Bariatric Surgery CandidateBARIAPORTALNCT05653115
Portal Hypetension and Bariatric Surgery (BARIAPORTAL)
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity, Morbid, Portal Hypertension
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery
Who may be able to join
- 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)
Who cannot join
- Absence of preoperative evidence of CSPH in spite of evidence liver cirrhosis.
- Absence of information to determine at least postoperative mortality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Individuals with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative mortality
number of patients who died after the surgery
Measured: Within 90 of surgery or any tipe during postoperative hospital stay
Secondary outcomes (8)
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).
Measured: through study completion on average 1 year
Etiology of liver cirrhosis
viral (HCV, HBV), NASH, Alcohol, other
Measured: 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).
Measured: 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)
Measured: through study completion on average 1 year
Strategy to lower portal hypertension
TIPS, Beta blockers
Measured: through study completion on average 1 year
Type of bariatric procedure
SG, RYGB, Band, other
Measured: through study completion on average 1 year
Postoperative complications
bleeding, leak, pulmonary embolus, stricture, other
Measured: through study completion on average 1 year
Functional results
weight loss in Kg as compared to preoperative weight
Measured: through study completion on average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start12 Jan 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653115
- Sponsor's protocol ID
- 22Chirdig01
- Acronym
- BARIAPORTAL
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not scheduled
Publications
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.
PubMed 38819255
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Bariatric Surgery in the Setting of Compensated Advance+B9d Chronic Liver Disease Associated With Clinically Significant Portal Hypertension
- ClinicalTrials.gov ID
- NCT05653115
- Acronym / sponsor ID
- BARIAPORTAL / 22Chirdig01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | – | Procedure: Bariatric surgeryIndividuals with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with morbid obesity and clinically relevant portal hypertension undergoing bariatric surgery
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Absence of preoperative evidence of CSPH in spite of evidence liver cirrhosis.
- Absence of information to determine at least postoperative mortality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgeryBariatric surgery | Procedure or surgery | Bariatric surgery |
Primary outcome
Postoperative mortality
Time frame: Within 90 of surgery or any tipe during postoperative hospital stay
number of patients who died after the surgery
8 secondary outcomes
General information and anthropometrics
Time frame: through study completion on average 1 year
Etiology of liver cirrhosis
Time frame: through study completion on average 1 year
Preoperative work-up to define CSPH
Time frame: through study completion on average 1 year
Liver function
Time frame: through study completion on average 1 year
Strategy to lower portal hypertension
Time frame: through study completion on average 1 year
Type of bariatric procedure
Time frame: through study completion on average 1 year
Postoperative complications
Time frame: through study completion on average 1 year
Functional results
Time frame: through study completion on average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Results publication: PubMed 38819255Temime 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.
- Individual participant dataSharing planned: No. Not scheduled
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate and Obesity, Morbid, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative mortality (time frame: Within 90 of surgery or any tipe during postoperative hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05653115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.