Acute Gallstone PancreatitisNCT05498961
The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis
An observational study of Acute Gallstone Pancreatitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP) Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Gallstone Pancreatitis
- What is being tested?
- Gallstone characteristics
- How many people
- 301 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 24 Sep 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute gallstone pancreatitis patients
Who may be able to join
- Acute gallstone pancreatitis (GSP) patients.
Who cannot join
- Pancreatitis with bile duct stones, trauma, drugs, and surgery;
- Recurrent gallstone pancreatitis;
- Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma;
- Previous hepatobiliary and pancreatic surgery, Organ transplantation;
- Intestinal obstruction or other obstructive diseases;
- Chronic pancreatitis or pancreatic duct stones;
- Thrombotic disease;
- Alcoholic pancreatitis and hyperlipidemia pancreatitis.
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000
About this study
Official title: The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis
The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)
Read the detailed description
The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.
- Conditions
- Acute Gallstone Pancreatitis
- Being tested
- Gallstone characteristics
- Keywords
- Pancreatitis, Gallstone, Severity
- Medical subject headings
- Pancreatitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallstone characteristicsOther
stone size, number, the thickness
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severity of GSP patients
Based on the 2012 Atlanta International Consensus, Mild acute pancreatitis (MAP) is defined as no organ failure and no local or systemic complications. Moderate to severe acute pancreatitis (MSAP) refers to patients with organ failure, local complications, or aggravated complications. Severe acute pancreatitis (SAP) is defined as persistent organ failure for more than 48 hours.
Measured: 1 month
Secondary outcomes (3)
Modified computed tomography severity index (MCTSI) score
Without knowing the prognosis, two radiologists with eight and ten years of experience independently scored the severity of GSP through the MCTSI score and reached an agreement through discussion when there was disagreement.
Measured: 1 month
Gallstone size
The diameter of the stones
Measured: 1 month
Number of stones
The number of gallstones
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start10 Aug 2022
- Primary completion24 Sep 2023
- Study completion24 Sep 2023
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 Gallstone PancreatitisStudies of the same condition, open and under way.
- 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Meng, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Wenbo Meng, M.D.,Ph.D, Principal investigator, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498961
- Sponsor's protocol ID
- acute gallstone pancreatitis
- Status last verified
- Sep 2023
- First submitted
- 10 Aug 2022
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If patients permitted
Publications
Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
PubMed 23622135Boxhoorn L, Voermans RP, Bouwense SA, Bruno MJ, Verdonk RC, Boermeester MA, van Santvoort HC, Besselink MG. Acute pancreatitis. Lancet. 2020 Sep 5;396(10252):726-734. doi: 10.1016/S0140-6736(20)31310-6.
PubMed 32891214Ma Y, Yue P, Zhang J, Yuan J, Liu Z, Chen Z, Zhang H, Zhang C, Zhang Y, Dong C, Lin Y, Liu Y, Li S, Meng W. Early prediction of acute gallstone pancreatitis severity: a novel machine learning model based on CT features and open access online prediction platform. Ann Med. 2024 Dec;56(1):2357354. doi: 10.1080/07853890.2024.2357354. Epub 2024 May 30.
PubMed 38813815
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis
- ClinicalTrials.gov ID
- NCT05498961
- Acronym / sponsor ID
- acute gallstone pancreatitis
- Conditions
- Acute Gallstone Pancreatitis
- Keywords
- Pancreatitis, Gallstone, Severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 12 Aug 2022 (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.
The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)
Detailed description
The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute gallstone pancreatitis patients
Key inclusion criteria (1 listed)
- Acute gallstone pancreatitis (GSP) patients.
Key exclusion criteria (8 listed)
- Pancreatitis with bile duct stones, trauma, drugs, and surgery;
- Recurrent gallstone pancreatitis;
- Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma;
- Previous hepatobiliary and pancreatic surgery, Organ transplantation;
- Intestinal obstruction or other obstructive diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallstone characteristicsstone size, number, the thickness | Other | – |
Primary outcome
Number of severity of GSP patients
Time frame: 1 month
Based on the 2012 Atlanta International Consensus, Mild acute pancreatitis (MAP) is defined as no organ failure and no local or systemic complications. Moderate to severe acute pancreatitis (MSAP) refers to patients with organ failure, local complications, or aggravated complications. Severe acute pancreatitis (SAP) is defined as persistent organ failure for more than 48 hours.
3 secondary outcomes
Modified computed tomography severity index (MCTSI) score
Time frame: 1 month
Gallstone size
Time frame: 1 month
Number of stones
Time frame: 1 month
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 Sep 2023.
- Background: PubMed 23622135Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
- Background: PubMed 32891214Boxhoorn L, Voermans RP, Bouwense SA, Bruno MJ, Verdonk RC, Boermeester MA, van Santvoort HC, Besselink MG. Acute pancreatitis. Lancet. 2020 Sep 5;396(10252):726-734. doi: 10.1016/S0140-6736(20)31310-6.
- Derived from this study: PubMed 38813815Ma Y, Yue P, Zhang J, Yuan J, Liu Z, Chen Z, Zhang H, Zhang C, Zhang Y, Dong C, Lin Y, Liu Y, Li S, Meng W. Early prediction of acute gallstone pancreatitis severity: a novel machine learning model based on CT features and open access online prediction platform. Ann Med. 2024 Dec;56(1):2357354. doi: 10.1080/07853890.2024.2357354. Epub 2024 May 30.
- Individual participant dataSharing planned: No. If patients permitted
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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.
Wenbo Meng, M.D.,Ph.D principal investigator
LanZhou University
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 Gallstone Pancreatitis, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
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 8 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 Sep 2023. 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 China. 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?
Number of severity of GSP patients (time frame: 1 month). 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 NCT05498961, 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 Sep 2023.