Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP... | NCT04770857

Studies
Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis

NCT04770857

Sponsor

Nicola Frei

Status

Unknown status

Last Update Posted

Jul 29, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Visual analogue scale

Countries

Switzerland

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

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Estimated

Primary Completion Date

May 2023Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Feb 22, 2021

First Submission Date that Met QC Criteria

Feb 22, 2021

First Posted Date

Feb 25, 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 28, 2021

Last Update Posted Date

Jul 29, 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

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from < 2% up to 40%.

Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP.

This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual analogue scale	Other	Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between Pain 1 hour after ERCP		1 hour

Secondary Outcomes

Measure	Description	Time Frame
Predictive value of VAS for PEP Predictive value of VAS for PEP		1 hour
Association between VAS level and severity of PEP		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Scheduled for ERCP for any reason

Exclusion Criteria:

Absence of consent
Language barrier
No endoscopic advance to the papilla vateri
Active pancreatitis at the time of the procedure
Mental disability

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 patients scheduled for ERCP for any reason at the study center will be asked for participation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nicola Fabian Frei, MD	Contact	+41 71 494 99 68		nicolafabian.frei@kssg.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Sankt Gallen		Sankt Gallen		9007	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided