NCT04214756

Brief Summary

The overall goal of this ongoing registry study is to optimize initial evaluation and treatment of patients with AP according to recommended guidelines, the Methodist Acute Pancreatitis Protocol (MAPP), which were implemented in January 2015.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2014

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

12 years

First QC Date

August 12, 2019

Last Update Submit

March 18, 2026

Conditions

Acute Pancreatitis (AP)

Outcome Measures

Primary Outcomes (4)

  • Length of Hospital Stay

    Length of hospital stay will be calculated in days with a discrete variable as \[(discharge date - Admission date)\].

    From April 2016 until Jun 2025 (anticipated study close)

  • Ward days

    Length of ward days will be calculated in days with a discrete variable as \[(discharge date from ward - Admission date to the ward)\].

    From April 2016 until Jun 2025 (anticipated study close)

  • ICU days

    Length of ICU stay will be calculated in days with a discrete variable as \[(discharge date from ICU - Admission date to the ICU)\].

    From April 2016 until Jun 2025 (anticipated study close)

  • Discharge status

    will be recorded as a categorical variable indicating whether the discharge was to the home, SNF or rehab facility (1=Home; 2 = SNF; 3 = Rehab)

    From April 2016 until Jun 2025 (anticipated study close)

Secondary Outcomes (8)

  • CT scan

    From April 2016 until Jun 2025 (anticipated study close)

  • Empiric antibiotics

    From April 2016 until Jun 2025 (anticipated study close)

  • Harmless AP score (HAPS)

    From April 2016 until Jun 2025 (anticipated study close)

  • bedside index for severity in AP (BISAP)

    From April 2016 until Jun 2025 (anticipated study close)

  • C reactive protein

    From April 2016 until Jun 2025 (anticipated study close)

  • +3 more secondary outcomes

Study Arms (2)

Patients treated pre-MAPP

The registry will collect data on all AP patients since August 2011, and will continue until a sufficient number of cases are obtained to reach statistical significance

Patients treated post-MAPP

The registry will collect data on all AP patients since August 2011, and will continue until a sufficient number of cases are obtained to reach statistical significance

Procedure: Acute Pancreatitis

Interventions

Acute PancreatitisPROCEDURE

All patients diagnosed with acute pancreatitis beginning August 2011 at MDMC, MCMC, MMMC, and MRMC will be included in the registry for analysis of baseline and clinical outcomes data and subsequently divided into two groups (i.e. those treated pre-MAPP and post-MAPP).

Patients treated post-MAPP

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with acute pancreatitis beginning August 2011 at MDMC, MCMC, MMMC, and MRMC will be included in the registry for analysis of baseline and clinical outcomes data and subsequently divided into two groups (i.e. those treated pre-MAPP and post-MAPP).

You may qualify if:

  • Age ≥ 18 years
  • Presented to ER with Acute severe pain for \< 48 hours before presentation.
  • Laboratory values of Lipase and/or amylase \> 3X normal

You may not qualify if:

  • History of recent penetrating or blunt abdominal trauma
  • Patients transferred to MDMC for upper abdominal pain consistent with pancreatic etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Paul Tarnasky, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

January 2, 2020

Study Start

April 5, 2014

Primary Completion

April 5, 2026

Study Completion

June 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)