Anti-Migration System for Anti-reflux Oeso-gastric Stent... | NCT05431738

Studies
Anti-Migration System for Anti-reflux Oeso-gastric Stent (ANTIMIG)

NCT05431738

Sponsor

Société Française d'Endoscopie Digestive

Status

Recruiting

Last Update Posted

Jul 30, 2024Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Stent Migration
GastroEsophageal Cancer

Interventions

Gastroesophageal stent placement

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Jun 19, 2022

First Submission Date that Met QC Criteria

Jun 19, 2022

First Posted Date

Jun 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2024

Last Update Posted Date

Jul 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

KARSENTI, Principal Investigator, Société Française d'Endoscopie DigestivePrincipal Investigator

Lead Sponsor

Société Française d'Endoscopie DigestiveOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this prospective, controlled, randomized, multicentre, single-blind study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

Detailed Description

In order to reduce the rate of spontaneous intragastric migration of esophageal stent placed for gastroesophageal junction tumor, anti-migration device has been developed. Pilot studies suggest the absence of morbidity of this device, but no comparative study has been conducted to confirm the interest of this anti-migration device.

The aim of this study is to compare the rate of intragastric migration of 2 types of esophageal stents with and without an anti-migration device placed for locally advanced or metastatic malignant stenosis of the gastroesophageal junction.

Main objective: To evaluate the rate of intragastric migration of 2 types of esophageal stents (one with and the second without anti-migration device) placed for malignant stenosis of the gastroesophageal junction.
Secondary objective(s):
- Degraded migration rate (M3 and M6) if patient alive, and duration of survival without dysphagia
- Comparison of the morbidity of these two stents
- Comparison of the effectiveness of these two stents on dysphagia and reflux
- Clinical and technical failure rate of these two stents

This is a prospective, controlled, randomized, multicentre, single-blind study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
STENT WITH ANTI-MIGRATION DEVICE	Active Comparator	Placement of a gastroesophageal stent with anti-migration device : Ella®, Leufen, Novatech	Device: Gastroesophageal stent placement
STENT WITHOUT ANTI-MIGRATION DEVICE	Active Comparator	Placement of a gastroesophageal stent without anti-migration device : Hanarostent® ECW, Life Partners Europe	Device: Gastroesophageal stent placement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastroesophageal stent placement	Device	A gastroesophageal stent is placed during a digestive endoscopy performed under general anesthesia, under endoscopic and fluoroscopic control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stent Intragastric migration rate at M1	Stent Intragastric migration rate at M1 confirmed on radiography or CT	1 month

Secondary Outcomes

Measure	Description	Time Frame
Stent Intragastric migration rate at M3	Stent Intragastric migration rate at M3 confirmed on radiography or CT	3 months
Stent Intragastric migration rate at M6	Stent Intragastric migration rate at M6 confirmed on radiography or CT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient of both sexes aged 18 or over.
Patient admitted to one of the investigation centers for dysphagia due to tumoral stenosis of the gastroesophageal junction, locally advanced or metastatic.
Patient ASA 1, ASA 2, ASA 3
Absence of participation in another clinical study
Signed Informed Consent
Patients benefiting from the social security system.

Exclusion Criteria:

Patient referred for stenosis by extrinsic compression by an extra digestive mass
Patients with contraindications relating to the procedures essential for the introduction of a stent
Mediastinal radiotherapy or esophageal surgery history
Patient under 18 or over 90
Patient ASA 4, ASA 5
Pregnant Woman
Patient unable to give personal consent
Absence of signed informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

91 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David KARSENTI, MD	Contact	+33603454293		karsenti@club-internet.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
French Society of Digestive Endoscopy	Recruiting	Paris		75006	France

Condition Browse Module

MeSH Terms

ID	Term
D004940	Esophageal Stenosis
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

The stent is placed under endoscopy during general anesthesia. The type of stent is not specified in the endoscopy report. The patient is not informed of the type of esophageal stent placed.

Who Masked

Participant