Endoscopic Retrograde Cholangiopancreatography | NCT07490132

Studies
Endoscopic Retrograde Cholangiopancreatography

NCT07490132

Sponsor

Methodist Health System

Status

Recruiting

Last Update Posted

Mar 24, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Gastro-Intestinal Disorder

Interventions

Patients undergoing ERCPs at Methodist Dallas Medical Center

Countries

United States

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

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2026Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Mar 18, 2026

First Submission Date that Met QC Criteria

Mar 18, 2026

First Posted Date

Mar 24, 2026Actual

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 18, 2026

Last Update Posted Date

Mar 24, 2026Actual

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

The risk of post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis(PEP) is influenced by patient and procedure-related factors. Strategies to decrease PEP(Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis) are of great importance.

Detailed Description

The primary objective of this study is to provide a mechanism to store the following information about patients undergoing ERCPs at Methodist Dallas Medical Center. This registry will be permissive of quality improvement and research studies.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

25 Years

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
Underwent ERCP		Underwent ERCP between January 1, 2000 through December 31, 2025	Other: Patients undergoing ERCPs at Methodist Dallas Medical Center

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients undergoing ERCPs at Methodist Dallas Medical Center	Other	The registry will include all patients who meet registry inclusion. Enrollment will terminate once 25 years of data are captured: January 1, 2000 through December 31, 2025.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Underwent ERCP	Patients undergoing ERCPs at Methodist Dallas Medical Center.	25 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients >15 years Included in MDI's Registry Underwent ERCP between January 1, 2000 through December 31, 2025

Exclusion Criteria:

Patients <15 years Patients in which cannulation was via a surgical anastomosis Patients in which cannulation was not attempted due to gastric outlet obstruction, the main papilla not found, or the minor papilla was not found will be excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who underwent ERCP and in MDI(Methodist Digestive Institute) registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Crystee Cooper, DHEd	Contact	214-947-1280		ClinicalResearch@mhd.com
Kavya Mankulangara	Contact	214-947-4604		ClinicalResearch@mhd.com

Overall Officials

Name	Affiliation	Role
Prashant Kedia, MD	Methodist Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center- Clinical Research Institute	Recruiting	Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of Protected Health Information or research information. Only de-identified Protected Health Information will be shared in relevant research mediums.

Types

Study Protocol

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004066	Digestive System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided