Acute PancreatitisNCT04901949
The Course of Acute Pancreatitis in Patients With Different BMI Groups
An observational study of Acute Pancreatitis and Obesity, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Obesity, Body Weight
- How many people
- 1,334 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of acute pancreatitis.
Who may be able to join
- Patients with acute pancreatitis diagnosis according to the revised Atlanta criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University, Gastroenterology Clinic
Istanbul, 34093
About this study
Official title: Comparison of the Severity and Complications of Acute Pancreatitis in Obese and Non-obese Patients According to the Atlanta and Balthazar Scores
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).
Read the detailed description
Today, the incidence of acute pancreatitis (AP) is gradually increasing. According to the Atlanta criteria, the presence of two of the three findings (characteristic abdominal pain starting from the epigastrium and spreading to the left upper quadrant in a belt manner from there, which is severe enough to bring the patient to the emergency room, amylase and lipase values being 3 of normal, radiological imaging being compatible with AP) is sufficient for the diagnosis. The disease has a mild course of 80% of patients and usually resolves within a week, but the course is severe enough to require intensive care treatment in 15-20% of patients. AP may have local (pseudocyst, abscess, necrosis, vascular thrombosis) and systemic (organ failure; lung, heart, gastrointestinal, and renal) complications.
The frequency of obesity (OB) is also increasing in societies, according to the world health organization (WHO) data, 39% of women aged ≥18 and 39% of men were overweight in 2016 in the world. Overweight and OB are defined as excessive fat accumulation that can impair health, which is an important risk factor for many chronic diseases, including diabetes, cardiovascular disease, and cancer. While once seen only as a problem in high-income countries, overweight and OB are increasing significantly in low- and middle-income countries. Body mass index (BMI) is a simple index commonly used to classify overweight and OB in adults. It is defined by dividing a person's weight by the square of their height (kg/m2). According to WHO, if the BMI is between 25-30 kg/m2, it is considered overweight, if it is ≥30,1 kg/m2, it is considered OB. An increase in the frequency of gallstones, in lipids, and in abdominal adipose tissue in OBs are expected to increase the development of AP as the cytokine and tumor necrosis factor (TNF)-α levels in the body increase. In recent years, the number of publications indicating a relationship between OB and AP frequency has been increasing.
Retrospectively, 1550 patients who followed up at the Gastroenterology Clinic of Bezmialem Vakif University between 10/2010 and 02/2020, aged ≥18 years and diagnosed with AP according to the Atlanta definition criteria were screened. After the exclusion of patients with incomplete data, 1334 patients were included in the study.
Patients' age, gender, smoking/alcohol usage, presence of diabetes/hypertension, and etiologies that cause AP and BMI were recorded.
The patients were divided into 3 groups according to their BMI;
- Group 1 (non-obese; normal) [BMI ≤ 24,9 kg/m2: n: 302: 152 ♂, 150]
- Group 2 (overweight) [BMI 25-30 kg/m2: n: 500: 262♂, 238♀]
- Group 3 (obese) [BMI> 30.1kg/m2: n: 532; 200♂, 332♀]. As of laboratory tests; Leukocyte number (n: 4.5-11x100/microliter), hematocrit (n: 35.5-48%), C reactive protein (CRP) (n: 0-5mg / dl), blood urea nitrogen (BUN) ( n: 9.8-20.1mg / dL), serum creatinine (n: 0.57-1.11mg / dl)] levels.
As of radiologic evaluation, Balthazar tomographic scoring; [scores are grouped as mild (scores 0-3), moderate (scores: 4-6), severe (scores 7-10), and scores are defined as 0:normal, 1:increase in pancreatic size, 2:inflammatory changes in pancreatic tissue, and peripancreatic fatty tissue, 3:irregularly bordered, single fluid collection, 4:irregularly circumscribed 2 or more fluid collections, with various degrees of necrosis levels between 5 and 10].
And revised Atlanta scores; A) mild AP: no organ insufficiency and local complications B) moderate AP; the presence of local complications and transient organ insufficiency (<48h) C) severe AP: permanent organ insufficiency (> 48h)] Complications (0: absent 1: local complications 2: systemic complications 3: mixed serious complications/comorbid conditions 4: infectious-sepsis) Need for the interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endosonography (EUS) Length of hospital stay (in days) Need for the intensive care unit hospitalization The number of AP attacks in the future after discharge was recorded.
Statistical Analysis
Descriptive statistics of the obtained data were calculated as Mean +/- (standard deviation) (SD), minimum, maximum, percentiles (25th, median, and 75th), and frequencies (count and percent), depending on the type of variables. The consistency and relationships between BMI groups, Balthazar scores, and Atlanta scores were analyzed using Kappa statistics and Kendall Tau-b statistics. The compliance of numerical properties to the normal distribution was examined using the Shapiro-Wilks test. One-Way ANOVA model, one of the univariate analyzes, was used to compare BMI groups and Atlanta score groups in terms of numerical features, significant differences were determined by the posthoc Tukey test. Relationships between categorical features and BMI groups and Atlanta scores were analyzed using the Pearson Chi-Square test. In addition, the combined effects of the measured features on exitus, ICU hospitalization status, and hospitalization time over 11 days were re-examined with multivariate logistic regression analysis, and in this analysis, the properties whose effects were not significant were removed from the model with the Backward variable selection method. Statistical significance level was accepted as P <= 0.05 and Statistical Package for the Social Sciences program (SPSS) (ver. 23) program was used in calculations.
- Conditions
- Acute Pancreatitis, Obesity, Body Weight
- Keywords
- Acute pancreatitis, Obesity, Body Mass Index, Revised Atlanta Scoring, Balthazar Scoring
- Medical subject headings
- Pancreatitis, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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?
Measured: Within a month
Secondary outcomes (5)
Hospitalization days of the patients according to body mass index groups?
If a patient hospitalized in the clinical ward, how many days the patients hospitalized in the clinic. Grouped as less than 10 days or more than 11 days.
Measured: Within a month
Need for intensive care unit hospitalization
If the patient has a severe course of acute pancreatitis (those with organ insufficiency lasting more than 48h. (such as lung, gastrointestinal system, kidney, etc), the patient is hospitalised into the intensive care unit. Marked as yes or no.
Measured: Within a month
Did the patient lose his life due to AP?
The patient may be alive or may be died because of the acute pancreatitis.
Measured: Within a month
Whether interventional procedures such as endosonography or endoscopic retrograde cholangiopancreatography are required due to the patient's disease
If patients have choledochal stone or cholangitis or micro stones, some interventions may needed such as endosonography or endoscopic retrograde cholangiopancreatography. Need of this procedures marked as yes or no.
Measured: Within a month
How many times has the patient had an acute pancreatitis attack?
Some patients may have several acute pancreatitis attacks; 2,3,4 etc.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start20 Sep 2020
- Primary completion1 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali̇ Tüzün Ince, Principal investigator, Bezmialem Vakif Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901949
- Sponsor's protocol ID
- Aa654321+
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23100216Khatua B, El-Kurdi B, Singh VP. Obesity and pancreatitis. Curr Opin Gastroenterol. 2017 Sep;33(5):374-382. doi: 10.1097/MOG.0000000000000386.
PubMed 28719397Shin 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.
PubMed 21927663
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Severity and Complications of Acute Pancreatitis in Obese and Non-obese Patients According to the Atlanta and Balthazar Scores
- ClinicalTrials.gov ID
- NCT04901949
- Acronym / sponsor ID
- Aa654321+
- Conditions
- Acute Pancreatitis, Obesity, Body Weight
- Keywords
- Acute pancreatitis, Obesity, Body Mass Index, Revised Atlanta Scoring, Balthazar Scoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Today, the incidence of acute pancreatitis (AP) is gradually increasing. According to the Atlanta criteria, the presence of two of the three findings (characteristic abdominal pain starting from the epigastrium and spreading to the left upper quadrant in a belt manner from there, which is severe enough to bring the patient to the emergency room, amylase and lipase values being 3 of normal, radiological imaging being compatible with AP) is sufficient for the diagnosis. The disease has a mild course of 80% of patients and usually resolves within a week, but the course is severe enough to require intensive care treatment in 15-20% of patients. AP may have local (pseudocyst, abscess, necrosis, vascular thrombosis) and systemic (organ failure; lung, heart, gastrointestinal, and renal) complications.
The frequency of obesity (OB) is also increasing in societies, according to the world health organization (WHO) data, 39% of women aged ≥18 and 39% of men were overweight in 2016 in the world. Overweight and OB are defined as excessive fat accumulation that can impair health, which is an important risk factor for many chronic diseases, including diabetes, cardiovascular disease, and cancer. While once seen only as a problem in high-income countries, overweight and OB are increasing significantly in low- and middle-income countries. Body mass index (BMI) is a simple index commonly used to classify overweight and OB in adults. It is defined by dividing a person's weight by the square of their height (kg/m2). According to WHO, if the BMI is between 25-30 kg/m2, it is considered overweight, if it is ≥30,1 kg/m2, it is considered OB. An increase in the frequency of gallstones, in lipids, and in abdominal adipose tissue in OBs are expected to increase the development of AP as the cytokine and tumor necrosis factor (TNF)-α levels in the body increase. In recent years, the number of publications indicating a relationship between OB and AP frequency has been increasing.
Retrospectively, 1550 patients who followed up at the Gastroenterology Clinic of Bezmialem Vakif University between 10/2010 and 02/2020, aged ≥18 years and diagnosed with AP according to the Atlanta definition criteria were screened. After the exclusion of patients with incomplete data, 1334 patients were included in the study.
Patients' age, gender, smoking/alcohol usage, presence of diabetes/hypertension, and etiologies that cause AP and BMI were recorded.
The patients were divided into 3 groups according to their BMI;
- Group 1 (non-obese; normal) [BMI ≤ 24,9 kg/m2: n: 302: 152 ♂, 150]
- Group 2 (overweight) [BMI 25-30 kg/m2: n: 500: 262♂, 238♀]
- Group 3 (obese) [BMI> 30.1kg/m2: n: 532; 200♂, 332♀]. As of laboratory tests; Leukocyte number (n: 4.5-11x100/microliter), hematocrit (n: 35.5-48%), C reactive protein (CRP) (n: 0-5mg / dl), blood urea nitrogen (BUN) ( n: 9.8-20.1mg / dL), serum creatinine (n: 0.57-1.11mg / dl)] levels.
As of radiologic evaluation, Balthazar tomographic scoring; [scores are grouped as mild (scores 0-3), moderate (scores: 4-6), severe (scores 7-10), and scores are defined as 0:normal, 1:increase in pancreatic size, 2:inflammatory changes in pancreatic tissue, and peripancreatic fatty tissue, 3:irregularly bordered, single fluid collection, 4:irregularly circumscribed 2 or more fluid collections, with various degrees of necrosis levels between 5 and 10].
And revised Atlanta scores; A) mild AP: no organ insufficiency and local complications B) moderate AP; the presence of local complications and transient organ insufficiency (<48h) C) severe AP: permanent organ insufficiency (> 48h)] Complications (0: absent 1: local complications 2: systemic complications 3: mixed serious complications/comorbid conditions 4: infectious-sepsis) Need for the interventional procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endosonography (EUS) Length of hospital stay (in days) Need for the intensive care unit hospitalization The number of AP attacks in the future after discharge was recorded.
Statistical Analysis
Descriptive statistics of the obtained data were calculated as Mean +/- (standard deviation) (SD), minimum, maximum, percentiles (25th, median, and 75th), and frequencies (count and percent), depending on the type of variables. The consistency and relationships between BMI groups, Balthazar scores, and Atlanta scores were analyzed using Kappa statistics and Kendall Tau-b statistics. The compliance of numerical properties to the normal distribution was examined using the Shapiro-Wilks test. One-Way ANOVA model, one of the univariate analyzes, was used to compare BMI groups and Atlanta score groups in terms of numerical features, significant differences were determined by the posthoc Tukey test. Relationships between categorical features and BMI groups and Atlanta scores were analyzed using the Pearson Chi-Square test. In addition, the combined effects of the measured features on exitus, ICU hospitalization status, and hospitalization time over 11 days were re-examined with multivariate logistic regression analysis, and in this analysis, the properties whose effects were not significant were removed from the model with the Backward variable selection method. Statistical significance level was accepted as P <= 0.05 and Statistical Package for the Social Sciences program (SPSS) (ver. 23) program was used in calculations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of acute pancreatitis.
Key inclusion criteria (1 listed)
- Patients with acute pancreatitis diagnosis according to the revised Atlanta criteria.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The course of acute pancreatitis (mild, moderate, and severe) will be evaluated in patients with different body mass index groups.
Time frame: Within a month
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).
Efficacy of acute pancreatitis tomographic scoring (Balthazar) in different body mass index groups
Time frame: Within a month
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?
5 secondary outcomes
Hospitalization days of the patients according to body mass index groups?
Time frame: Within a month
Need for intensive care unit hospitalization
Time frame: Within a month
Did the patient lose his life due to AP?
Time frame: Within a month
Whether interventional procedures such as endosonography or endoscopic retrograde cholangiopancreatography are required due to the patient's disease
Time frame: Within a month
How many times has the patient had an acute pancreatitis attack?
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Results publication: PubMed 23100216Banks 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.
- Results publication: PubMed 28719397Khatua B, El-Kurdi B, Singh VP. Obesity and pancreatitis. Curr Opin Gastroenterol. 2017 Sep;33(5):374-382. doi: 10.1097/MOG.0000000000000386.
- Results publication: PubMed 21927663Shin 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.
- Prevalence of overweight among adults, BMI \>= 25 (age-standardized estimate) (%)Link provided by the sponsor.
- Prevalence of obesity among adults, BMI \>= 30 (crude estimate) (%)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali̇ Tüzün Ince principal investigator
Bezmialem Vakif Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis and Obesity, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The course of acute pancreatitis (mild, moderate, and severe) will be evaluated in patients with different body mass index groups. (time frame: Within a month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.