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NCT07908576
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Conditions: Colorectal Adenoma, Cholecystectomy, Biliary Tract Diseases
Sex: All
Ages: 18 Years – N/A
Enrollment: 8450
Sponsor: Nanjing First Hospital, Nanjing Medical University
Summary
This study is a retrospective real-world study based on the electronic medical record database of Nanjing First Hospital. By integrating data from the hospital information system, ultrasound system, endoscopy system, pathology system, surgery and anesthesia system, medical record front pages, laboratory system, and electronic medical records, the study aims to evaluate the relationship between a history of cholecystectomy and biliary tract-related diseases and the detection risk of colorectal adenoma, and further analyze their associations with advanced lesions including advanced adenoma, high-grade intraepithelial neoplasia, adenoma carcinogenesis, or colorectal cancer. Additionally, it will explore the impact of different biliary disease subtypes, time intervals after cholecystectomy, and adenoma location on the study results. If the study finds that cholecystectomy or specific biliary diseases are associated with an increased risk of colorectal adenoma and advanced lesions, it may provide a reference for risk stratification of colorectal tumor screening and optimization of colonoscopy follow-up strategies for patients with biliary diseases; if no clear association is found, it may also provide evidence for clinically reasonable assessment of screening needs and avoidance of over-examination.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years, both sexes included.
2. At least one biliary ultrasound examination performed at this hospital during the study period.
3. At least one colonoscopy or pan-colonoscopy performed at this hospital during the study period.
4. Biliary ultrasound reports and colonoscopy reports contained key information sufficient for the determination of exposure and outcomes.
5. Reliable patient matching could be achieved through the hospital's unique identifier, visit number, examination number, etc.
6. Case data were within the data extraction timeframe and scope of use approved by the ethics committee.
Exclusion Criteria:
1. History of confirmed colorectal cancer or prior radical resection for colorectal cancer before baseline.
2. Inflammatory bowel disease, including ulcerative colitis, Crohn's disease, or unclassified inflammatory bowel disease.
3. Hereditary colorectal cancer syndromes such as familial adenomatous polyposis, Lynch syndrome, and Peutz-Jeghers syndrome.
4. History of major colorectal resection, which affects the conventional risk assessment of colorectal adenoma.
5. Colonoscopy not reaching the ileocecal valve, or poor bowel preparation with reports indicating a significant impact on observation.
6. Missing key exposure, outcome, or matching information, precluding completion of the primary analysis.
7. Records of only gastroscopy, ERCP, endoscopic ultrasound, or other non-colonoscopy examinations.
8. Other cases deemed by the investigators upon review as not meeting the study protocol.
Source: ClinicalTrials.gov (NCT07908576). StuddyBuddy aggregates publicly available trial information.