oesophageal stent (SEMS) and Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2012to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm 1: Participants with Child-Pugh grade B or C cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation . The diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data.
- Arm 2: Participants with Child-Pugh grade A, B or C cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation.
Who cannot join
- < 18 Years of age
- Child-Pugh grade A cirrhosis (for Arm 1 only)
- Varices which would not be treated with band ligation as standard therapy
- Non-cirrhotic portal hypertension
- Malignancy of the oesophagus, stomach or upper respiratory tract
- Oesophageal stenosis which prohibits endoscopy
Show all 11Show fewer
- Recent oesophageal surgery
- A large hiatus hernia which prevents stent placement
- Known hepatocellular carcinoma considered to be incurable (according to Milan Criteria)
- Patients in the terminal phases of hepatological or other disease
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
United Bristol Hospitals NHS Foundation Trust
Bristol, BS2 8HW
Barts Health NHS Trust
London, E1 1BB
Royal Free London NHS Foundation Trust
London, NW3 2QG
About this study
Official title: Effective Haemostasis Using Self-expandable Covered Mesh-metal Oesophageal Stents Versus Standard Endoscopic Therapy in the Treatment of Oesophageal Variceal Haemorrhage: A Multicentre, Open, Prospective, Randomised, Controlled Study.
The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. This randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.
Read the detailed description
Despite improvements in recent years, mortality from variceal bleeding remains significant. The routine use of banding ligation, vasoactive drugs, and antibiotics has had an impact on survival rates such that survival rates of patients with Childs-Pugh A and B class cirrhosis may be as high as 90% at 30 days. However, the successful outcome of variceal bleeding is compromised in some patients because of initial failure to control bleeding or early re-bleeding, both of which have a significant impact on mortality.
The SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic) is a removable, covered, self-expanding mesh-metal stent (SEMS) that can be deployed in the lower oesophagus over an endoscopically placed guidewire without radiological screening. The stent controls bleeding by tamponade of varices in the lower oesophagus.
The series reported to date suggest that the self-expandable covered stents can provide 100% haemostasis rates when applied for refractory oesophageal variceal bleeding. Given the potentially lower risks of re-bleeding and safe, easy insertion techniques the self-expandable covered stents may offer a superior alternative to standard endoscopic therapy.
- Conditions
- Acute Bleeding Esophageal Varices
- Being tested
- Self-expanding mesh-metal oesophageal stent (SEMS), Standard Therapy
- Keywords
- Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent
- Medical subject headings
- Gastrointestinal Hemorrhage, Varicose Veins, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-expanding mesh-metal oesophageal stent (SEMS)Device
Also called DANIS Stent
A removable stent designed for the treatment of bleeding oesophageal varices.
Standard TherapyOther
Standard Medical and Endoscopic Therapy
| Study group | Role | What they receive |
|---|---|---|
| SEMS for primary variceal haemorrhage | Experimental | Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage. Receives: Device: Self-expanding mesh-metal oesophageal stent (SEMS) |
| Standard Therapy - Primary Haemorrhage | Active comparator | Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage. Receives: Other: Standard Therapy |
| SEMS for Failure to Control Bleeding | Experimental | Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage. Receives: Device: Self-expanding mesh-metal oesophageal stent (SEMS) |
| Standard Therapy - Failure of Control | Active comparator | Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage. Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure to Control Bleeding
Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.
Measured: 7 days
Secondary outcomes (9)
Absence of Bleeding at 14 and 42 days
Measured: 14 and 42 days
Participant Survival
Measured: 7, 14, 42 days and 6 months
Absence of Stent Migration
for the duration of stent migration
Measured: 7 days
Requirement for Blood products
Measured: 7 days
Requirement for Analgesia and Sedation whilst Stent in in situ
Measured: 7 days
Presence of Thoracic Pain or Dysphagia
Measured: 7 days
Length of Intensive Care Unit and Total Hospital Stay
Measured: Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
Measured: 7 days
Repeated presentation with variceal bleeding within 6 months
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 posted10 May 2013 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Bleeding Esophageal VaricesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Hampstead NHS Trust, Barts & The London NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- James O'Beirne, MBBS FRCP, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851564
- Sponsor's protocol ID
- 74570
- Other IDs
- 11/0261, 13392
- Acronym
- SOV
- Status last verified
- Jun 2015
- First submitted
- 21 Dec 2012
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carbonell N, Pauwels A, Serfaty L, Fourdan O, Levy VG, Poupon R. Improved survival after variceal bleeding in patients with cirrhosis over the past two decades. Hepatology. 2004 Sep;40(3):652-9. doi: 10.1002/hep.20339.
PubMed 15349904Burroughs AK, Triantos CK, O'Beirne J, Patch D. Predictors of early rebleeding and mortality after acute variceal hemorrhage in patients with cirrhosis. Nat Clin Pract Gastroenterol Hepatol. 2009 Feb;6(2):72-3. doi: 10.1038/ncpgasthep1336. Epub 2008 Dec 17.
PubMed 19092789Ben-Ari Z, Cardin F, McCormick AP, Wannamethee G, Burroughs AK. A predictive model for failure to control bleeding during acute variceal haemorrhage. J Hepatol. 1999 Sep;31(3):443-50. doi: 10.1016/s0168-8278(99)80035-x.
PubMed 10488702D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
PubMed 12939586de Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available.
PubMed 20638742Hubmann R, Bodlaj G, Czompo M, Benko L, Pichler P, Al-Kathib S, Kiblbock P, Shamyieh A, Biesenbach G. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy. 2006 Sep;38(9):896-901. doi: 10.1055/s-2006-944662.
PubMed 16981106Zehetner J, Shamiyeh A, Wayand W, Hubmann R. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc. 2008 Oct;22(10):2149-52. doi: 10.1007/s00464-008-0009-7. Epub 2008 Jul 12.
PubMed 18622540Wright G, Lewis H, Hogan B, Burroughs A, Patch D, O'Beirne J. A self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc. 2010 Jan;71(1):71-8. doi: 10.1016/j.gie.2009.07.028. Epub 2009 Oct 30.
PubMed 19879564Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.
PubMed 2679046Garcia-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.
PubMed 17879356
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Haemostasis Using Self-expandable Covered Mesh-metal Oesophageal Stents Versus Standard Endoscopic Therapy in the Treatment of Oesophageal Variceal Haemorrhage: A Multicentre, Open, Prospective, Randomised, Controlled Study.
- ClinicalTrials.gov ID
- NCT01851564
- Acronym / sponsor ID
- SOV / 74570
- Conditions
- Acute Bleeding Esophageal Varices
- Keywords
- Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal Free Hampstead NHS Trust, Barts & The London NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 May 2013 (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 mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. This randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.
Detailed description
Despite improvements in recent years, mortality from variceal bleeding remains significant. The routine use of banding ligation, vasoactive drugs, and antibiotics has had an impact on survival rates such that survival rates of patients with Childs-Pugh A and B class cirrhosis may be as high as 90% at 30 days. However, the successful outcome of variceal bleeding is compromised in some patients because of initial failure to control bleeding or early re-bleeding, both of which have a significant impact on mortality.
The SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic) is a removable, covered, self-expanding mesh-metal stent (SEMS) that can be deployed in the lower oesophagus over an endoscopically placed guidewire without radiological screening. The stent controls bleeding by tamponade of varices in the lower oesophagus.
The series reported to date suggest that the self-expandable covered stents can provide 100% haemostasis rates when applied for refractory oesophageal variceal bleeding. Given the potentially lower risks of re-bleeding and safe, easy insertion techniques the self-expandable covered stents may offer a superior alternative to standard endoscopic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SEMS for primary variceal haemorrhage | Experimental | Device: Self-expanding mesh-metal oesophageal stent (SEMS)Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage. |
| Standard Therapy - Primary Haemorrhage | Active comparator | Other: Standard TherapyUse of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage. |
| SEMS for Failure to Control Bleeding | Experimental | Device: Self-expanding mesh-metal oesophageal stent (SEMS)Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage. |
| Standard Therapy - Failure of Control | Active comparator | Other: Standard TherapyUse of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Arm 1: Participants with Child-Pugh grade B or C cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation . The diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data.
- Arm 2: Participants with Child-Pugh grade A, B or C cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation.
Key exclusion criteria (11 listed)
- < 18 Years of age
- Child-Pugh grade A cirrhosis (for Arm 1 only)
- Varices which would not be treated with band ligation as standard therapy
- Non-cirrhotic portal hypertension
- Malignancy of the oesophagus, stomach or upper respiratory tract
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 |
|---|---|---|
| Self-expanding mesh-metal oesophageal stent (SEMS)Also: DANIS StentA removable stent designed for the treatment of bleeding oesophageal varices. | Device | SEMS for Failure to Control Bleeding, SEMS for primary variceal haemorrhage |
| Standard TherapyStandard Medical and Endoscopic Therapy | Other | Standard Therapy - Failure of Control, Standard Therapy - Primary Haemorrhage |
Primary outcome
Failure to Control Bleeding
Time frame: 7 days
Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.
9 secondary outcomes
Absence of Bleeding at 14 and 42 days
Time frame: 14 and 42 days
Participant Survival
Time frame: 7, 14, 42 days and 6 months
Absence of Stent Migration
Time frame: 7 days
Requirement for Blood products
Time frame: 7 days
Requirement for Analgesia and Sedation whilst Stent in in situ
Time frame: 7 days
Presence of Thoracic Pain or Dysphagia
Time frame: 7 days
Length of Intensive Care Unit and Total Hospital Stay
Time frame: Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
Time frame: 7 days
Repeated presentation with variceal bleeding within 6 months
Time frame: 6 months
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 20 Sep 2016.
- Background: PubMed 15349904Carbonell N, Pauwels A, Serfaty L, Fourdan O, Levy VG, Poupon R. Improved survival after variceal bleeding in patients with cirrhosis over the past two decades. Hepatology. 2004 Sep;40(3):652-9. doi: 10.1002/hep.20339.
- Background: PubMed 19092789Burroughs AK, Triantos CK, O'Beirne J, Patch D. Predictors of early rebleeding and mortality after acute variceal hemorrhage in patients with cirrhosis. Nat Clin Pract Gastroenterol Hepatol. 2009 Feb;6(2):72-3. doi: 10.1038/ncpgasthep1336. Epub 2008 Dec 17.
- Background: PubMed 10488702Ben-Ari Z, Cardin F, McCormick AP, Wannamethee G, Burroughs AK. A predictive model for failure to control bleeding during acute variceal haemorrhage. J Hepatol. 1999 Sep;31(3):443-50. doi: 10.1016/s0168-8278(99)80035-x.
- Background: PubMed 12939586D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
- Background: PubMed 20638742de Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available.
- Background: PubMed 16981106Hubmann R, Bodlaj G, Czompo M, Benko L, Pichler P, Al-Kathib S, Kiblbock P, Shamyieh A, Biesenbach G. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy. 2006 Sep;38(9):896-901. doi: 10.1055/s-2006-944662.
- Background: PubMed 18622540Zehetner J, Shamiyeh A, Wayand W, Hubmann R. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc. 2008 Oct;22(10):2149-52. doi: 10.1007/s00464-008-0009-7. Epub 2008 Jul 12.
- Background: PubMed 19879564Wright G, Lewis H, Hogan B, Burroughs A, Patch D, O'Beirne J. A self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc. 2010 Jan;71(1):71-8. doi: 10.1016/j.gie.2009.07.028. Epub 2009 Oct 30.
- Background: PubMed 2679046Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.
- Background: PubMed 17879356Garcia-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.
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.
James O'Beirne, MBBS FRCP principal investigator
Royal Free London NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-expanding mesh-metal oesophageal stent (SEMS) and Standard Therapy in people with Acute Bleeding Esophageal Varices, run by University College, London at 3 sites in United Kingdom.
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 2 inclusion and 11 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
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?
Failure to Control Bleeding (time frame: 7 days). 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 NCT01851564, which also lists 10 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 20 Sep 2016.