The Diagnostic Value of Combinatory EUS and ERCP in Uncle... | NCT03504293

Studies
The Diagnostic Value of Combinatory EUS and ERCP in Unclear Lesions

NCT03504293

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 22, 2020Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Neoplasms
Biliary Stricture
Biliary Tract Neoplasms
Biliary Tract Diseases

Interventions

Combinatory EUS and ERCP

Countries

Sweden

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

Dec 2020

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, 2010Actual

Primary Completion Date

Nov 30, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Apr 12, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 20, 2018Actual

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

Dec 19, 2020

Last Update Posted Date

Dec 22, 2020Actual

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

ERCP with brush cytology has a poor to moderate accuracy in unclear biliary lesions. Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology may override some of these shortcomings.

The current prospective study, performed in a tertiary University center, aims to study the feasibility, the accuracy and the clinical value of combinatory ERCP and EUS in unclear biliary lesions.

Detailed Description

The eligible study participants with unclear biliary lesions referred for an ERCP to the Sahlgrenska Univeristy Hospital endoscopy unit will be subjected to ERCP with/without brush cytology followed by EUS with/without FNA.

The results of ERCP and EUS will be compared to the pathology report of surgical specimens in resected patients or to clinical follow up at 12 months post-EUS in non-resected patients.

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

90Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combinatory EUS and ERCP	Procedure	EUS performed as a supplementary procedure in addition to ERCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	Overall accuracy of ERCP and EUS	12 months post-EUS

Secondary Outcomes

Measure	Description	Time Frame
Adverse event rate	The number of patients ending up with some type of complication related to ERCP or EUS	30 days post-EUS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with unclear lesions or strictures in the biliary tract referred for endoscopy work up

Exclusion Criteria:

Patients unwilling to participate
Patients unfit for EUS and ERCP

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 unclear lesions or strictures in the biliary tract

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Riadh Sadik, Ass Prof	Sahlgrenska University Hospital, Gothenburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Gothenburg		413 45	Sweden

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
D009369	Neoplasms
D001661	Biliary Tract Neoplasms
D001660	Biliary Tract Diseases

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002760	Cholangiopancreatography, Endoscopic Retrograde

Ancestor Terms

ID	Term
D002758	Cholangiography
D011860	Radiography, Abdominal
D011859	Radiography
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided