Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

Bariatric Surgery Candidate Clinical Trial

— BARIAPORTAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653115
• Other study ID #: 22Chirdig01
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Antonio IANNELLI
• Phone: +33492036376
• Email: iannelli.a[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2023
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Hypertension
• Hypertension, Portal
• Obesity, Morbid
• Portal Hypertension

Intervention

Procedure:
• Bariatric surgery
Bariatric surgery

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative mortality	number of patients who died after the surgery	Within 90 of surgery or any tipe during postoperative hospital stay
Secondary	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
Secondary	Etiology of liver cirrhosis	viral (HCV, HBV), NASH, Alcohol, other	through study completion on average 1 year
Secondary	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
Secondary	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
Secondary	Strategy to lower portal hypertension	TIPS, Beta blockers	through study completion on average 1 year
Secondary	Type of bariatric procedure	SG, RYGB, Band, other	through study completion on average 1 year
Secondary	Postoperative complications	bleeding, leak, pulmonary embolus, stricture, other	through study completion on average 1 year
Secondary	Functional results	weight loss in Kg as compared to preoperative weight	through study completion on average 1 year