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Status unknownNCT04222075Updated Jan 9, 2020

Identification of the Impact of Acute Pancreatitis on Quality of Life

An observational study in Acute Pancreatitis and Quality of Life, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2020-01-09.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Pancreatitis
  • Quality of Life

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Keywords

  • Acute Pancreatitis
  • Quality of Life
03

In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 200 is above the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients admitted to Peking Union Medical College Hospital with a diagnosis of acute pancreatitis

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Acute Pancreatitis

    Patients after acute pancreatitis

06

What researchers measure

Primary outcomes

  1. Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (One-month follow-up after discharge)

    Onemonth follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Chinese Time-Trade Off value sets will be adopted to transform the descriptive system into health value (-0.149 to 1). The higher health value indicates the better health status.

    Time frame: 1 month

  2. Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Three-month follow-up after discharge)

    Three-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Chinese Time-Trade Off value sets will be adopted to transform the descriptive system into health value (-0.149 to 1). The higher health value indicates the better health status.

    Time frame: 3 months

  3. Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Six-month follow-up after discharge)

    Six-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Chinese Time-Trade Off value sets will be adopted to transform the descriptive system into health value (-0.149 to 1). The higher health value indicates the better health status.

    Time frame: 6 months

  4. Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level questionnaire (Twelve-month follow-up after discharge)

    Twelve-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Chinese Time-Trade Off value sets will be adopted to transform the descriptive system into health value (-0.149 to 1). The higher health value indicates the better health status.

    Time frame: 12 months

Secondary outcomes

  1. Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (One-month follow-up after discharge)

    One-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (SF-36), which is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Time frame: 1 month

  2. Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Three-month follow-up after discharge)

    Three-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (SF-36), which is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Time frame: 3 months

  3. Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Six-month follow-up after discharge)

    Six-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (SF-36), which is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Time frame: 6 months

  4. Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (Twelve-month follow-up after discharge)

    Twelve-month follow-up after discharge: Quality of life of patients after acute pancreatitis will be assessed by 36-Item Short-form health survey (SF-36), which is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    • Dong Wu, M.D. · Contact
    Recruiting
08

References and documents

Publications

  • 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. PubMed 25333403 ↗
  • 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. PubMed 28579182 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04222075
Lead sponsor
Peking Union Medical College Hospital
Responsible party
DONG WU (Associate Professor of Gastroenterology, Peking Union Medical College Hospital) — Principal investigator
First posted
Jan 9, 2020
Start date
Aug 26, 2018
Primary completion
Sep 1, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Jan 9, 2020

Study contacts

DONG WU, MD
Contact
dongwu@pumc.edu.cn
8618612671010
DONG WU, MD
principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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