Non-alcoholic Steatohepatitis (NASH)ETHICNCT04281303
Endoscopic Bariatric Therapy in NASH Cirrhosis
An observational study of Non-alcoholic Steatohepatitis (NASH), run by Instituto de Investigación Marqués de Valdecilla.
Trial summary
Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- Endoscopic vertical gastroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Apr 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Given the lack of previous studies on the efficacy of this technique in this type of patient, this proof-of-concept study will include a relatively small number of patients in order to obtain safety data and preliminary estimates of efficacy. Patients must present with obesity (BMI ≥ 30) associated or not with a metabolic syndrome according to NCEP ATP III criteria, which is already an indication for endoscopic treatment, and the diagnosis of cirrhosis by NASH according to histology (See inclusion criteria), which is a relative contraindication for the performance of bariatric surgery.
Who may be able to join
- 1) Subjects between the ages of 18 and 65 (inclusive) at the time of the first selection visit 2) They must provide a signed written informed consent and agree to comply with the study protocol.
- 3) Subjects with a BMI greater than 30 kg/m2 whether or not associated with metabolic risk factors (MD, hypertension, dyslipemia).
- 4) Confirmed diagnosis of non-alcoholic steatohepatitis with a degree of fibrosis 4 according to the NASH CRN staging system in a liver biopsy obtained in the 12 months prior to the endoscopic procedure or during the screening period.
- 5) Absence of other causes of chronic liver disease (alcoholic, viral, autoimmune, cholestatic disease, Wilson's disease, α1AT deficit, hemochromatosis)
Who cannot join
- Current or past history of any liver decompensation event (ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome).
- Child-Pugh Scale ≥ 7 points.
- MELD scale > 12
- Documented presence of varicose veins based on a previous endoscopy performed in the 6 months prior to the intervention.
- Documented presence of collateral circulation based on an echoendoscopy and/or thoraco-abdominal CT with 3D reconstruction performed in the selection period.
- Presence of a hepatic venous pressure gradient (HVPG) ≥ 10 mmHg in a hemodynamic study performed in the 4 months prior to surgery or in the selection period.
Show all 21Show fewer
- Known heart failure (Grade I-IV of the New York Heart Association classification).
- History of bariatric surgery
- Patients with a history of clinically significant cardiovascular events in the 6 months prior to the endoscopic procedure, such as an acute cardiovascular event, stroke, transient ischemic attack, or coronary heart disease (angina, myocardial infarction, revascularization procedures).
- Weight loss of more than 5 % in the 6 months prior to the operation.
- Recent or current history of significant consumption of alcoholic beverages (< 5 years) For men, significant consumption is usually defined as more than 30 g of pure alcohol per day. For women, it is normally defined as more than 20 g of pure alcohol per day.
- Hepatocarcinoma. (13) Portal thrombosis.
- 14) Pregnancy. 15) Refusal to give informed consent. 16) Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- 17) Indications of any other untreated, unstable or clinically significant immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
- 18) Mental instability or incompetence such that the validity of the informed consent or the ability to comply with the study is uncertain.
- 19) Positive antibodies to human immunodeficiency virus. 20) Data on decompensated liver disease:
- Aspartate aminotransferase (AST) and/or ALT > 10 x upper limit of normality (LSN)
- Total bilirubin > 2 mg/dL
- International Normalized Ratio (INR) > 1,4
- Platelet count ≤ 100 000/mm3.
- Albumin < 3.5 g/dL. 21) Serum creatinine levels > 135 μmol/l (> 1.53 mg/dl) in men and > 110 μmol/l (> 1.24 mg/dl) in women 22) Significant renal disease, including nephrotic syndrome, chronic renal disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml/min/1.73 m2). If an abnormal value is obtained at the first screening visit, eGFR measurement may be repeated before randomisation within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the intended randomisation. Repeated abnormal eGFR (less than 60 ml/min/1,73 m2 ) leads to exclusion from the study.
Trial locations and contacts
No sites are listed yet.
Lucia Lavín Alconero, MBs, PhD contact
About this study
Official title: Proof-of-concept Study of the Use of Endoscopic Gastroplasty in Patients With Obesity and Non-alcoholic Steatohepatitis Compensated Liver Cirrhosis (NASH)
Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. The standard treatment is weight loss with diet and physical exercise, which has shown a histological and analytical improvement in patients who achieve a 5-10% reduction in body weight. However, less than 25% of subjects achieve this goal. Restrictive surgical treatments and gastric bypass have achieved, in obese patients, an improvement in metabolic syndrome, insulin resistance and liver histology, but in patients with liver cirrhosis the morbidity-mortality of this surgery is high. Currently, endoscopic techniques are being developed, which are less invasive and have fewer complications, and which also achieve gastric restriction with similar characteristics to those obtained by the surgical method. Among them is the tubulization or vertical gastroplasty with the OverStitch system (Apollo Endosurgery, Austin, TX, USA). However, this method has not been evaluated in patients with obesity and/or metabolic syndrome and NASH cirrhosis. For this reason, the main objective of the investigators study is to evaluate the safety and efficacy of endoscopic gastroplasty in improving metabolic factors and liver histology in patients with obesity with or without metabolic syndrome and NASH-compensated cirrhosis.
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- Endoscopic vertical gastroplasty
- Keywords
- NASH, Obesity, endoscopic vertical gastroplasty, cirrhosis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic vertical gastroplastyProcedure or surgery
endoscopic vertical gastroplasty + lifestyle modification
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic vertical gastroplasty | Proof-of-concept study that will prospectively include a number of patients undergoing endoscopic vertical gastroplasty + lifestyle modifications to evaluate the effect of this technique in an adult population with obesity and NASH cirrhosis Receives: Procedure: Endoscopic vertical gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of adverse events resulting from the procedure during the study
Measured: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of events related to liver disease: ascites, bleeding secondary to PTH, encephalopathy, SBP, or renal failure
Measured: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of cardiovascular events during follow-up: Ischemic heart disease, stroke, peripheral arterial disease, heart failure, cardiomyopathy.
Measured: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Death from all causes
Measured: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Liver transplant
Measured: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Model for end-stage liver disease (MELD) ≥ 15.
Measured: 96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Worsening of the Child-Pugh score by at least 2 points
Measured: 96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Appearance of hepatocellular carcinoma (HCC)
Measured: 96 weeks
To evaluate the efficacy of endoscopic vertical gastroplasty + lifestyle modification in the histological improvement of fibrosis
using the percentage of subjects with improvement in at least 1 stage in fibrosis without worsening of NASH
Measured: 96 weeks
Secondary outcomes (5)
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Changes in fibrosis including: improvement, not worsening, and progression
Measured: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Resolution of NASH defined as the presence or not of steatosis, without ballooning and with no or minimal inflammation.
Measured: after 96 weeks
Reduction the following histological changes of treatment according to NASH-CRN criteria
Improvement of at least 1 point in the different components of the NASH-CRN score (steatosis, liver ballooning, and lobular inflammation)
Measured: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Improvement of fibrosis in at least 1 stage along with NASH improvement, defined as at least 1 stage improvement in fibrosis and at least 2 points less in NAFLD activity score (NAS) with at least 1 point improvement in ballooning and lobular swelling.
Measured: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
NAS score changes.
Measured: after 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Steatohepatitis (NASH)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281303
- Sponsor's protocol ID
- ETHIC
- Acronym
- ETHIC
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study of the Use of Endoscopic Gastroplasty in Patients With Obesity and Non-alcoholic Steatohepatitis Compensated Liver Cirrhosis (NASH)
- ClinicalTrials.gov ID
- NCT04281303
- Acronym / sponsor ID
- ETHIC / ETHIC
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Keywords
- NASH, Obesity, endoscopic vertical gastroplasty, cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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.
Non-alcoholic steatohepatitis (NASH) is a growing public health problem that affects more than 5% of the population and can lead to cirrhosis and hepatocellular carcinoma. These patients are at greater risk of cardiovascular and hepatic death, and higher rates of neoplasms, both gastrointestinal and extra-intestinal. The standard treatment is weight loss with diet and physical exercise, which has shown a histological and analytical improvement in patients who achieve a 5-10% reduction in body weight. However, less than 25% of subjects achieve this goal. Restrictive surgical treatments and gastric bypass have achieved, in obese patients, an improvement in metabolic syndrome, insulin resistance and liver histology, but in patients with liver cirrhosis the morbidity-mortality of this surgery is high. Currently, endoscopic techniques are being developed, which are less invasive and have fewer complications, and which also achieve gastric restriction with similar characteristics to those obtained by the surgical method. Among them is the tubulization or vertical gastroplasty with the OverStitch system (Apollo Endosurgery, Austin, TX, USA). However, this method has not been evaluated in patients with obesity and/or metabolic syndrome and NASH cirrhosis. For this reason, the main objective of the investigators study is to evaluate the safety and efficacy of endoscopic gastroplasty in improving metabolic factors and liver histology in patients with obesity with or without metabolic syndrome and NASH-compensated cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic vertical gastroplasty | – | Procedure: Endoscopic vertical gastroplastyProof-of-concept study that will prospectively include a number of patients undergoing endoscopic vertical gastroplasty + lifestyle modifications to evaluate the effect of this technique in an adult population with obesity and NASH cirrhosis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given the lack of previous studies on the efficacy of this technique in this type of patient, this proof-of-concept study will include a relatively small number of patients in order to obtain safety data and preliminary estimates of efficacy. Patients must present with obesity (BMI ≥ 30) associated or not with a metabolic syndrome according to NCEP ATP III criteria, which is already an indication for endoscopic treatment, and the diagnosis of cirrhosis by NASH according to histology (See inclusion criteria), which is a relative contraindication for the performance of bariatric surgery.
Key inclusion criteria (4 listed)
- 1) Subjects between the ages of 18 and 65 (inclusive) at the time of the first selection visit 2) They must provide a signed written informed consent and agree to comply with the study protocol.
- 3) Subjects with a BMI greater than 30 kg/m2 whether or not associated with metabolic risk factors (MD, hypertension, dyslipemia).
- 4) Confirmed diagnosis of non-alcoholic steatohepatitis with a degree of fibrosis 4 according to the NASH CRN staging system in a liver biopsy obtained in the 12 months prior to the endoscopic procedure or during the screening period.
- 5) Absence of other causes of chronic liver disease (alcoholic, viral, autoimmune, cholestatic disease, Wilson's disease, α1AT deficit, hemochromatosis)
Key exclusion criteria (21 listed)
- Current or past history of any liver decompensation event (ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome).
- Child-Pugh Scale ≥ 7 points.
- MELD scale > 12
- Documented presence of varicose veins based on a previous endoscopy performed in the 6 months prior to the intervention.
- Documented presence of collateral circulation based on an echoendoscopy and/or thoraco-abdominal CT with 3D reconstruction performed in the selection period.
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 |
|---|---|---|
| Endoscopic vertical gastroplastyendoscopic vertical gastroplasty + lifestyle modification | Procedure or surgery | Endoscopic vertical gastroplasty |
Primary outcome
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Number of adverse events resulting from the procedure during the study
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Number of events related to liver disease: ascites, bleeding secondary to PTH, encephalopathy, SBP, or renal failure
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Number of cardiovascular events during follow-up: Ischemic heart disease, stroke, peripheral arterial disease, heart failure, cardiomyopathy.
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Death from all causes
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Liver transplant
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Model for end-stage liver disease (MELD) ≥ 15.
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Worsening of the Child-Pugh score by at least 2 points
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Time frame: 96 weeks
Appearance of hepatocellular carcinoma (HCC)
To evaluate the efficacy of endoscopic vertical gastroplasty + lifestyle modification in the histological improvement of fibrosis
Time frame: 96 weeks
using the percentage of subjects with improvement in at least 1 stage in fibrosis without worsening of NASH
5 secondary outcomes
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Time frame: after 96 weeks
Reduction the following histological changes of treatment according to NASH-CRN criteria
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Time frame: after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
Time frame: after 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
Lucia Lavín Alconero, MBs, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Steatohepatitis (NASH), run by Instituto de Investigación Marqués de Valdecilla.
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 4 inclusion and 21 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 25 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula Iruzubieta, MD, PhD (942204084, p.iruzubieta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification (time frame: 96 weeks). The study lists 9 primary outcomes in all. 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 25 Feb 2020.