Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

Study Overview
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Brief Summary
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Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

Detailed Description
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Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the ideal gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).

Official Title
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Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Laparoscopic sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient, male or female over 18 years old Patient scheduled to undergo a sleeve gastrectomy for obesity Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP) Patient able to understand the study and to provide written informed consent Patient registered with the French social security regime Non-inclusion criteria: Patient unable to give written informed consent Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices) Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium) Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures Patient pregnant or breast-feeding Patient within exclusion period from other clinical trial Patient having forfeited their freedom of an administrative or legal obligation Patient being under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleeve gastrectomy<br>All patients will undergo sleeve gastrectomy | Procedure: Laparoscopic sleeve gastrectomy<br>* Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative GIQLI score greater than preoperative score | Patients with postoperative GIQLI (Gastro-Intestinal Quality of Life Index) score greater than preoperative score | 50% excess weight loss (about 6 months post surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (GIQLI) | Quality of life (Gastro-Intestinal Quality of Life Index) | 50% of excess weight loss (about 6 months post surgery) | 
| GERD and dysphagia symptoms (GSAS questionnaire) | GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale | 50% of excess weight loss (about 6 months post surgery) | 
| Functional examinations | Include: Dynamic MRI High resolution manometry pH impedance upper gastro-intestinal study (UGI) | 50% of excess weight loss (about 6 months post surgery) | 
| EndoFLIP® measures | Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure | Intra-operatively | 
| Surgical video analysis | Analysis of surgery videos to detect technical errors explaining clinical and/or functional outcome | within 6 months post surgery | 
| Per and post-operative complications | Complications occuring during surgery and within 6 months of surgery (reach of 50% of excess weight loss) | within 6 months post surgery | 
| Cost of exploratory exams |  | 50% excess weight loss (about 6 months post surgery) | 
| Cost of exploratory exams |  | Within 2 months prior to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleeve gastrectomy, Oesogastric junction - GEJ, Dynamic MRI Imaging