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

NCT ID: NCT01980420

Last Updated: 2016-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-06-30

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).

Conditions

Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleeve gastrectomy

All patients will undergo sleeve gastrectomy

Group Type: OTHER

Laparoscopic sleeve gastrectomy

Intervention Type: PROCEDURE

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

Interventions

Laparoscopic sleeve gastrectomy

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

Intervention Type: PROCEDURE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvana Perretta, Pr

Role: PRINCIPAL_INVESTIGATOR

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Locations

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32207049 (View on PubMed)

Other Identifiers

2013-A00723-42

Identifier Type: OTHER

Identifier Source: secondary_id

13-001

Identifier Type: -

Identifier Source: org_study_id