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Embolization of Arterial Gastric Supply in Obesity (Embargo)

Primary Purpose

Morbid Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emblization of the gastro-epiploic arcade
Sponsored by
IHU Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Bariatric embolization, Obesity, Metabolic syndrome

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient aged ≥18 and ≤ 71 years old
  • BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea
  • Relative contraindication to bariatric surgery
  • Able to sign informed consent.

Exclusion Criteria:

General

  • Impossible or unwilling to attend follow-up visits.
  • Weight > 250kg (weight limit of angiography table)
  • Confirmed allergy to intravenous contrast agents.
  • Pregnancy, breast feeding or willingness to conceive during the following year
  • Impossible to maintain dorsal decubitus during intervention
  • Life expectancy < 1 year
  • Current enrollment in another clinical trial
  • Arterial anatomy rendering embolization very difficult or impossible (as evaluated by investigators)
  • Patient under the protection of justice
  • Patient under guardianship or trusteeship

Gastro-intestinal

  • Pre-existing chronic abdominal pain
  • History of inflammatory bowel disease
  • History of gastroparesis
  • History of gastric surgery, gastric embolization or radiotherapy
  • History of peptic ulcer
  • Significant risk factors for peptic ulcer, including daily use of non-steroidal anti-inflammatory drugs, active smoking or active infection with Helicobacter pylori
  • Abnormal upper digestive endoscopy

Hepatic

  • Cirrhosis
  • Portal venous hypertension
  • Bilirubin > 2,0 mg/dL
  • Albumin < 2,5 g/L

Cardiovascular

  • Known aortic pathology i.e. aneurysm or dissection
  • Severe peripheral arterial disease

Renal

- Renal failure, Creatinine Clearance < 60ml/min/1,73 m2

Hematologic/Immunologic/Oncologic/Infectious

  • Acute or chronic infection
  • Active cancer
  • Auto-immune disease requiring immunosuppression
  • Neutrophil count < 1,5 x 10 ^ 9/L
  • Platelet count < 100 x 10 ^ 9/L

Contraindication to contrast medium Visipaque solution for injection

  • Hypersensitivity to the active substance (Iodixanol) or to any of the excipients
  • History of immediate major or delayed skin reaction to the injection of the product
  • Decompensated heart failure
  • Thyrotoxicosis
  • Contraindication to the use of the embogold microsphere

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Embolization

    Arm Description

    Patients undergoing embolization of the gastro-epiploic arcade

    Outcomes

    Primary Outcome Measures

    Number of participants with adverse events
    Number of participants with adverse events
    Number of participants with adverse events
    Number of participants with adverse events
    Number of participants with adverse events

    Secondary Outcome Measures

    Change in weight
    Weight loss expressed in percentage of total weight loss (%TWL)
    Change in abdominal circumference
    Measurement of abdominal circumference in centimetres
    Change in thigh circumferences
    Measurement of thigh circumferences in centimetres
    Change in Ghrelinemia
    Measurement of serum ghrelin concentration
    Change in Quality of life
    Quality of Life is scored using Moorehead-Ardelt II Quality of life questionnaire. The questionnaire involves 6 questions scored from -0,5 to +0,5. The mean of the 6 answers leads to a sum between -3 (very poor quality of life) to +3 (very good quality of life).
    Number of upper digestive endoscopies
    Count of upper digestive endoscopies performed per patient during the study period

    Full Information

    First Posted
    December 16, 2019
    Last Updated
    March 28, 2022
    Sponsor
    IHU Strasbourg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04207424
    Brief Title
    Embolization of Arterial Gastric Supply in Obesity
    Acronym
    Embargo
    Official Title
    EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Patients were selected but their very condition and the resulting comorbidities did not allow their inclusion. In addition, the health crisis prevented any bariatric operation of this complexity for an indefinite period.
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    IHU Strasbourg

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
    Detailed Description
    Obesity is now an epidemic in the developed and developing world. Medical management is ineffective at population level. Metabolic surgery has been shown to be effective in achieving weight loss and controlling associated conditions. However, surgery is invasive and has associated complications. Furthermore, not every patient is interested in or eligible for surgery. Bariatric gastric embolization recently emerged as a promising minimally invasive alternative to open bariatric surgery. Data from several initial pilot clinical trials suggests that gastric embolization is safe and can induce weight loss. Previous studies have concentrated on left gastric artery embolization as the primary target vessel because it supplies the largest portion of the fundus. However, it may be desirable to target a different artery, specifically the left gastroepiploic which also supplies the fundus. The left gastric artery is spared in bariatric surgery because it supplies the residual pouch after the surgery. Embolization of the left gastric artery may result in worse healing in the event of follow-up surgery potentially excluding people should they subsequently want it or become eligible. This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity. The target population consists of adult, morbidly obese patients with contraindication for bariatric surgery. Patients included in the study will be followed up for 12 months post bariatric embolization. The primary end point is procedural safety, defined as number and severity of adverse events occurring during the study period. Secondary end points include weight loss, evolution of weight and thigh circumferences, evolution of serum ghrelin levels and evolution of quality of life indexes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    Bariatric embolization, Obesity, Metabolic syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Embolization
    Arm Type
    Experimental
    Arm Description
    Patients undergoing embolization of the gastro-epiploic arcade
    Intervention Type
    Procedure
    Intervention Name(s)
    Emblization of the gastro-epiploic arcade
    Intervention Description
    Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles
    Primary Outcome Measure Information:
    Title
    Number of participants with adverse events
    Time Frame
    7 days post embolization
    Title
    Number of participants with adverse events
    Time Frame
    1 month post embolization
    Title
    Number of participants with adverse events
    Time Frame
    3 months post embolization
    Title
    Number of participants with adverse events
    Time Frame
    6 months post embolization
    Title
    Number of participants with adverse events
    Time Frame
    12 months post embolization
    Secondary Outcome Measure Information:
    Title
    Change in weight
    Description
    Weight loss expressed in percentage of total weight loss (%TWL)
    Time Frame
    Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
    Title
    Change in abdominal circumference
    Description
    Measurement of abdominal circumference in centimetres
    Time Frame
    Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
    Title
    Change in thigh circumferences
    Description
    Measurement of thigh circumferences in centimetres
    Time Frame
    Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
    Title
    Change in Ghrelinemia
    Description
    Measurement of serum ghrelin concentration
    Time Frame
    Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
    Title
    Change in Quality of life
    Description
    Quality of Life is scored using Moorehead-Ardelt II Quality of life questionnaire. The questionnaire involves 6 questions scored from -0,5 to +0,5. The mean of the 6 answers leads to a sum between -3 (very poor quality of life) to +3 (very good quality of life).
    Time Frame
    Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
    Title
    Number of upper digestive endoscopies
    Description
    Count of upper digestive endoscopies performed per patient during the study period
    Time Frame
    12 months after bariatric embolization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patient aged ≥18 and ≤ 71 years old BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea Relative contraindication to bariatric surgery Able to sign informed consent. Exclusion Criteria: General Impossible or unwilling to attend follow-up visits. Weight > 250kg (weight limit of angiography table) Confirmed allergy to intravenous contrast agents. Pregnancy, breast feeding or willingness to conceive during the following year Impossible to maintain dorsal decubitus during intervention Life expectancy < 1 year Current enrollment in another clinical trial Arterial anatomy rendering embolization very difficult or impossible (as evaluated by investigators) Patient under the protection of justice Patient under guardianship or trusteeship Gastro-intestinal Pre-existing chronic abdominal pain History of inflammatory bowel disease History of gastroparesis History of gastric surgery, gastric embolization or radiotherapy History of peptic ulcer Significant risk factors for peptic ulcer, including daily use of non-steroidal anti-inflammatory drugs, active smoking or active infection with Helicobacter pylori Abnormal upper digestive endoscopy Hepatic Cirrhosis Portal venous hypertension Bilirubin > 2,0 mg/dL Albumin < 2,5 g/L Cardiovascular Known aortic pathology i.e. aneurysm or dissection Severe peripheral arterial disease Renal - Renal failure, Creatinine Clearance < 60ml/min/1,73 m2 Hematologic/Immunologic/Oncologic/Infectious Acute or chronic infection Active cancer Auto-immune disease requiring immunosuppression Neutrophil count < 1,5 x 10 ^ 9/L Platelet count < 100 x 10 ^ 9/L Contraindication to contrast medium Visipaque solution for injection Hypersensitivity to the active substance (Iodixanol) or to any of the excipients History of immediate major or delayed skin reaction to the injection of the product Decompensated heart failure Thyrotoxicosis Contraindication to the use of the embogold microsphere
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raoul POP, MD, PhD
    Organizational Affiliation
    Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Links:
    URL
    https://www.cdc.gov/obesity/data/adult.html
    Description
    Centers for Disease Control and Prevention. Adult obesity facts.

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    Embolization of Arterial Gastric Supply in Obesity

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