Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 5:07 AM
Study NCT ID:
NCT01980420
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Sponsor:
IHU Strasbourg
Organization:
Study Overview
Official Title:
Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FFSI
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-A00723-42 | OTHER | ANSM France | View |