Portal Hypetension and Bariatric Surgery (BARIAPORTAL) (BARIAPORTAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Portal Hypertension
• Intervention / Treatment: Procedure: Bariatric surgery

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Antonio IANNELLI; Phone Number: +33492036376; Email: iannelli.a@chu-nice.fr

Study Locations

• France
  • Nice, France, 06200
    • Recruiting
    • CHU de Nice
    • Contact: Antonio IANNELLI; Email: iannelli.a@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bariatric surgery; Individuals with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery	Procedure: Bariatric surgery; Bariatric surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality	number of patients who died after the surgery	Within 90 of surgery or any tipe during postoperative hospital stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General information and anthropometrics	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).	through study completion on average 1 year
Etiology of liver cirrhosis	viral (HCV, HBV), NASH, Alcohol, other	through study completion on average 1 year
Preoperative work-up to define CSPH	endoscopy (presence of varices), imaging CT scan (presence of porto-systemic shunts), MRI (presence of porto-systemic shunts), portal pressure measure (mmHg).	through study completion on average 1 year
Liver function	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)	through study completion on average 1 year
Strategy to lower portal hypertension	TIPS, Beta blockers	through study completion on average 1 year
Type of bariatric procedure	SG, RYGB, Band, other	through study completion on average 1 year
Postoperative complications	bleeding, leak, pulmonary embolus, stricture, other	through study completion on average 1 year
Functional results	weight loss in Kg as compared to preoperative weight	through study completion on average 1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Hypertension; Obesity, Morbid; Hypertension, Portal
• Other Study ID Numbers: 22Chirdig01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Not scheduled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No