Endoscopic Versus Radiologic Biliary Drainage for Perihil... | NCT05078801

Studies
Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction

NCT05078801

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Oct 15, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Perihilar Cholangiocarcinoma
Jaundice, Obstructive

Interventions

Endoscopic drainage
Percutaneous transhepatic biliary drainage

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2021Actual

Primary Completion Date

Jul 31, 2022Estimated

Completion Date

Oct 30, 2022Estimated

First Submitted Date

Aug 5, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 15, 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

Oct 1, 2021

Last Update Posted Date

Oct 15, 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

This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.

Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endoscopic drainage		All patients with perihilar malignant biliary obstruction treated with endoscopic drainage. This drainage can be multimodal using endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS)-guided biliary drainage.	Procedure: Endoscopic drainage
Radiologic percutaneous drainage		All patients with perihilar malignant biliary obstruction treated with percutaneous drainage	Procedure: Percutaneous transhepatic biliary drainage

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic drainage	Procedure	ERCP and/or EUS-guided biliary drainage	Endoscopic drainage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bilirubin serum level	Diminution of 20% of more on day 7 of the bilirubin serum level	7 days

Secondary Outcomes

Measure	Description	Time Frame
Complications	complication-free survival	16 years
number of procedures	total number of procedures, including all endoscopic and radiological interventions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hospitalization between january 2006 and march 2022
perihilar obstruction
indication of biliary drainage

Exclusion Criteria:

distal biliary obstruction
perihilar obstruction without indication of biliary drainage

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

all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nancy Hospital Center		Nancy		54000	France

Condition Browse Module

MeSH Terms

ID	Term
D018285	Klatskin Tumor
D041781	Jaundice, Obstructive

Ancestor Terms

ID	Term
D018281	Cholangiocarcinoma
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial

Browse Leaves

Not provided

Browse Branches

Not provided