Portal Hypetension and Bariatric Surgery (BARIAPORTAL)

NCT05653115 | Completed

• 1 other identifier: 22Chirdig01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate; Obesity, Morbid; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Postoperative mortality

  number of patients who died after the surgery

  Within 90 of surgery or any tipe during postoperative hospital stay

Secondary Outcomes (8)

• General information and anthropometrics

  through study completion on average 1 year

• Etiology of liver cirrhosis

  through study completion on average 1 year

• Preoperative work-up to define CSPH

  through study completion on average 1 year

• Liver function

  through study completion on average 1 year

• Strategy to lower portal hypertension

  through study completion on average 1 year

Study Arms (1)

Bariatric surgery

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

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

Bariatric surgery

Bariatric surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Absence of preoperative evidence of CSPH in spite of evidence liver cirrhosis.
• Absence of information to determine at least postoperative mortality.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06200, France

Location

Related Publications (1)

• 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.

  PMID: 38819255 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Hypertension, Portal

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 16, 2022
• Study Start: January 12, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)