The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis

Completed

• Conditions: Acute Gallstone Pancreatitis

• Registration Number: NCT05498961
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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 Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-12
• Status Verified: 2023-09
• Primary Completion: 2023-09-24
• Study Completion: 2023-09-24
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

• Acute gallstone pancreatitis (GSP) patients.

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of severity of GSP patients	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.

Secondary Outcome Measures

Name	Time	Method
Modified computed tomography severity index (MCTSI) score	1 month	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.
Gallstone size	1 month	The diameter of the stones
Number of stones	1 month	The number of gallstones

Trial Locations

Locations (1)

Hepatopancreatobiliary Surgery Institute of Gansu Province; 🇨🇳 Lanzhou, Gansu, China