Brief Summary

The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP) based in the patient´s experience. PAN-PROMISE is a cohort study involving patients with AP. The patient´s symptom perception will be compared with the opinion of the clinicians and with clinical outcomes.

Trial Health

On Track

Trial Health Score

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

Enrollment

525

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2017

Geographic Reach

14 countries

26 active sites

Status

completed

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

1.7 years study duration

Study Start

First participant enrolled

May 30, 2017

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2018

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2019

Completed

Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

August 20, 2018

Last Update Submit

February 3, 2019

Conditions

Acute Pancreatitis

Keywords

Patient Reported Outcome MeasuresFollow-Up StudiesPatient Outcome AssessmentTreatment OutcomePancreatitis, Acute Necrotizing

Outcome Measures

Primary Outcomes (2)

Severity of acute pancreatitis according to the revised Atlanta classification [incidence of local and/or systemic complications]
Mild acute pancreatitis (no complications), moderately severe acute pancreatitis (local complications and/or transient (≤48h) organ failure and/or exacerbation of previous comorbidity), severe acute pancreatitis (persistent (\>48h) organ failure) (see revised Atlanta classification, Banks et al, Gut 2013)
Up to 15 days after hospital discharge from index hospital admission
PAN-PROMISE patient reported outcome measurement instrument
PROMISE SCALE (Patient-reported Outcome Scale in Acute pancreatitis) Each item is scored from 0 to 10 ( worst score in the last 24h): 0 none, 10: the highest possible intensity according to the patient 1. Pain, especially in the abdomen, chest or back 2. Abdominal distention (bloating, sensation of excess gas) 3. Difficulty eating, sensation of food being stuck in the stomach 4. Difficulty with bowel movements (constipation or straining on bowel movements) 5. Nausea and/or vomiting 6. Thirst 7. Weakness, lack of energy, fatigue, difficulty moving
From within 24h after admission to 15 days after discharge

Secondary Outcomes (11)

EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) Version 3.0
15 days after hospital discharge
C-reactive protein
48 and 72h after recruitment
Local complications (incidence of pancreatic/peripancreatic necrosis and acute peripancreatic fluid collections)
Up to 15 days after hospital discharge from index hospital admission
Need for invasive treatment
Up to 15 days after hospital discharge from index hospital admission
Need for nutritional support
Up to 15 days after hospital discharge from index hospital admission
+6 more secondary outcomes

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Consecutive patients admitted with acute pancreatitis in the participating centers.

You may qualify if:

Patients ≥18 and \<80 years.
Karnofsky performance status previous to AP 100 (normal, no complaints, no evidence of disease), 90 (able to carry on normal activity; minor signs or symptoms of disease) or 80 (normal activity with effort; some signs or symptoms of disease).
Acute pancreatitis defined as at least 2 of the following 3 criteria: A) Typical abdominal pain, B) Elevation of amylase and/or lipase more than 3 times the upper limit of normality, and C) Imaging (preferably CT and/or MR) compatible with AP.
Written informed consent.

You may not qualify if:

Time between onset of symptoms and presentation in the emergency room (ER) greater than 48 hours (we do not consider as onset of symptoms previous self-limited heraldic biliary pain)
Recruitment \>24h after presentation in the ER
Karnofsky performance status previous to AP 70 (Cares for self; unable to carry on normal activity or to do active work) or less
Inability to express or understand the instructions of the study (severe congenital or acquired intellectual deficit).
More than 1 previous episode of AP.
Chronic pancreatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Enrique de-Madarialead

Study Sites (26)

Johns Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Hospital Universitario San Ignacio

Bogotá, Colombia

Location

Attikon University Hospital

Athens, Greece

Location

Centre for Translational Medicine, University of Pécs

Pécs, Hungary

Location

University of Szeged

Szeged, Hungary

Location

Dip.Medicina-Università degli Studi di Verona

Verona, Italy

Location

Vilnius University

Vilnius, Lithuania

Location

Servicio de Cirugía General, IMSS, León

Guanajuato City, Mexico

Location

Medical University of Łódź

Lodz, Poland

Location

Fernando Fonseca Hospital

Amadora, Portugal

Location

Centro Hospitalar Tondela-Viseu

Viseu, Portugal

Location

Emergency Hospital of Bucharest

Bucharest, Romania

Location

Iuliu Hatieganu University of Medicine and Pharmacy

Cluj-Napoca, Romania

Location

Immanuel Kant Baltic Federal University

Kaliningrad, Russia

Location

Konkuk University School of Medicine

Seoul, South Korea

Location

Hospital General Universitario de Alicante

Alicante, 03550, Spain

Location

Hospital Santa María

Lleida, Spain

Location

Hospital San Pedro

Logroño, Spain

Location

Hospital Central de Asturias

Oviedo, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Spain

Location

Hospital Lozano Blesa

Zaragoza, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Medical Institute Lviv

Lviv, Ukraine

Location

Related Publications (3)

Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
PMID: 25057539BACKGROUND
Sternby H, Bolado F, Canaval-Zuleta HJ, Marra-Lopez C, Hernando-Alonso AI, Del-Val-Antonana A, Garcia-Rayado G, Rivera-Irigoin R, Grau-Garcia FJ, Oms L, Millastre-Bocos J, Pascual-Moreno I, Martinez-Ares D, Rodriguez-Oballe JA, Lopez-Serrano A, Ruiz-Rebollo ML, Viejo-Almanzor A, Gonzalez-de-la-Higuera B, Orive-Calzada A, Gomez-Anta I, Pamies-Guilabert J, Fernandez-Gutierrez-Del-Alamo F, Iranzo-Gonzalez-Cruz I, Perez-Munante ME, Esteba MD, Pardillos-Tome A, Zapater P, de-Madaria E. Determinants of Severity in Acute Pancreatitis: A Nation-wide Multicenter Prospective Cohort Study. Ann Surg. 2019 Aug;270(2):348-355. doi: 10.1097/SLA.0000000000002766.
PMID: 29672416RESULT
de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
PMID: 32245906DERIVED

MeSH Terms

Conditions

PancreatitisPancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

José Joaquín Mira, PsyD PhD
Universidad Miguel Hernandez de Elche
STUDY DIRECTOR
Enrique de-Madaria, MD PhD
Hospital General Universitario de Alicante
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Target Duration: 1 Month
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 28, 2018

Study Start

May 30, 2017

Primary Completion

February 3, 2019

Study Completion

February 3, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing: Will share
Time Frame: The database will be available after publication of the PAN-PROMISE study
Access Criteria: Collaborating researchers who recruited patients will be able to apply for access to the database. The protocol of the proposed study will be considered by the PAN-PROMISE scientific committee

Locations

IT(1)US(1)GR(1)HU(2)PT(2)KR(1)ES(10)PL(1)RO(2)UA(1)CO(1)ME(1)RU(1)LI(1)

Patient-reported Outcome Scale in Acute Pancreatitis

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations