NCT05498961

Brief Summary

The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

August 10, 2022

Last Update Submit

September 24, 2023

Conditions

Keywords

PancreatitisGallstoneSeverity

Outcome Measures

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.

    1 month

Secondary Outcomes (3)

  • Modified computed tomography severity index (MCTSI) score

    1 month

  • Gallstone size

    1 month

  • Number of stones

    1 month

Interventions

stone size, number, the thickness

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute gallstone pancreatitis patients

You may qualify if:

  • Acute gallstone pancreatitis (GSP) patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Related Publications (3)

  • 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.

    PMID: 23622135BACKGROUND
  • 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.

    PMID: 32891214BACKGROUND
  • 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.

MeSH Terms

Conditions

PancreatitisGallstones

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesCholelithiasisBiliary Tract DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Wenbo Meng, M.D.,Ph.D

    LanZhou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of surgery

Study Record Dates

First Submitted

August 10, 2022

First Posted

August 12, 2022

Study Start

August 10, 2022

Primary Completion

September 24, 2023

Study Completion

September 24, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

If patients permitted

Locations