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Completed

NCT Number: NCT05498961

The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis

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

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Key information

Conditions

Acute Gallstone Pancreatitis Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pancreatic Diseases Pancreatitis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gallstone characteristics

Other

stone size, number, the thickness

Primary outcomes

  1. 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.

Secondary outcomes

  1. Modified computed tomography severity index (MCTSI) score

    Time frame: 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.

  2. Gallstone size

    Time frame: 1 month

    The diameter of the stones

  3. Number of stones

    Time frame: 1 month

    The number of gallstones

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

The Effect of Gallstone Characteristics for the Severity of Acute Gallstone Pancreatitis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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