Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

Completed

• Conditions: Portal Hypertension; Obesity, Morbid; Bariatric Surgery Candidate
• Interventions: Procedure: Bariatric surgery

• Registration Number: NCT05653115
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-12
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bariatric surgery	Bariatric surgery	Individuals with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery

Primary Outcome Measures

Name	Time	Method
Postoperative mortality	Within 90 of surgery or any tipe during postoperative hospital stay	number of patients who died after the surgery

Secondary Outcome Measures

Name	Time	Method
General information and anthropometrics	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).
Etiology of liver cirrhosis	through study completion on average 1 year	viral (HCV, HBV), NASH, Alcohol, other
Preoperative work-up to define CSPH	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).
Liver function	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)
Strategy to lower portal hypertension	through study completion on average 1 year	TIPS, Beta blockers
Type of bariatric procedure	through study completion on average 1 year	SG, RYGB, Band, other
Postoperative complications	through study completion on average 1 year	bleeding, leak, pulmonary embolus, stricture, other
Functional results	through study completion on average 1 year	weight loss in Kg as compared to preoperative weight

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France