Liver TransplantationESGiTXNCT05760235
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates
A study testing Endoscopic sleeve gastroplasty (ESG) in people with Liver Transplantation and Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Obesity, Bariatric Surgery
- What is being tested?
- Endoscopic sleeve gastroplasty (ESG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 13 Oct 2022to Nov 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (i.e., age between 18 and 70 years).
- BMI ≥ 35 kg/m²;
- Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
- Signed informed consent.
Who cannot join
- Clinically significant portal hypertension at upper endoscopy: F3 or F1/F2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy;
- Upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months;
- CHILD C class;
- Clinically or ultrasound-detected ascites in the 15 days before the procedure. Only mild ascitic effusion in the pelvis will be accepted;
- Spontaneous bacterial peritonitis in the previous 6 months;
- Hepatocellular carcinoma with extra hepatic spread;
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- Previous stomach, oesophagus or duodenum surgery;
- Technical non-feasibility in the opinion of the endoscopist;
- Clinical signs of active infection;
- Unstable cardiac disease or chronic heart failure;
- Platelet count less than 70.000;
- International Normalized Ratio ≥ 1,5;
- Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
- Acute liver failure;
- Easy to bleed during diagnostic endoscopy;
- Active drugs or alcohol abuse;
- Pregnancy, lactation (desire to become pregnant during study duration);
- Enrolment in other clinical studies;
- Contraindication to general anaesthesia;
- Contraindication to endoscopic procedure;
- Other conditions to exclude the subject in investigators opinion;
- Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, Lazio, 00168
Giuseppe Marrone, +39 0630157779, giuseppe.marrone@policlinicogemelli.it
About this study
The goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question[s] it aims to answer are:
- Is the procedure effective in reducing BMI to the target level in 12 months?
- Which is the effect on weight loss, quality of life and obesity-related comorbidities?
Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation
- Conditions
- Liver Transplantation, Obesity, Bariatric Surgery
- Being tested
- Endoscopic sleeve gastroplasty (ESG)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplasty (ESG)Procedure or surgery
ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free15. The procedure will be performed with the patient in supine position. Carbon dioxide will be blown to stretch the gastric lumen. An initial endoscopic evaluation will be performed immediately to confirm the absence of any contraindication to ESG before suturing. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant obese candidates | Experimental | Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2) Receives: Procedure: Endoscopic sleeve gastroplasty (ESG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant list inclusion
number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start13 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760235
- Sponsor's protocol ID
- 4903
- Acronym
- ESGiTX
- Status last verified
- Feb 2024
- First submitted
- 27 Feb 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Liver Transplant Candidates
- ClinicalTrials.gov ID
- NCT05760235
- Acronym / sponsor ID
- ESGiTX / 4903
- Conditions
- Liver Transplantation, Obesity, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 8 Mar 2023 (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 goal of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects with the need of liver transplantation to reduce their BMI in order to enter the waiting list (BMI (≥35 kg/m2). The main question[s] it aims to answer are:
- Is the procedure effective in reducing BMI to the target level in 12 months?
- Which is the effect on weight loss, quality of life and obesity-related comorbidities?
Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant obese candidates | Experimental | Procedure: Endoscopic sleeve gastroplasty (ESG)Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (i.e., age between 18 and 70 years).
- BMI ≥ 35 kg/m²;
- Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
- Signed informed consent.
Key exclusion criteria (22 listed)
- Clinically significant portal hypertension at upper endoscopy: F3 or F1/F2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy;
- Upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months;
- CHILD C class;
- Clinically or ultrasound-detected ascites in the 15 days before the procedure. Only mild ascitic effusion in the pelvis will be accepted;
- Spontaneous bacterial peritonitis in the previous 6 months;
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 |
|---|---|---|
| Endoscopic sleeve gastroplasty (ESG)ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free15. The procedure will be performed with the patient in supine position. Carbon dioxide will be blown to stretch the gastric lumen. An initial endoscopic evaluation will be performed immediately to confirm the absence of any contraindication to ESG before suturing. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch. | Procedure or surgery | Liver transplant obese candidates |
Primary outcome
Transplant list inclusion
Time frame: 12 months
number of patients who achieve a BMI < 35 kg/m² within 12 months post-ESG, allowing them to be included in the transplant list
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic sleeve gastroplasty (ESG) in people with Liver Transplantation and Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Marrone (+390630157779, giuseppe.marrone@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant list inclusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2024.