Clinical trial NCT01980420: Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Official title: Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Sleeve gastrectomy
Oesogastric junction - GEJ
Dynamic MRI Imaging
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with postoperative GIQLI score greater than preoperative score
timeFrame: 50% excess weight loss (about 6 months post surgery)
Secondary outcomes:
measure: Quality of life (GIQLI)
timeFrame: 50% of excess weight loss (about 6 months post surgery)
measure: GERD and dysphagia symptoms (GSAS questionnaire)
timeFrame: 50% of excess weight loss (about 6 months post surgery)
measure: Functional examinations
timeFrame: 50% of excess weight loss (about 6 months post surgery)
measure: EndoFLIP® measures
timeFrame: Intra-operatively
measure: Surgical video analysis
timeFrame: within 6 months post surgery
measure: Per and post-operative complications
timeFrame: within 6 months post surgery
measure: Cost of exploratory exams
timeFrame: 50% excess weight loss (about 6 months post surgery)
measure: Cost of exploratory exams
timeFrame: Within 2 months prior to surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg
name: Silvana Perretta, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quero G, Fiorillo C, Dallemagne B, Mascagni P, Curcic J, Fox M, Perretta S. The Causes of Gastroesophageal Reflux after Laparoscopic Sleeve Gastrectomy: Quantitative Assessment of the Structure and Function of the Esophagogastric Junction by Magnetic Resonance Imaging and High-Resolution Manometry. Obes Surg. 2020 Jun;30(6):2108-2117. doi: 10.1007/s11695-020-04438-y.