Evaluation of "PreCut-Papillectomy" in Difficult Biliary... | NCT06310460

Studies
Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation

NCT06310460

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Cholangiopancreatography, Endoscopic Retrograde

Interventions

Papillectomy

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Feb 28, 2025Estimated

First Submitted Date

Mar 7, 2024

First Submission Date that Met QC Criteria

Mar 7, 2024

First Posted Date

Mar 15, 2024Actual

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

Mar 7, 2024

Last Update Posted Date

Mar 15, 2024Actual

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

To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation.

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Papillectomy	Procedure	Papillectomy prior to bile duct cannulation during ERCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of treatment success	Rate of successful cannulation of the bile duct after PreCut-papillectomy	During endoscopy
Adverse event rate	Rate of adverse events, as classifed by ASGE classification	Up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Difficult cannulation of bile duct

Exclusion Criteria:

post-surgical upper GI anatomy
previous endoscopic retrograde cholangiopancreaticography or percutaneous transhepatic cholangiography
papilla within a diverticulum
coagulation disorder

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 undergoing ERCP with intented bile duct cannulation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Wannhoff, Dr.	Contact	+49-7141-67204		Andreas.Wannhoff@rkh-gesundheit.de

Overall Officials

Not provided

Locations

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