Relationship of CP and AP | NCT04670705

Studies
Relationship of CP and AP

NCT04670705

Sponsor

Changhai Hospital

Status

Completed

Last Update Posted

Dec 17, 2020Actual

Enrollment

1,022Actual

Phase

Not provided

Conditions

Chronic Pancreatitis
Acute Pancreatitis

Interventions

patients' characteristics

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

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 2010Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Oct 2020Actual

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Dec 15, 2020

First Posted Date

Dec 17, 2020Actual

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 15, 2020

Last Update Posted Date

Dec 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The present study aimed to determine the prevalence of AP attacks before the diagnosis of CP and further identified the potential associated factors for AP episodes.

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

1,022Actual

Name	Type	Description	Arm Group Labels	Other Names
patients' characteristics	Other	There was no intervention.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the occurrence of acute pancreatitis	the presence and frequency of acute pancreatitis before diagnosis of CP	Baseline (before the diagnosis of CP)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Consequent patients with a diagnosis of CP between January 2010 to December 2015
informed consents provided

Exclusion Criteria:

autoimmune pancreatitis (AIP)
pancreatic cancer diagnosed within 2 years after the diagnosis of CP

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consequent patients with a diagnosis of CP were enrolled between January 2010 to December 2015 after informed consents obtained.The diagnosis of CP was established based on the findings of computed tomography, magnetic resonance imaging, or endoscopic ultrasound, in accordance with the Asia-Pacific consensus.

Sampling Method

Non-Probability Sample

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

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided