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NCT Number: NCT05653115

Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

The worldwide obesity epidemic has led to an increase in the proportion of patients with chronic liver disease due to non-alcoholic fatty liver disease (NAFLD) and in the prevalence of obesity in patients with cirrhosis of all etiologies. The reported prevalence of obesity in patients with cirrhosis is of 30% which appears similar to that of the general population.

Bariatric surgery is currently considered as the most effective and durable means for the management of morbid obesity as it is associated with the remission and/or improvement of many obesity associated comorbidities as well as improved quality and expectancy of life.

However, the surgical risk is increased compared to individuals without cirrhosis, and determining the risk/benefit ratio of bariatric surgery in the setting of cirrhosis is a complex task further hampered by the lack of randomized controlled trials.

The Nationwide Inpatient Sample study reported a slightly increased rate of mortality of bariatric surgery in the setting of compensated cirrhosis compared to individuals without cirrhosis (0.9% vs 0.3%). Interestingly, this risk was as high as 16.3% in individuals with decompensated cirrhosis (16.3%). However, this study has been published more than 10 years ago and the mortality of bariatric surgery has decreased significantly and is around 0.1%. Furthermore, the introduction of transient elastography in clinical practice has allowed the early identification of patients with chronic liver disease (CLD) at risk of developing clinically significant portal hypertension (CSPH).

A few series including a limited number of patients have been published indicating that CSPH should not be considered as a formal contraindication for bariatric surgery.

This study is meant to assess the outcomes of bariatric surgery in patients with morbid obesity and compensated advanced chronic liver disease (cACLD) (currently synonymous of the term "compensated cirrhosis'') associated with clinically significant portal hypertension (CSPH) in a large multicentric, multinational series.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Digestive System Diseases Hypertension, Portal Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Portal Hypertension Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE

Nice, 06200, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with morbid obesity (BMI > 40 or 35 with at least one comorbidity) undergoing bariatric surgery and CSPH (defined as HVPG > 10 mmHg and/or cross-sectional imaging showing collateral circulation, and/or varices at esophagogastroduodenoscopy.
  • Information available to determine postoperative mortality (at least first postoperative month of any duration in case of primary hospitalization longer than 1 month)

Exclusion criteria

  • Absence of preoperative evidence of CSPH in spite of evidence liver cirrhosis.
  • Absence of information to determine at least postoperative mortality.

Treatment and study plan

bariatric surgery

Procedure

Bariatric surgery

Primary outcomes

  1. Postoperative mortality

    Time frame: Within 90 of surgery or any tipe during postoperative hospital stay

    number of patients who died after the surgery

Secondary outcomes

  1. General information and anthropometrics

    Time frame: through study completion on average 1 year

    Age (years), gender (male/ female), body weight (Kg), height (meters), BMI (body weight in Kg/height in meters); obesity linked comorbid conditions : hypertension (HT is defined as resting blood pressure persistently ≥ 140/90 mmHg or need for antihypertensive drugs), Type 2 diabetes (T2D is defined as fasting glucose > 7.0 mmol/L after two measurements or need for oral antidiabetics), sleep apnea syndrome (SAS is quantified by sleep studies).

  2. Etiology of liver cirrhosis

    Time frame: through study completion on average 1 year

    viral (HCV, HBV), NASH, Alcohol, other

  3. Preoperative work-up to define CSPH

    Time frame: through study completion on average 1 year

    endoscopy (presence of varices), imaging CT scan (presence of porto-systemic shunts), MRI (presence of porto-systemic shunts), portal pressure measure (mmHg).

  4. Liver function

    Time frame: through study completion on average 1 year

    Child's score (Child A 5-6 points; Child B 7-9; Child C 10-15), Model for End-Stage Liver Disease (MELD) score (number of points up to 40)

  5. Strategy to lower portal hypertension

    Time frame: through study completion on average 1 year

    TIPS, Beta blockers

  6. Type of bariatric procedure

    Time frame: through study completion on average 1 year

    SG, RYGB, Band, other

  7. Postoperative complications

    Time frame: through study completion on average 1 year

    bleeding, leak, pulmonary embolus, stricture, other

  8. Functional results

    Time frame: through study completion on average 1 year

    weight loss in Kg as compared to preoperative weight

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Outcomes of Bariatric Surgery in the Setting of Compensated Advance+B9d Chronic Liver Disease Associated With Clinically Significant Portal Hypertension

Acronym: BARIAPORTAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2022
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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