Cholecystectomy as a risk factor for colorectal cancer: a meta-analysis.
F D Reid, P M Mercer, M harrison...
https://pubmed.ncbi.nlm.nih.gov/8658039Actively Recruiting
Age: 21Years - 80Years
All Genders
ID05689255
A Prospective Cohort Study of Gut Microbiome and Metabolome Changes in Patients With Gallstone Disease After Surgical and Endoscopic Treatments
Led by Changi General Hospital · Updated on 2026-04-09
65
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying changes in the gut microbiome and systemic metabolome in patients with symptomatic gallbladder stones, with or without bile duct stones, who will undergo gallbladder removal surgery (cholecystectomy) and possibly endoscopic procedures like ERCP-ES. This observational study aims to see if there are differences in gut microbiome diversity and metabolome profiles before and after surgery, and how these profiles change over time. Participants will provide stool, urine, plasma, and saliva samples before surgery and again between 1 to 6 months after cholecystectomy. Patients who have bile duct stones and undergo ERCP-ES before surgery will also have bile samples collected during the procedure and surgery. Clinical data and biospecimens will be analyzed to assess microbiome and metabolome changes, comparing results to matched control groups and patients with longer-term post-surgery duration. During follow-up clinic visits 1 to 6 months after surgery, patients will be evaluated for symptoms like post-cholecystectomy syndrome or diarrhea. Researchers will perform metagenomic sequencing and metabolomic analysis on collected samples to measure gut and bile microbiome profiles and systemic metabolome changes. The study duration allows for monitoring changes over several months after surgery to better understand the impact of these interventions.
CONDITIONS
Brief Title
Gut Microbiome and Metabolome in Patients With Gallstone Disease After Surgical and Endoscopic Interventions
Who Can Participate
Age: 21Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 21 years to 80 years
- Diagnosed with symptomatic gallstone disease with or without bile duct stones confirmed by imaging such as ultrasound, CT, MRI, or endoscopic ultrasound
- Scheduled for gallbladder removal surgery (cholecystectomy) with or without prior endoscopic sphincterotomy (ERCP-ES)
- Willing to provide informed consent before joining the study
You will not qualify if you...
- Undergoing ERCP-ES without planned future gallbladder removal surgery
- Use of antibiotics or probiotics within 1 month before enrollment, except antibiotics within 48 hours before surgery or ERCP
- Diagnosis of cancer within the past year
- Previous surgeries including gastrectomy, appendectomy, or bowel surgery
- Having inflammatory bowel disease
- Active infections in the gastrointestinal tract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to surgery date after enrollment
Baseline clinical characteristics are recorded and biospecimens (stool, urine, plasma, saliva) are collected prior to cholecystectomy for gut microbiome and systemic metabolome analysis. For those undergoing ERCP-ES before surgery, bile specimens are collected during ERCP-ES and cholecystectomy.
1 baseline visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo cholecystectomy with or without prior ERCP-ES and bile duct stone extraction as part of their clinical care.
1 surgical procedure visit
Post-operative Follow-up
Duration - 1 to 6 months post-surgery
Participants are monitored during scheduled clinic reviews 1 to 6 months after surgery to assess symptoms of post cholecystectomy syndrome or diarrhea, with biospecimen collections (stool, urine, plasma, saliva) for microbiome and metabolome analysis.
1 to 2 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Changi General Hospital
Singapore, Singapore, Singapore, 529889
Actively Recruiting
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Research Team
S
Seok Hwee Koo
N
Nway Nway Aye
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Cholecystectomy and risk of metabolic syndrome.
Agostino Di Ciaula, Gabriella Garruti, David Q-H Wang...
https://pubmed.ncbi.nlm.nih.gov/29706426Cholecystectomy as a risk factor of metabolic syndrome: from epidemiologic clues to biochemical mechanisms.
Yongsheng Chen, Shuodong Wu, Yu Tian
https://pubmed.ncbi.nlm.nih.gov/28892095The Association Between Cholecystectomy, Metabolic Syndrome, and Nonalcoholic Fatty Liver Disease: A Population-Based Study.
Carmen S S Latenstein, Louise J M Alferink, Sarwa Darwish Murad...
https://pubmed.ncbi.nlm.nih.gov/32352682