Clinical trial NCT04222075: Identification of the Impact of Acute Pancreatitis on Quality of Life
Official title: Identification of the Impact of Acute Pancreatitis on Quality of Life in Discharged Chinese Patients: a One-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Pancreatitis
Quality of Life
Keywords: Acute Pancreatitis
Quality of Life
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to Peking Union Medical College Hospital with a diagnosis of acute pancreatitis

Brief summary: In abdomen, the pancreas as a gland is involved in the digestive and endocrine system by secreting digestive enzymes and insulin. Acute pancreatitis (AP) is a common inflammatory condition of the pancreas with symptoms of sudden abdominal pain and high temperature which may develop to severe complications in some patients. The incidence of AP was roughly 33.74 cases per 100, 000 person-years around the world but varies in different regions which America has the highest incidence of 58.20 cases per 100 000 person-years. There are very few studies published on AP in China, while Japanese national survey in 2011 estimated an incidence rate of 49.4 per 100,000 population and a study in Taiwan showed an annual average incidence of 36.9 per 100,000 persons with a slight change over ten years.

In most cases, patient with AP will start to recover within a week, but the patient quality of life (QoL) is still a big concern for disease management. It quantitatively measures the physical, mental and social wellbeing of individuals or their life satisfaction by questionnaires or surveys. Although very few studies have demonstrated the effect of AP on patient QoL, there is accumulating evidence to show its importance. Some studies reported no differences in QoL between AP patients and age-matched healthy people, whereas others showed QoL was significantly impaired due to AP. A large population-based follow-up study is needed to evaluate the impact of acute pancreatitis on quality of life. In addition, as the population investigated in most research was European based, the QoL evaluation of patients after AP among the Chinese population is also essential.


Eligibility criteria: Inclusion Criteria:

* Acute pancreatitis.
* Must be able to response an online survey.

Exclusion Criteria:

• N/A

Primary outcomes:
measure: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (One-month follow-up after discharge)
timeFrame: 1 month
measure: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Three-month follow-up after discharge)
timeFrame: 3 months
measure: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Six-month follow-up after discharge)
timeFrame: 6 months
measure: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Twelve-month follow-up after discharge)
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (One-month follow-up after discharge)
timeFrame: 1 month
measure: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Three-month follow-up after discharge)
timeFrame: 3 months
measure: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Six-month follow-up after discharge)
timeFrame: 6 months
measure: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Twelve-month follow-up after discharge)
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: DONG WU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pendharkar SA, Salt K, Plank LD, Windsor JA, Petrov MS. Quality of life after acute pancreatitis: a systematic review and meta-analysis. Pancreas. 2014 Nov;43(8):1194-200. doi: 10.1097/MPA.0000000000000189.
citation: Machicado JD, Gougol A, Stello K, Tang G, Park Y, Slivka A, Whitcomb DC, Yadav D, Papachristou GI. Acute Pancreatitis Has a Long-term Deleterious Effect on Physical Health Related Quality of Life. Clin Gastroenterol Hepatol. 2017 Sep;15(9):1435-1443.e2. doi: 10.1016/j.cgh.2017.05.037. Epub 2017 Jun 1.