Endoscopic Bariatric Therapy in NASH Cirrhosis
ETHIC
Proof-of-concept Study of the Use of Endoscopic Gastroplasty in Patients With Obesity and Non-alcoholic Steatohepatitis Compensated Liver Cirrhosis (NASH)
1 other identifier
observational
10
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 24, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 25, 2020
February 1, 2020
1 year
February 20, 2020
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Number of adverse events resulting from the procedure during the study
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
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.
96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Death from all causes
96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Liver transplant
96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Model for end-stage liver disease (MELD) ≥ 15.
96 weeks
To evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Worsening of the Child-Pugh score by at least 2 points
96 weeks
Number of the patients to evaluate the safety of endoscopic vertical gastroplasty + lifestyle modification
Appearance of hepatocellular carcinoma (HCC)
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
96 weeks
Secondary Outcomes (5)
Evaluate the following histological changes of treatment according to NASH-CRN criteria
after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
after 96 weeks
Reduction the following histological changes of treatment according to NASH-CRN criteria
after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
after 96 weeks
Evaluate the following histological changes of treatment according to NASH-CRN criteria
after 96 weeks
Study Arms (1)
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
Interventions
endoscopic vertical gastroplasty + lifestyle modification
Eligibility Criteria
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.
You may qualify if:
- \) 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.
- \) Subjects with a BMI greater than 30 kg/m2 whether or not associated with metabolic risk factors (MD, hypertension, dyslipemia).
- \) 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.
- \) Absence of other causes of chronic liver disease (alcoholic, viral, autoimmune, cholestatic disease, Wilson's disease, α1AT deficit, hemochromatosis)
You may not qualify if:
- 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.
- 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.
- \) Pregnancy. 15) Refusal to give informed consent. 16) Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- \) Indications of any other untreated, unstable or clinically significant immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
- \) Mental instability or incompetence such that the validity of the informed consent or the ability to comply with the study is uncertain.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 24, 2020
Study Start
April 1, 2020
Primary Completion
April 1, 2021
Study Completion
April 1, 2022
Last Updated
February 25, 2020
Record last verified: 2020-02