Identification of the Impact of Acute Pancreatitis on Quality of Life

NCT04222075 | Unknown

• 1 other identifier: WD-2018APQOL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis; Quality of Life

Keywords

Acute Pancreatitis; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  1 month

• 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.

  3 months

• 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.

  6 months

• 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.

  12 months

Secondary Outcomes (4)

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

  1 month

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

  3 months

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

  6 months

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

  12 months

Study Arms (1)

Acute Pancreatitis

Patients after acute pancreatitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 25333403 BACKGROUND

• 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.

  PMID: 28579182 BACKGROUND

• Ding H, Dai J, Lin J, Gong L, Sun H, Song K, Xie F, Wu D. A 12-month follow-up study of discharged patients with acute pancreatitis: An acute condition with prolonged sequela. Chin Med J (Engl). 2024 Jan 20;137(2):250-252. doi: 10.1097/CM9.0000000000002847. Epub 2023 Sep 5. No abstract available.

  PMID: 37668021 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• DONG WU, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DONG WU, MD

CONTACT

8618612671010; dongwu@pumc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 9, 2020
• Study Start: August 26, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

CN (1)