Non-alcoholic Steatohepatitis (NASH)TESLA-NASHNCT04060368
Efficacy and Safety of Endoscopic Sleeve Gastroplasty Versus Laparoscopic Sleeve Gastrectomy in Obese Subjects With NASH
A study testing Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications and Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications in people with Non-alcoholic Steatohepatitis (NASH), run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
Trial summary
The primary objectives of this study are to evaluate the effect of ESG with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) compared to LSG on 1) histological improvement in NASH; 2) all-cause mortality and liver-related outcomes In obese subjects with non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis (NASH)
- What is being tested?
- Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications and Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 1 Jun 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged between 18 and 60 years (inclusive) at first screening visit.
- Must provide signed written informed consent and agree to comply with the study protocol.
- BMI between 35 and 45 kg/m2 with or without metabolic risk factors (type 2 diabetes, arterial hypertension, dyslipidaemia), and BMI between 30 and 34,9 kg/m2 with type 2 diabetes.
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and:
- NAS score ≥ 4
- fibrosis < 4 according to the staging system of CRN fibrosis on NASH
Show all 9Show fewer
- For patients with fibrosis ≤ 1, must be associated at least one of the following conditions: metabolic syndrome (NCEP ATP III definition), type 2 diabetes, HOMA-IR >6
- Absence of other well documented causes of chronic liver disease (alcoholic liver disease, viral hepatitis, cholestasis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha 1 antitrypsin deficiency)
- Patients agree to have 1 liver biopsy after 96 weeks after intervention
Who cannot join
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of efficient bariatric surgery within 10 years prior to Screening.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Recent or current background of significant consumption of alcoholic beverages (<5 years). In the case of men, significant consumption is usually defined as more than 30 g of pure alcohol per day. In the case of women, it is usually defined as more than 20 g of pure alcohol per day.
- Liver cirrhosis.
Show all 23Show fewer
- Non-cirrhotic portal hypertension.
- Esophagogastric varices.
- Hepatocellular carcinoma
- Portal thrombosis.
- Pregnancy.
- Refusal to give informed consent.
- Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- Signs of any other unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease without treatment.
- Instability or mental incompetence, so that the validity of the informed consent or the ability to comply with the study are uncertain.
- Antibodies positive for the human immunodeficiency virus.
- Descompensated liver disease with the following hematologic and biochemical criteria:
- Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (ULN)
- Total bilirubin> 25 μmol / l (1.5 mg / dl)
- Standardized international index> 1.4
- Platelet count <100 000 / mm3
- Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 1.24 mg / dl) in women.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (patients with markers of hepatic 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, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the expected randomization. An abnormal repeated eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospitl Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Paula Iruzubieta, PHD
About this study
Official title: STudy to Evaluate the Efficacy and Safety of Endoscopic Sleeve Gastroplasty (ESG) Versus LAparoscopic Sleeve Gastrectomy (LSG) in Obese Subjects With Non-Alcoholic SteatoHepatitis (NASH)
The primary objectives of this study are to evaluate the effect of ESG with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) compared to LSG on 1) histological improvement in NASH; 2) all-cause mortality and liver-related outcomes In obese subjects with non-alcoholic steatohepatitis (NASH).
Condition or disease: Non-alcoholic steatohepatitis (NASH) with or without fibrosis Intervention/treatment: ESG with OverStitch® system vs LSG
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Being tested
- Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications, Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications
- Keywords
- NASH, Obesity, Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modificationsProcedure or surgery
Endoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).
Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modificationsProcedure or surgery
Minimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature.
| Study group | Role | What they receive |
|---|---|---|
| ESG Stitch® system + Lifestyle modifications | Experimental | Endoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan). Receives: Procedure: Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications |
| LSG + Lifestyle modifications | Active comparator | Minimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature. Receives: Procedure: Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects undergoing ESG relative to LSG achieving resolution of NASH without worsening of fibrosis
To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with or without fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving NASH resolution without worsening of fibrosis. NASH resolution is defined as the disappearance of ballooning and the disappearance or persistence of minimal lobular inflammation (grade 0 or 1) The worsening of fibrosis is defined as the progression of at least one stage.
Measured: Measurement at 96 weeks
Proportion of subjects undergoing ESG relative to LSG with cardiovascular and liver-related death events
To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving improvement of liver fibrosis of at least one stage.
Measured: Measurement at 96 weeks
Secondary outcomes (27)
Proportion of subjects undergoing ESG relative to LSG achieving improvement in liver histology according to the NASH-CRN scoring
Percentage of patients with at least 1 point improvement
Measured: Measurement at 96 weeks
Changes in the liver enzymes
ALT, AST, GGT, AP (U/L)
Measured: Measurement at 96 weeks
Changes in lipid parameter
Cholesterol, LDL, HDL, Triglycerides (mg/dL)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Fatty Liver Index (FLI) (<30; 30-60; >60)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Hepatic steatosis index (HSI) (<30; 30-36; >36)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
NAFLD fibrosis score (NFS) (<-1.455; -1.455-0.676; >0.676)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
AST to Plateler ratio index (APRI) (<1, >1)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Fibrosis-4 (FIB-4) (<1.30; 1.30-2.67; >2.67)
Measured: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Hepamet fibrosis score (HFS) (<0.12; 0.12-0.47; >0.47)
Measured: Measurement at 96 weeks
Changes in body weight
body weight
Measured: Measurement at 96 weeks
Changes in inflammatory markers
Ferritin in ng/mL
Measured: Measurement at 96 weeks
Changes in inflammatory markers
C-rective protein (CRP) in mg/dL
Measured: Measurement at 96 weeks
Changes in inflammatory markers
High sensitivity C-reactive protein (hs-CRP) in mg/L
Measured: Measurement at 96 weeks
Changes in inflammatory markers
Interleukin 6 (IL-6) in pg/mL
Measured: Measurement at 96 weeks
Changes in inflammatory markers
Interleukin 1 beta (IL-1b) in pg/mL
Measured: Measurement at 96 weeks
Changes in inflammatory markers
Tumor necrosis factor alpha (TNFa) in pg/mL
Measured: Measurement at 96 weeks
Changes in serum expression of incretins
serum expression of incretins
Measured: Measurement at 96 weeks
Changes in mineral metabolism parameters.
Parathormone (PTH) (pg/mL), 25(OH)D (ng/mL), PINP, b-CTX (ng/mL)
Measured: Measurement at 96 weeks
Changes in gut microbiota
Analysis using 16S rRNA sequencing from stool samples
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Glucose in mg/dL
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Hemoglobin A1c (HbA1c) in %
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Homeostatic model assessment for insulin resistance (HOMA-IR) (not unit)
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Adponectin in ug/mL
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Retinol binding protein 4 (RBP-4) in ug/mL
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Monocyte chemoattractant protein-1 (MCP-1) in ug/mL
Measured: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Plaminogen activator inhibitor-1 (PAI-1) in ug/mL
Measured: Measurement at 96 weeks
Incidence of adverse events
Safety and tolerability
Measured: Measurement at 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Jun 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Endoscopic Sleeve Gastroplasty with OverStitch® system + Lifestyle modifications Comparator: Laparoscopic Sleeve Gastrectomy + Lifestyle modifications
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UECV, Instituto de Investigación Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060368
- Sponsor's protocol ID
- TESLA-NASH
- Acronym
- TESLA-NASH
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2019
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cuadrado A, Orive A, Garcia-Suarez C, Dominguez A, Fernandez-Escalante JC, Crespo J, Pons-Romero F. Non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma. Obes Surg. 2005 Mar;15(3):442-6. doi: 10.1381/0960892053576596.
PubMed 15826485Singh S, Allen AM, Wang Z, Prokop LJ, Murad MH, Loomba R. Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: a systematic review and meta-analysis of paired-biopsy studies. Clin Gastroenterol Hepatol. 2015 Apr;13(4):643-54.e1-9; quiz e39-40. doi: 10.1016/j.cgh.2014.04.014. Epub 2014 Apr 24.
PubMed 24768810Pais R, Charlotte F, Fedchuk L, Bedossa P, Lebray P, Poynard T, Ratziu V; LIDO Study Group. A systematic review of follow-up biopsies reveals disease progression in patients with non-alcoholic fatty liver. J Hepatol. 2013 Sep;59(3):550-6. doi: 10.1016/j.jhep.2013.04.027. Epub 2013 May 9.
PubMed 23665288Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
PubMed 21623852Machado M, Marques-Vidal P, Cortez-Pinto H. Hepatic histology in obese patients undergoing bariatric surgery. J Hepatol. 2006 Oct;45(4):600-6. doi: 10.1016/j.jhep.2006.06.013. Epub 2006 Jul 25.
PubMed 16899321Boza C, Riquelme A, Ibanez L, Duarte I, Norero E, Viviani P, Soza A, Fernandez JI, Raddatz A, Guzman S, Arrese M. Predictors of nonalcoholic steatohepatitis (NASH) in obese patients undergoing gastric bypass. Obes Surg. 2005 Sep;15(8):1148-53. doi: 10.1381/0960892055002347.
PubMed 16197788Lavin-Alconero L, Fernandez-Lanas T, Iruzubieta-Coz P, Arias-Loste MT, Rodriguez-Duque JC, Rivas C, Cagigal ML, Montalban C, Useros AL, Alvarez-Cancelo A, Garcia-Saiz M, Crespo-Garcia J. Efficacy and safety of endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy in obese subjects with Non-Alcoholic SteatoHepatitis (NASH): study protocol for a randomized controlled trial (TESLA-NASH study). Trials. 2021 Oct 30;22(1):756. doi: 10.1186/s13063-021-05695-7.
PubMed 34717726
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STudy to Evaluate the Efficacy and Safety of Endoscopic Sleeve Gastroplasty (ESG) Versus LAparoscopic Sleeve Gastrectomy (LSG) in Obese Subjects With Non-Alcoholic SteatoHepatitis (NASH)
- ClinicalTrials.gov ID
- NCT04060368
- Acronym / sponsor ID
- TESLA-NASH / TESLA-NASH
- Conditions
- Non-alcoholic Steatohepatitis (NASH)
- Keywords
- NASH, Obesity, Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 19 Aug 2019 (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.
The primary objectives of this study are to evaluate the effect of ESG with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) compared to LSG on 1) histological improvement in NASH; 2) all-cause mortality and liver-related outcomes In obese subjects with non-alcoholic steatohepatitis (NASH).
Condition or disease: Non-alcoholic steatohepatitis (NASH) with or without fibrosis Intervention/treatment: ESG with OverStitch® system vs LSG
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Endoscopic Sleeve Gastroplasty with OverStitch® system + Lifestyle modifications Comparator: Laparoscopic Sleeve Gastrectomy + Lifestyle modifications
| Arm | Type | Receives |
|---|---|---|
| ESG Stitch® system + Lifestyle modifications | Experimental | Procedure: Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modificationsEndoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan). |
| LSG + Lifestyle modifications | Active comparator | Procedure: Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modificationsMinimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects aged between 18 and 60 years (inclusive) at first screening visit.
- Must provide signed written informed consent and agree to comply with the study protocol.
- BMI between 35 and 45 kg/m2 with or without metabolic risk factors (type 2 diabetes, arterial hypertension, dyslipidaemia), and BMI between 30 and 34,9 kg/m2 with type 2 diabetes.
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and:
- For patients with fibrosis ≤ 1, must be associated at least one of the following conditions: metabolic syndrome (NCEP ATP III definition), type 2 diabetes, HOMA-IR >6
Key exclusion criteria (23 listed)
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of efficient bariatric surgery within 10 years prior to Screening.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Recent or current background of significant consumption of alcoholic beverages (<5 years). In the case of men, significant consumption is usually defined as more than 30 g of pure alcohol per day. In the case of women, it is usually defined as more than 20 g of pure alcohol per day.
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 Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modificationsEndoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan). | Procedure or surgery | ESG Stitch® system + Lifestyle modifications |
| Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modificationsMinimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature. | Procedure or surgery | LSG + Lifestyle modifications |
Primary outcome
Proportion of subjects undergoing ESG relative to LSG achieving resolution of NASH without worsening of fibrosis
Time frame: Measurement at 96 weeks
To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with or without fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving NASH resolution without worsening of fibrosis. NASH resolution is defined as the disappearance of ballooning and the disappearance or persistence of minimal lobular inflammation (grade 0 or 1) The worsening of fibrosis is defined as the progression of at least one stage.
Proportion of subjects undergoing ESG relative to LSG with cardiovascular and liver-related death events
Time frame: Measurement at 96 weeks
To evaluate the effect of ESG compared to LSG on liver histology in obese subjects with NASH with fibrosis by assessing the following endpoint: The proportion of subjects undergoing ESG relative to LSG achieving improvement of liver fibrosis of at least one stage.
27 secondary outcomes
Proportion of subjects undergoing ESG relative to LSG achieving improvement in liver histology according to the NASH-CRN scoring
Time frame: Measurement at 96 weeks
Changes in the liver enzymes
Time frame: Measurement at 96 weeks
Changes in lipid parameter
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in noninvasive markers of fibrosis and steatosis
Time frame: Measurement at 96 weeks
Changes in body weight
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in inflammatory markers
Time frame: Measurement at 96 weeks
Changes in serum expression of incretins
Time frame: Measurement at 96 weeks
Changes in mineral metabolism parameters.
Time frame: Measurement at 96 weeks
Changes in gut microbiota
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Changes in glucose homeostasis markers and insulin resistance
Time frame: Measurement at 96 weeks
Incidence of adverse events
Time frame: Measurement at 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Results publication: PubMed 15826485Cuadrado A, Orive A, Garcia-Suarez C, Dominguez A, Fernandez-Escalante JC, Crespo J, Pons-Romero F. Non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma. Obes Surg. 2005 Mar;15(3):442-6. doi: 10.1381/0960892053576596.
- Results publication: PubMed 24768810Singh S, Allen AM, Wang Z, Prokop LJ, Murad MH, Loomba R. Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: a systematic review and meta-analysis of paired-biopsy studies. Clin Gastroenterol Hepatol. 2015 Apr;13(4):643-54.e1-9; quiz e39-40. doi: 10.1016/j.cgh.2014.04.014. Epub 2014 Apr 24.
- Results publication: PubMed 23665288Pais R, Charlotte F, Fedchuk L, Bedossa P, Lebray P, Poynard T, Ratziu V; LIDO Study Group. A systematic review of follow-up biopsies reveals disease progression in patients with non-alcoholic fatty liver. J Hepatol. 2013 Sep;59(3):550-6. doi: 10.1016/j.jhep.2013.04.027. Epub 2013 May 9.
- Results publication: PubMed 21623852Vernon G, Baranova A, Younossi ZM. Systematic review: the epidemiology and natural history of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in adults. Aliment Pharmacol Ther. 2011 Aug;34(3):274-85. doi: 10.1111/j.1365-2036.2011.04724.x. Epub 2011 May 30.
- Results publication: PubMed 16899321Machado M, Marques-Vidal P, Cortez-Pinto H. Hepatic histology in obese patients undergoing bariatric surgery. J Hepatol. 2006 Oct;45(4):600-6. doi: 10.1016/j.jhep.2006.06.013. Epub 2006 Jul 25.
- Results publication: PubMed 16197788Boza C, Riquelme A, Ibanez L, Duarte I, Norero E, Viviani P, Soza A, Fernandez JI, Raddatz A, Guzman S, Arrese M. Predictors of nonalcoholic steatohepatitis (NASH) in obese patients undergoing gastric bypass. Obes Surg. 2005 Sep;15(8):1148-53. doi: 10.1381/0960892055002347.
- Derived from this study: PubMed 34717726Lavin-Alconero L, Fernandez-Lanas T, Iruzubieta-Coz P, Arias-Loste MT, Rodriguez-Duque JC, Rivas C, Cagigal ML, Montalban C, Useros AL, Alvarez-Cancelo A, Garcia-Saiz M, Crespo-Garcia J. Efficacy and safety of endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy in obese subjects with Non-Alcoholic SteatoHepatitis (NASH): study protocol for a randomized controlled trial (TESLA-NASH study). Trials. 2021 Oct 30;22(1):756. doi: 10.1186/s13063-021-05695-7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications and Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications in people with Non-alcoholic Steatohepatitis (NASH), run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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 9 inclusion and 23 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 30 Sep 2020. 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 Spain. 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?
Contact Javier Crespo, PROF (+34942204089, javier.crespo@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects undergoing ESG relative to LSG achieving resolution of NASH without worsening of fibrosis (time frame: Measurement at 96 weeks). The study lists 2 primary outcomes in all. 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 NCT04060368, which also lists 7 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 30 Sep 2020.