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CompletedNCT05882006Updated Nov 19, 2024

Gallstones and Risk of Inflammatory Bowel Disease

An observational study in Inflammatory Bowel Diseases, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 4 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-19.

Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
5,035
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the detailed description

Crohn's disease and ulcerative colitis , collectively known as inflammatory bowel diseases , have increased substantially over the past few decades affecting nearly 6.8 million individuals worldwide. The etiology of IBD remains obscure, possibly involving a complex interaction between the genetic, environmental or microbial factors and the immune responses. Gallstone disease is one of the most common and costly gastroenterological disorders, with a prevalence of 10-20% in Europe and America. Considering that gallstones and IBD also share specific risk factors, such as obesity, inappropriate diet and metabolic hormone levels, and have the pathophysiologic linkage, such as changes in gut microbiota composition and bile acid profile, the investigators propose that the occurrence of gallstones may predict the subsequence risk of IBD. However, investigations concerning the association is lacking.

02

Conditions studied

  • Inflammatory Bowel Diseases

Keywords

  • Gallstone
  • Crohn's disease
  • ulcerative colitis
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In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's enrollment of 5,035 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 41 studies on the registry; 8 are open to participants now.

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

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Who can participate

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

Study population

IBD patients

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing woman;
  • Prior abdominal surgery related to IBD, such as subtotal or total colectomy;
  • HIV infection or any congenital immunodeficiency at the time of inclusion;
  • 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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
5,035 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Othergallstones

    fellow up if the patients have gallstones

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 10 years

  2. 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.

    Time frame: 10 years

07

Study locations

4 sites
  • Hepatopancreatobiliary Surgery Institute of Gansu Province
    Lanzhou, Gansu 730000, China
  • Lanzhou University Second Hospital
    Lanzhou, Gansu 730000, China
  • Wuwei Tumor Hospital
    Wuwei, Gansu 733099, China
  • The Seventh Affiliated Hospital, Sun Yat-Sen University
    Shenzhen, Guangdong 518107, China
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References and documents

Publications

  • 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. PubMed 31648971 ↗
  • 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. PubMed 27121416 ↗

Individual participant data

Plan to share: Undecided — After completed

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05882006
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible party
Wenbo Meng (Director of Surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province) — Principal investigator
First posted
May 31, 2023
Start date
May 21, 2023
Primary completion
Nov 16, 2024
Completion
Nov 16, 2024
Last update
Nov 19, 2024

Study contacts

Wenbo Meng, M.D.
study chair · Hepatopancreatobiliary Surgery Institute of Gansu Province

Oversight

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

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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