Gallstones and Risk of Inflammatory Bowel Disease

NCT05882006 | Completed

• 1 other identifier: IBD Risk of Gallstones
• Study Type: observational
• Target: 5,035
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study was to evaluate the association between gallstone disease and the risk of inflammatory bowel disease.

Conditions

Inflammatory Bowel Diseases

Keywords

Gallstone; Crohn's disease; ulcerative colitis

Outcome Measures

Primary Outcomes (2)

• The prevalence of gallstone disease among patients with or without IBD

  We assess the prevalence as the number of gallstone diseases divided by the number of IBD patients or non-IBD patients. Gallstone disease was diagnosed as presence of gallstones, cholecystectomy, choledocholithotomy and Endoscopic Retrograde Cholangio-Pancreatography (ERCP).

  10 years

• The odds ratio of the association between the presence of gallstone disease and risk of inflammatory bowel disease

  The odds ratio is a ratio of two sets of odds: the odds in case group (gallstone diseases with IBD divided by non-gallstone disease with IBD) versus the odds in control group (gallstone diseases without IBD divided by non-gallstone disease without IBD). Finally, we can calculate the odds ratio by dividing the ratio of the case group by the ratio of the control group.

  10 years

Study Arms (2)

cases

IBD patients (including Crohn's disease and Ulcerative colitis)

Other: gallstones

controls

Age, sex, and calendar-year matched controls sampled from non-IBD patients to be a round number of at least four times the number of cases

Other: gallstones

Interventions

gallstones OTHER

fellow up if the patients have gallstones

cases; controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

IBD patients

You may qualify if:

• Age between 18 and 90 years old
• IBD established by standard criteria, either Crohn's disease or ulcerative colitis

You may not qualify if:

• Pregnant or nursing woman;
• Prior abdominal surgery related to IBD, such as subtotal or total colectomy;
• Post organ transplant patients;
• Patients suffering from cancer currently or in the past;
• Patients suffering from significant cardiovascular disease;
• Patients suffering from significant respiratory diseases;
• Patients suffering from any other chronic severe diseases.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead

Study Sites (4)

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730000, China

Location

Wuwei Tumor Hospital

Wuwei, Gansu, 733099, China

Location

The Seventh Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, 518107, China

Location

Related Publications (3)

• GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.

  PMID: 31648971 BACKGROUND

• Lammert F, Gurusamy K, Ko CW, Miquel JF, Mendez-Sanchez N, Portincasa P, van Erpecum KJ, van Laarhoven CJ, Wang DQ. Gallstones. Nat Rev Dis Primers. 2016 Apr 28;2:16024. doi: 10.1038/nrdp.2016.24.

  PMID: 27121416 BACKGROUND

• Mi N, Yang M, Wei L, Nie P, Zhan S, Nguyen LH, Smith FG, Acharjee A, Liu X, Huang J, Xia B, Yuan J, Meng W. Gallstone Disease Is Associated With an Increased Risk of Inflammatory Bowel Disease: Results From 3 Prospective Cohort Studies. Am J Gastroenterol. 2025 Jan 1;120(1):204-212. doi: 10.14309/ajg.0000000000003111. Epub 2024 Oct 4.

  PMID: 39364876 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Gallstones; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Cholelithiasis; Biliary Tract Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colitis; Colonic Diseases

Study Officials

• Wenbo Meng, M.D.

  Hepatopancreatobiliary Surgery Institute of Gansu Province

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: May 21, 2023
• Primary Completion: November 16, 2024
• Study Completion: November 16, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (4)