NCT05653115: BARIAPORTAL

Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

Completed Last updated 10 April 2025

What this trial tests

trial testing Bariatric surgery in Bariatric Surgery Candidate in 63 participants. Completed in 31 October 2022.

Timeline

12 January 2022

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Status	Completed
Study type	OBSERVATIONAL
Enrollment	63
Start date	12 January 2022
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across France

Drugs / interventions tested

• Bariatric surgery

Conditions studied

• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →
• Obesity, Morbid — all drugs for Obesity, Morbid →
• Portal Hypertension — all drugs for Portal Hypertension →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

Adults 18 to 65, any sex, with Bariatric Surgery Candidate or Obesity, Morbid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.