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

Morbid Obesity Clinical Trial

— FFSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980420
• Other study ID #: 13-001
• Secondary ID: 2013-A00723-42
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: August 31, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Quality of life (GIQLI)	Quality of life (Gastro-Intestinal Quality of Life Index)	50% of excess weight loss (about 6 months post surgery)	No
Secondary	GERD and dysphagia symptoms (GSAS questionnaire)	GERD (Gastroesophageal Reflux Disease) Symptom Assessment Scale	50% of excess weight loss (about 6 months post surgery)	No
Secondary	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)	No
Secondary	EndoFLIP® measures	Measurements provided by EndoFlip probe : GEJ distensibility, diameter, pressure	Intra-operatively	No
Secondary	Surgical video analysis	Analysis of surgery videos to detect technical "errors" explaining clinical and/or functional outcome	within 6 months post surgery	No
Secondary	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	Yes
Secondary	Cost of exploratory exams		50% excess weight loss (about 6 months post surgery)	No
Secondary	Cost of exploratory exams		Within 2 months prior to surgery	No