NCT05360797

Brief Summary

Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction. With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology. Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

March 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

Same day

First QC Date

March 26, 2022

Last Update Submit

April 29, 2022

Conditions

Acute PancreatitisHome Care

Keywords

Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • The treatment failure rate

    Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality

    30 days

Secondary Outcomes (8)

  • Relapse of abdominal pain

    30 days

  • Diet tolerance

    30 days

  • Systemic Inflammatory Response Syndrome (SIRS) Score

    4 days

  • Number of Participants who Development of Organ Failure

    4 days

  • Mortality

    30 days

  • +3 more secondary outcomes

Study Arms (3)

Outpatient

EXPERIMENTAL

The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.

Other: Outpatient

Medical home care

EXPERIMENTAL

The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.

Other: Medical home care

Hospitalization

ACTIVE COMPARATOR

The mild AP patient is hospitalized

Other: Hospitalization

Interventions

OutpatientOTHER

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.

Outpatient
Medical home careOTHER

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.

Medical home care
HospitalizationOTHER

After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI\_1) in each center.

Hospitalization

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
  • age \> 18 years, sign consent form.

You may not qualify if:

  • pregnant o breastfeeding women.
  • abdominal pain lasting \>96 horas before admission.
  • the possibility of poor oral intake for reasons other than AP.
  • Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
  • Chronic pancreatitis.
  • ASA ≥3.
  • Randomization lesser the 24 hours after randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Ince AT, Senturk H, Singh VK, Yildiz K, Danalioglu A, Cinar A, Uysal O, Kocaman O, Baysal B, Gurakar A. A randomized controlled trial of home monitoring versus hospitalization for mild non-alcoholic acute interstitial pancreatitis: a pilot study. Pancreatology. 2014 May-Jun;14(3):174-8. doi: 10.1016/j.pan.2014.02.007. Epub 2014 Mar 14.

    PMID: 24854612RESULT

  • Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

    PMID: 24054878RESULT

  • Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.

    PMID: 27007094RESULT

  • Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

    PMID: 23896955RESULT

  • Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.

    PMID: 25973947RESULT

  • Ramirez-Maldonado E, Lopez Gordo S, Pueyo EM, Sanchez-Garcia A, Mayol S, Gonzalez S, Elvira J, Memba R, Fondevila C, Jorba R. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial). Ann Surg. 2021 Aug 1;274(2):255-263. doi: 10.1097/SLA.0000000000004596.

    PMID: 33196485RESULT

  • Pando E, Alberti P, Mata R, Gomez MJ, Vidal L, Cirera A, Dopazo C, Blanco L, Gomez C, Caralt M, Balsells J, Charco R. Early Changes in Blood Urea Nitrogen (BUN) Can Predict Mortality in Acute Pancreatitis: Comparative Study between BISAP Score, APACHE-II, and Other Laboratory Markers-A Prospective Observational Study. Can J Gastroenterol Hepatol. 2021 Mar 22;2021:6643595. doi: 10.1155/2021/6643595. eCollection 2021.

    PMID: 33824864RESULT

  • Ramirez-Maldonado E, Rodrigo-Rodrigo M, Lopez Gordo S, Sanchez A, Coronado Llanos D, Sanchez R, Vaz J, Fondevila C, Jorba-Martin R; Catalan Pancreatitis Collaborative Group. Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial). BMJ Open. 2023 Jun 28;13(6):e071265. doi: 10.1136/bmjopen-2022-071265.

    PMID: 37380212DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Elena Ramírez-Maldonado, PhD

    Hospital Universitari Joan XXIII

    PRINCIPAL INVESTIGATOR

  • Rosa Jorba-Martin, PhD

    Hospital Universitari Joan XXIII

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Ramírez-Maldonado, PhD

CONTACT

977295800padibarcelona@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Ramdomized
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2022

First Posted

May 4, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 31, 2024

Last Updated

May 4, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Study protocolo will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
01/08/2022-01/01/2023
Access Criteria
Pancreatic researchers