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CompletedNCT05498961Updated Sep 26, 2023

The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis

An observational study in Acute Gallstone Pancreatitis, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
301
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Gallstone Pancreatitis

Keywords

  • Pancreatitis
  • Gallstone
  • Severity
03

In context

Pancreatitis

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

This study's enrollment of 301 is above the median of 179 across 282 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Acute gallstone pancreatitis patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute gallstone pancreatitis (GSP) patients.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
301 participants (actual)
Patient registry
No

Interventions

  • OtherGallstone characteristics

    stone size, number, the thickness

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

Secondary outcomes

  1. 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.

    Time frame: 1 month

  2. Gallstone size

    The diameter of the stones

    Time frame: 1 month

  3. Number of stones

    The number of gallstones

    Time frame: 1 month

07

Study locations

1 site
  • Hepatopancreatobiliary Surgery Institute of Gansu Province
    Lanzhou, Gansu 730000, China
08

References and documents

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 23622135 ↗
  • Boxhoorn 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 32891214 ↗
  • Ma 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 ↗

Individual participant data

Plan to share: No — If patients permitted

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Sep 2023, 13 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2022
First posted
Aug 12, 2022
StartActual
Aug 10, 2022
Primary completionActual
Sep 24, 2023
CompletionActual
Sep 24, 2023
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05498961
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible party
Wenbo Meng (Professor of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province) — Principal investigator
First posted
Aug 12, 2022
Start date
Aug 10, 2022
Primary completion
Sep 24, 2023
Completion
Sep 24, 2023
Last update
Sep 26, 2023

Study contacts

Wenbo Meng, M.D.,Ph.D
principal investigator · LanZhou University

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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