The ESG Integrity Study: Effect of Proton Pump Inhibitors... | NCT06283381

Studies
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

NCT06283381

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Feb 28, 2024Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Obesity

Interventions

Esomeprazole

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2024Actual

Primary Completion Date

Jan 31, 2025Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Feb 20, 2024

First Submission Date that Met QC Criteria

Feb 27, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2024

Last Update Posted Date

Feb 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:

Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.
Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).

The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: experimental group	Experimental	no administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty	Drug: Esomeprazole
Arm B: standard of care group	Active Comparator	administration of Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for another 4 weeks after the Endoscopic Sleeve Gastroplasty	Drug: Esomeprazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esomeprazole	Drug	oral administration, tablets, 40 mg	Arm A: experimental group Arm B: standard of care group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)	The structural integrity of the ESG will be defined as opened (all stitches loose), partially intact (at least one stitch loose), or intact (all stitches tight).	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20 to 65 years
BMI between 30 to 45 kg/m2
Willingness to participate in the study and ability to comply and understand the study protocol.

Exclusion Criteria:

Active gastric gastro-duodenal during the last 6 months
Helicobacter pylori infection.
Organic or motility disorder of the stomach and / or esophagus
Anticoagulant treatment
Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
Ongoing or active malignancy during the last 5 years.
Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
Drug or alcohol abuse
Bulimic or binge eating pattern
Continuous glucocorticoid or anti-inflammatory treatment
Uncontrolled thyroid disease.
Pregnancy, breastfeeding
Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
Hiatal hernia ≥ 5 cm
Known allergy or hypersensitivity to the active substance or any of the other excipients
Liver cirrhosis of any Child-Phugh stage or MELD> 15
Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D009853	Omeprazole
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds