Evaluation of the Resection of Adenoma and Colic Adenocar... | NCT02935049

Studies
Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique

NCT02935049

Sponsor

Institut Paoli-Calmettes

Status

Unknown status

Last Update Posted

Oct 26, 2017Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Colorectal Adenoma
Intramucinous Adenocarcinoma

Interventions

Endoscopic resection

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 17, 2016Estimated

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

Oct 25, 2017

Last Update Posted Date

Oct 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic resection	Procedure	Endoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse rate	Medical follow-up	From surgery to 1 year

Secondary Outcomes

Measure	Description	Time Frame
Complications rate	haemorrhage or perforation	From surgery to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years,
Patient with colorectal adenoma or intramucinous adenocarcinoma

Exclusion Criteria:

Contraindication surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colorectal adenoma or intramucinous adenocarcinoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
GENRE Dominique, MD	Contact	+33 (4) 91 22 37 78		drci.up@ipc.unicancer.fr
COURNIER Sandra, Project Manager	Contact	+33 (4) 91 22 37 78		drci.up@ipc.unicancer.fr

Overall Officials

Name	Affiliation	Role
RATONE Jean Philippe, MD	Institut Paoli-Calmettes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GENRE	Recruiting	Marseille		13273	France

Label	URL
Institut Paoli-Calmettes	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069916	Endoscopic Mucosal Resection

Ancestor Terms

ID	Term
D016099	Endoscopy, Gastrointestinal
D016145	Endoscopy, Digestive System
D003938	Diagnostic Techniques, Digestive System
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided