Portal Hypetension and Bariatric Surgery (BARIAPORTAL)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bariatric surgery Individuals with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery |
Procedure: Bariatric surgery
Bariatric surgery
|
Outcome Measures
Primary Outcome Measures
- Postoperative mortality [Within 90 of surgery or any tipe during postoperative hospital stay]
number of patients who died after the surgery
Secondary Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de NICE | Nice | France | 06200 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22Chirdig01