Endoscopic Submucosal Dissection Registry | NCT06033976

Studies
Endoscopic Submucosal Dissection Registry

NCT06033976

Sponsor

Carol Davila University of Medicine and Pharmacy

Status

Recruiting

Last Update Posted

Nov 12, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Neoplasm, Stomach
Neoplasm, Colorectal
Neoplasm, Esophagus
Neoplasm, Duodenal

Interventions

Endoscopic submucosal dissection (ESD)

Countries

Romania

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

Nov 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

Jan 1, 2021Actual

Primary Completion Date

Jan 2031Estimated

Completion Date

Jan 2031Estimated

First Submitted Date

Sep 3, 2023

First Submission Date that Met QC Criteria

Sep 10, 2023

First Posted Date

Sep 13, 2023Actual

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

Nov 9, 2024

Last Update Posted Date

Nov 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mihai Ciocirlan, Clinical Professor (Associate Professor), Carol Davila University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Carol Davila University of Medicine and PharmacyOTHER

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

This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Detailed Description

Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic submucosal dissection (ESD)	Procedure	Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.		ESD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of curative resection		through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Rate of R0 resection		through study completion, an average of 1 year

Other Outcomes

Measure	Description	Time Frame
Rate of perforation		30 days
Rate of delayed bleeding		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa
non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa
age > 18 years old
informed consent

Exclusion Criteria:

age < 18 years old
no informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed at or referred to Gastroenterology Clinic, University of Medicine and Pharmacy, "Agrippa Ionescu" Hospital, Bucharest, Romania

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ciocirlan L Mihai, Associate Professor	Contact	0040722322625		mihai.ciocirlan@umfcd.ro

Overall Officials

Name	Affiliation	Role
Mihai L Ciocirlan, Associate Professor	Carol Davila University of Medicine and Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Agrippa Ionescu" Hospital	Recruiting	Bucharest			Romania

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

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D015179	Colorectal Neoplasms
D004938	Esophageal Neoplasms
D004379	Duodenal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

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