Condition category
Digestive System
Date applied
17/05/2017
Date assigned
26/05/2017
Last edited
10/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cirrhosis occurs when the liver becomes scarred due to long-term damage. It can stop the liver from working properly, causing liver failure. A main risk factor for liver cirrhosis is from being obese or overweight. When people are obese, they sometimes undergo a weight loss surgery called bariatric surgery. This is a major operation that either removes a part of stomach or puts a band over it so that patients feel full. It can help reduce the chances of liver cirrhosis, among many other obesity related conditions. The aim of this study is to analyse the effects of obesity surgery in patients with liver cirrhosis to see if patients with liver cirrhosis that undergo the surgery have different complication rates, if they surgery is effective with weight loss and if it helps improve liver function.

Who can participate?
Adults aged 18 to 70 with obesity and liver cirrhosis who had bariatric surgery

What does the study involve?
Participants who have undergone a bariatric surgery are included in this study and have their medical records reviewed. Data is reviewed before and their surgery to see if they had any complications, to review their weight and height, compare blood analyses, and to see if their liver function has improved.

What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating.

Where is the study run from?
This study is taking place in 19 hospitals in Spain

When is the study starting and how long is it expected to run for?
January 2017 to March 2018

Who is funding the study?
Organisation Spanish Society of Endocrinology and Nutrition (SEEN) (Spain)

Who is the main contact?
Dr Inka Miñambres
iminambres@santpau.cat

Trial website

Contact information

Type

Scientific

Primary contact

Dr Inka Miñambres

ORCID ID

Contact details

Endocrinology Services
Hospital de la Santa Creu i Sant Pau
C/ Mas Casanovas 90
Barcelona
08026
Spain
+34 93 55 65 661
iminambres@santpau.cat

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IIBSP-BAR-2016-108

Study information

Scientific title

BARiatric surgery in patients with liver CIRRhOsis

Acronym

CIRROBAR

Study hypothesis

The aim of this study is to assess short and long-term evolution and complications of patients with liver cirrhosis and obesity that are submitted to obesity surgery in Spain.

Ethics approval

Ethics Committee of the Research Institute of Hospital de la Santa Creu i Sant Pau – IIB Sant Pau, 01/03/2017, ref: IIBSP-BAR-2016-108

Study design

Observational multi-centre retrospective case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Obesity

Intervention

This is a retrospective study. Participants are included for this study if they already have had a bariatric surgery and have been followed up since the surgery date until the inclusion data in the study by their endocrinology team.

Eligible participants have clinical and analytical data collected from their baseline visit prior to surgery. Then, participants undergo the surgery and then have their routine follow up visits. The number of follow up visits differs from one patient to another according to their date of surgery. Data is collected yearly from when the surgery occurred until the present. The data collected from participants include age, date of surgery, type of surgery, weight, height and BMI, presence of diabetes, cause of cirrhosis, hepatic biopsa, blood tests, and any complications they may have.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Short and long term evolution of patients with liver cirrhosis submitted to obesity surgery is measured using patient records at 1 month and one year after bariatric surgery and for long term evolution, at the last visit in each patient

Secondary outcome measures

1. Causes of cirrhosis, staging (Child, MELD) and degree of hepatic insufficiency (albumin, platelets, INR, liver function tests) are measured using patient records at the last pre-surgical visit
2. Hepatic pathology after bariatric surgery (staging (Child, MELD), degree of liver failure (albumin, platelets, INR, liver function tests), liver biopsies, hepatic decompensations postIQ (encephalopathy, ascites, Bleeding), development of hepatocarcinoma)) are measured using patient records at the patients last follow up visit
3. Frequency of early complications are measured using patient records at early postoperative (<30 days post surgery) or late (> 30 days post surgery)
4. Obesity comorbidities (diabetes, hypertension, dyslipidemia, SAHS) are measured using patient records at the last pre-surgical visit and at each year after surgery until study inclusion
5. Body weight is measured using patient records at the last pre-surgical visit and at each year after surgery until study inclusion

Overall trial start date

01/01/2017

Overall trial end date

01/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient with obesity and liver cirrhosis submitted to bariatric surgery in Spain
2. Aged 18 to 70 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Minimum of 30 pacients

Participant exclusion criteria

Not applicable

Recruitment start date

01/06/2017

Recruitment end date

01/12/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital de la Santa Creu i Sant Pau
Carrer de Sant Quintí 89
Barcelona
08026
Spain

Trial participating centre

Hospital del Mar
Passeig Marítim 25-29
Barcelona
08003
Spain

Trial participating centre

Hospital Arnau de Vilanova
Av. Alcalde Rovira Roure 80
Lleida
25198
Spain

Trial participating centre

Hospital Universitario Reina Sofía.
Av. Menéndez Pidal, s/n 14004
Córdoba
14004
Spain

Trial participating centre

Hospital Vall d’Hebron
Passeig de la Vall d'Hebron 119-129
Barcelona
08035
Spain

Trial participating centre

Hospital Universitari Parc Taulí
Parc Taulí, 1 Sabadell
Barcelona
08208
Spain

Trial participating centre

Hospital Universitario A Coruña
As Xubias, 84 15006 A Coruña
La Coruña
15006
Spain

Trial participating centre

Hospital Virgen de la Victoria
Campus de Teatinos S/N
Málaga
29010
Spain

Trial participating centre

Hospital Universitario Gregorio Marañón
Calle del Dr. Esquerdo 46
Madrid
28007

Trial participating centre

Clínica Universidad de Navarra.
Av. de Pío XII 36 31008 Navarra
Pamplona
31008
Spain

Trial participating centre

Hospital Clínic i Universitari
Carrer de Villarroel 170
Barcelona
08036
Spain

Trial participating centre

Complejo Asistencial Universitario de León
Calle Altos de nava s/n
León
24001
Spain

Trial participating centre

Hospital Valle del Nalón Asturias
33920 Polígono de Riaño 1
Langreo
33920
Spain

Trial participating centre

Complexo Hospitalario Universitario de Vigo, Pontevedra
Estrada de Clara Campoamor 341 Vigo Pontevedra
Vigo
36312
Spain

Trial participating centre

Hospital Clínico San Carlos
Calle del Prof Martín Lagos s/n
Madrid
28040
Spain

Trial participating centre

Hospital Universitario de Bellvitge
Carrer de la Feixa Llarga s/n L'Hospitalet de Llobregat
Barcelona
08907
Spain

Trial participating centre

Hosp. Univ. Virgen del Rocio de Sevilla
Av. Manuel Siurot
Sevilla
41013
Spain

Trial participating centre

Hospital Regional Universitario de Málaga
Av. de Carlos Haya s/n
Málaga
29010
Spain

Trial participating centre

Hospital Universitari Germans Trias i Pujol
Carretera de Canyet, S/N, 08916 Badalona
Barcelona
08916
Spain

Sponsor information

Organisation

Organisation Spanish Society of Endocrinology and Nutrition (SEEN)

Sponsor details

c/Villalar 7 Bajo-interior Derecha
Madrid
28001
Spain
+34 914 313 294
secretaria@seen.es

Sponsor type

Research organisation

Website

www.seen.es

Funders

Funder type

Research organisation

Funder name

Organisation Spanish Society of Endocrinology and Nutrition (SEEN)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/03/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

10/08/2017: Internal review.