Clinical trial NCT05653115: Portal Hypetension and Bariatric Surgery (BARIAPORTAL)
Official title: Outcomes of Bariatric Surgery in the Setting of Compensated Advance+B9d Chronic Liver Disease Associated With Clinically Significant Portal Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Obesity, Morbid
Portal Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative mortality
timeFrame: Within 90 of surgery or any tipe during postoperative hospital stay
Secondary outcomes:
measure: General information and anthropometrics
timeFrame: through study completion on average 1 year
measure: Etiology of liver cirrhosis
timeFrame: through study completion on average 1 year
measure: Preoperative work-up to define CSPH
timeFrame: through study completion on average 1 year
measure: Liver function
timeFrame: through study completion on average 1 year
measure: Strategy to lower portal hypertension
timeFrame: through study completion on average 1 year
measure: Type of bariatric procedure
timeFrame: through study completion on average 1 year
measure: Postoperative complications
timeFrame: through study completion on average 1 year
measure: Functional results
timeFrame: through study completion on average 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
Study officials:
References:
citation: Temime V, Ghanem OM, Heimbach JK, Diwan TS, Tranchart H, Abdallah H, Blanchard C, Lontrichard M, Reche F, Borel AL, Belluzzi A, Foletto M, Manno E, Poghosyan T, Chierici A, Iannelli A. Outcomes of bariatric surgery in the setting of compensated advanced chronic liver disease associated with clinically significant portal hypertension: a multicenter, retrospective, cohort study on feasibility and safety. Int J Surg. 2024 Jun 1;110(6):3562-3570. doi: 10.1097/JS9.0000000000001310.