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Patient-reported Outcome Scale in Acute Pancreatitis (PAN-PROMISE)

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ClinicalTrials.gov Identifier: NCT03650062
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Enrique de-Madaria, Hospital General Universitario de Alicante

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.

Condition or disease
Acute Pancreatitis

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Study Type : Observational [Patient Registry]
Actual Enrollment : 525 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Patient-reported Outcome Scale in Acute pancreatitis-an International Prospective Cohort Study
Actual Study Start Date : May 30, 2017
Actual Primary Completion Date : February 3, 2019
Actual Study Completion Date : February 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis




Primary Outcome Measures :
  1. Severity of acute pancreatitis according to the revised Atlanta classification [incidence of local and/or systemic complications] [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    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)

  2. PAN-PROMISE patient reported outcome measurement instrument [ Time Frame: From within 24h after admission to 15 days after discharge ]

    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


Secondary Outcome Measures :
  1. EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) Version 3.0 [ Time Frame: 15 days after hospital discharge ]
    EORTC QLQ-C30, a widely used and validated quality of life scale, includes 28 questions with a four-point scale: "Not at all" (1 point), "A little" (2), "Quite a bit" (3) and "Very much." (4); 4 means an important impact on quality of life. The last 2 questions are scored from 1 (very poor) to 7 (excellent), being 7 indicative of excellent quality of life.

  2. C-reactive protein [ Time Frame: 48 and 72h after recruitment ]
    A marker of inflammation

  3. Local complications (incidence of pancreatic/peripancreatic necrosis and acute peripancreatic fluid collections) [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Defined according to the revised Atlanta classification (Banks et al, Gut 2013)

  4. Need for invasive treatment [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Endoscopic, percutaneous or surgical drainage or necrosectomy

  5. Need for nutritional support [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Need for enteral and/or parenteral nutritional support

  6. Admission in the Intensive Care Unit [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Need for intensive care support

  7. Hospital stay [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Days, on index admission

  8. Organ failure [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Transient and persistent organ failure defined according to the revised Atlanta classification (Banks et al, Gut 2013)

  9. Mortality [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Mortality during index admission

  10. Hospital readmission [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Hospital readmission due to symptom relapse or complications of index acute pancreatitis

  11. Systemic Inflammatory Response Syndrome (SIRS) [ Time Frame: Up to 15 days after hospital discharge from index hospital admission ]
    Presence of SIRS and persistent (>48h) SIRS



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients admitted with acute pancreatitis in the participating centers.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650062


Locations
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Sponsors and Collaborators
Enrique de-Madaria
Investigators
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Study Director: José Joaquín Mira, PsyD PhD Universidad Miguel Hernandez de Elche
Principal Investigator: Enrique de-Madaria, MD PhD Hospital General Universitario de Alicante
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrique de-Madaria, Principal Investigator, Hospital General Universitario de Alicante
ClinicalTrials.gov Identifier: NCT03650062    
Other Study ID Numbers: PI2016/69
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The whole database will be offered to the study collaborators who actively recruited patients
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enrique de-Madaria, Hospital General Universitario de Alicante:
Patient Reported Outcome Measures
Follow-Up Studies
Patient Outcome Assessment
Treatment Outcome
Pancreatitis, Acute Necrotizing
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases