Embolization of Arterial Gastric Supply in Obesity (Embargo)

March 28, 2022 updated by: IHU Strasbourg

EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Embolization
Patients undergoing embolization of the gastro-epiploic arcade
Procedure: Emblization of the gastro-epiploic arcade
Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 7 days post embolization
7 days post embolization
Number of participants with adverse events
Time Frame: 1 month post embolization
1 month post embolization
Number of participants with adverse events
Time Frame: 3 months post embolization
3 months post embolization
Number of participants with adverse events
Time Frame: 6 months post embolization
6 months post embolization
Number of participants with adverse events
Time Frame: 12 months post embolization
12 months post embolization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Weight loss expressed in percentage of total weight loss (%TWL)
Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Change in abdominal circumference
Time Frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Measurement of abdominal circumference in centimetres
Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in thigh circumferences
Time Frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Measurement of thigh circumferences in centimetres
Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Ghrelinemia
Time Frame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Measurement of serum ghrelin concentration
Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Change in Quality of life
Time Frame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
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).
Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
Number of upper digestive endoscopies
Time Frame: 12 months after bariatric embolization
Count of upper digestive endoscopies performed per patient during the study period
12 months after bariatric embolization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHU Strasbourg

Investigators

  • Principal Investigator: Raoul POP, MD, PhD, Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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