The Course of Acute Pancreatitis in Patients With Different BMI Groups

NCT04901949 | Completed

• 1 other identifier: Aa654321+
• Study Type: observational
• Target: 1,334
• Locations: 1 country
• Sites: 1

Brief Summary

In obese (OB) patients, the presence of an increased inflammatory state in the body due to the increase in abdominal adipose tissue and increase in the frequency of gallstones and lipid levels are expected to increase the development of acute pancreatitis (AP). The effect of obesity on the clinical course of acute pancreatitis has much been attracted the attention of researchers. The aim of this study is to evaluate whether the prevalence and severity of AP, as well as Balthazar tomographic scoring, differs in BMI groups (normal, overweight, obese).

Conditions

Acute Pancreatitis; Obesity; Body Weight

Keywords

Acute pancreatitis; Obesity; Body Mass Index; Revised Atlanta Scoring; Balthazar Scoring

Outcome Measures

Primary Outcomes (2)

• The course of acute pancreatitis (mild, moderate, and severe) will be evaluated in patients with different body mass index groups.

  The course of acute pancreatitis is defined as mild (no organ insufficiency and local complications), moderate (presence of local complications +/- transient organ insufficiency less than \<48h), and severe (permanent organ insufficiency longer than 48h) according to the revised Atlanta scoring. Body mass index is calculated by dividing the weight of a patient (as a kilogram) by the height (as a square meter). Normal weighted patients form Group 1 (≤24,9 kg/m2), overweighted patients form Group 2 (25-30 kg/m2), and obese patients form Group 3 (≥30,1 kg/m2).

  Within a month

• Efficacy of acute pancreatitis tomographic scoring (Balthazar) in different body mass index groups

  Does the course of acute pancreatitis in the body mass index groups (Group 1, 2, and 3) show parallelism with the tomographic scoring? Whether tomographic score is successful or not in different body mass index groups?

  Within a month

Secondary Outcomes (5)

• Hospitalization days of the patients according to body mass index groups?

  Within a month

• Need for intensive care unit hospitalization

  Within a month

• Did the patient lose his life due to AP?

  Within a month

• Whether interventional procedures such as endosonography or endoscopic retrograde cholangiopancreatography are required due to the patient's disease

  Within a month

• How many times has the patient had an acute pancreatitis attack?

  Through study completion, an average of 1 year

Study Arms (3)

BMI Group 1

If BMI is less than 24,9 kg/m2

BMI Group 2

If BMI is between 25 - 30 kg/m2

BMI group 3

If BMI is more than 30,1 kg/m2

Eligibility Criteria

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

Study Population

Patients with a diagnosis of acute pancreatitis.

You may qualify if:

• Patients with acute pancreatitis diagnosis according to the revised Atlanta criteria.

You may not qualify if:

• Patients who sign a treatment rejection form immediately after admission to the hospital and leave the hospital,
• Psychiatric patients
• Patients with very poor general conditions will not be included in the study.

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University, Gastroenterology Clinic

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

• Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

  PMID: 23100216 RESULT

• Khatua B, El-Kurdi B, Singh VP. Obesity and pancreatitis. Curr Opin Gastroenterol. 2017 Sep;33(5):374-382. doi: 10.1097/MOG.0000000000000386.

  PMID: 28719397 RESULT

• Shin KY, Lee WS, Chung DW, Heo J, Jung MK, Tak WY, Kweon YO, Cho CM. Influence of obesity on the severity and clinical outcome of acute pancreatitis. Gut Liver. 2011 Sep;5(3):335-9. doi: 10.5009/gnl.2011.5.3.335. Epub 2011 Aug 18.

  PMID: 21927663 RESULT

Related Links

• Prevalence of overweight among adults, BMI \>= 25 (age-standardized estimate) (%)
• Prevalence of obesity among adults, BMI \>= 30 (crude estimate) (%)

MeSH Terms

Conditions

Pancreatitis; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali̇ Tüzün Ince

  Bezmialem Vakif Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 26, 2021
• Study Start: September 20, 2020
• Primary Completion: April 1, 2021
• Study Completion: April 30, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)