Endoscopic Resection of Early Esophageal Tumors in the Co... | NCT04994548

Studies
Endoscopic Resection of Early Esophageal Tumors in the Context of Cirrhosis or Portal Hypertension

NCT04994548

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Aug 6, 2021Actual

Enrollment

112Actual

Phase

Not provided

Conditions

Esophageal Neoplasms
Cirrhosis
Portal Hypertension

Interventions

Endosocpic resection of early esophageal tumor

Countries

Not provided

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2005Actual

Primary Completion Date

Feb 3, 2005Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Jul 29, 2021

First Submission Date that Met QC Criteria

Jul 29, 2021

First Posted Date

Aug 6, 2021Actual

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 29, 2021

Last Update Posted Date

Aug 6, 2021Actual

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

Cirrhotic patients may be at high risk for esophageal cancer. Endoscopic resection is the standard treatment for superficial tumors. However, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. This study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection.

This retrospective multicentric French-Belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from January 2005 to 2021.

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

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cirrhotic patients or with portal hypertension		Patients with early esophageal cancer	Procedure: Endosocpic resection of early esophageal tumor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endosocpic resection of early esophageal tumor	Procedure	under general anesthesia, by mucosectomy or endoscopic submucosal dissection	Cirrhotic patients or with portal hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
technical success of early esophageal cancer resection	defined by a complete macroscopic resection	baseline

Secondary Outcomes

Measure	Description	Time Frame
adverse events per procedure (immediate bleeding, perforation)		baseline
morbidity post procedure (delayed bleeding, infection, esophageal stenosis, 30-days related liver decompensation, 30-days related mortality)		up to 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Exclusion Criteria:

younger than 18

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

112 patients with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor

Sampling Method

Not provided

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
D004938	Esophageal Neoplasms
D005355	Fibrosis
D006975	Hypertension, Portal

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