Patient-reported Outcome Scale in Acute Pancreatitis

Completed

Conditions studied: Acute Pancreatitis

In brief

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.

Key facts

Study ID: NCT03650062
Run by: Enrique de-Madaria
People needed: 525
Starts: 2017-05-30
Expected to finish: 2019-02-03
Last updated by the study team: 2019-02-05

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

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.
Presence of diseases or conditions different from AP that may interfere with the scale: other causes of abdominal pain (especially acute cholecystitis; Note: choledocholithiasis-acute cholangitis is not an exclusion criteria), obstruction of the digestive tract (peptic pyloric stenosis, gastrointestinal anastomotic stenosis, diabetic gastroparesis, gastrointestinal neoplasia...), nausea-vomiting (brain tumor, chemotherapy...) or weakness (pre-existing anemia with Hb <9 mg/dL, heart failure or respiratory insufficiency associated with minimal effort dyspnea, or domiciliary treatment with O2, advanced neoplasms or other debilitating diseases).

Where it is running

Johns Hopkins Medical Center — Baltimore, Maryland, United States
Hospital Universitario San Ignacio — Bogotá, Colombia
Attikon University Hospital — Athens, Greece
Centre for Translational Medicine, University of Pécs — Pécs, Hungary
University of Szeged — Szeged, Hungary
Dip.Medicina-Università degli Studi di Verona — Verona, Italy
Vilnius University — Vilnius, Lithuania
Servicio de Cirugía General, IMSS, León — Guanajuato City, Mexico
Medical University of Łódź — Lodz, Poland
Fernando Fonseca Hospital — Amadora, Portugal
Centro Hospitalar Tondela-Viseu — Viseu, Portugal
Emergency Hospital of Bucharest — Bucharest, Romania
Iuliu Hatieganu University of Medicine and Pharmacy — Cluj-Napoca, Romania
Immanuel Kant Baltic Federal University — Kaliningrad, Russia
Konkuk University School of Medicine — Seoul, South Korea
Hospital General Universitario de Alicante — Alicante, Spain
Hospital Santa María — Lleida, Spain
Hospital San Pedro — Logroño, Spain
Hospital Central de Asturias — Oviedo, Spain
Complejo Hospitalario de Navarra — Pamplona, Spain
Complejo Hospitalario Universitario de Santiago — Santiago de Compostela, Spain
Hospital Clínico Universitario de Valladolid — Valladolid, Spain
Hospital Alvaro Cunqueiro — Vigo, Spain
Hospital Lozano Blesa — Zaragoza, Spain
Hospital Miguel Servet — Zaragoza, Spain

Full record on ClinicalTrials.gov

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