Colorectal AdenomaNCT07908576
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
An observational study of Colorectal Adenoma and Cholecystectomy, run by Nanjing First Hospital, Nanjing Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma, Cholecystectomy, Biliary Tract Diseases
- How many people
- 8,450 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study subjects were adult patients who underwent biliary ultrasound examination and concurrently underwent colonoscopy or pan-colonoscopy at Nanjing First Hospital, Nanjing Hospital of Chinese Medicine, Wuhu Hospital of Traditional Chinese Medicine, Sir Run Run Hospital Nanjing Medical University, and Yangzhou Hospital of Traditional Chinese Medicine between January 2015 and December 2025. Based on 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, cases meeting the inclusion and exclusion criteria will be screened.
Who may be able to join
- Age ≥18 years, both sexes included.
- At least one biliary ultrasound examination performed at this hospital during the study period.
- At least one colonoscopy or pan-colonoscopy performed at this hospital during the study period.
- Biliary ultrasound reports and colonoscopy reports contained key information sufficient for the determination of exposure and outcomes.
- Reliable patient matching could be achieved through the hospital's unique identifier, visit number, examination number, etc.
- Case data were within the data extraction timeframe and scope of use approved by the ethics committee.
Who cannot join
- History of confirmed colorectal cancer or prior radical resection for colorectal cancer before baseline.
- Inflammatory bowel disease, including ulcerative colitis, Crohn's disease, or unclassified inflammatory bowel disease.
- Hereditary colorectal cancer syndromes such as familial adenomatous polyposis, Lynch syndrome, and Peutz-Jeghers syndrome.
- History of major colorectal resection, which affects the conventional risk assessment of colorectal adenoma.
- Colonoscopy not reaching the ileocecal valve, or poor bowel preparation with reports indicating a significant impact on observation.
- Missing key exposure, outcome, or matching information, precluding completion of the primary analysis.
- Records of only gastroscopy, ERCP, endoscopic ultrasound, or other non-colonoscopy examinations.
- Other cases deemed by the investigators upon review as not meeting the study protocol.
About this study
Official title: Correlation Between Cholecystectomy and Biliary Tract-Related Diseases and the Risk of Colorectal Adenoma: A Retrospective Real-World Study Based on Hospital Information System Data
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.
- Conditions
- Colorectal Adenoma, Cholecystectomy, Biliary Tract Diseases
- Being tested
- No intervention. This is an observational study.
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. This is an observational study.Other
No intervention. This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Biliary Tract Exposure Group | Patients with a history of cholecystectomy or biliary tract-related diseases prior to or concurrent with the baseline colonoscopy. Receives: Other: No intervention. This is an observational study. | |
| Non-Biliary Tract Exposure Group | Patients without a history of cholecystectomy or biliary tract-related diseases prior to or concurrent with the baseline colonoscopy. Receives: Other: No intervention. This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologically confirmed detection of colorectal adenoma
The primary outcome was the pathologically confirmed detection of colorectal adenoma, including tubular adenoma, tubulovillous adenoma, villous adenoma, traditional serrated adenoma, adenoma with low-grade intraepithelial neoplasia, and adenoma with high-grade intraepithelial neoplasia.
Measured: The first colonoscopy during the study period that met the inclusion and exclusion criteria, i.e., the baseline colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startJan 2016
- Primary completionDec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,450 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908576
- Sponsor's protocol ID
- KY20260831-KS-08
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cholecystectomy and Biliary Tract-Related Diseases and the Risk of Colorectal Adenoma: A Retrospective Real-World Study Based on Hospital Information System Data
- ClinicalTrials.gov ID
- NCT07908576
- Acronym / sponsor ID
- KY20260831-KS-08
- Conditions
- Colorectal Adenoma, Cholecystectomy, Biliary Tract Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,450 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biliary Tract Exposure Group | – | Other: No intervention. This is an observational study.Patients with a history of cholecystectomy or biliary tract-related diseases prior to or concurrent with the baseline colonoscopy. |
| Non-Biliary Tract Exposure Group | – | Other: No intervention. This is an observational study.Patients without a history of cholecystectomy or biliary tract-related diseases prior to or concurrent with the baseline colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study subjects were adult patients who underwent biliary ultrasound examination and concurrently underwent colonoscopy or pan-colonoscopy at Nanjing First Hospital, Nanjing Hospital of Chinese Medicine, Wuhu Hospital of Traditional Chinese Medicine, Sir Run Run Hospital Nanjing Medical University, and Yangzhou Hospital of Traditional Chinese Medicine between January 2015 and December 2025. Based on 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, cases meeting the inclusion and exclusion criteria will be screened.
Key inclusion criteria (6 listed)
- Age ≥18 years, both sexes included.
- At least one biliary ultrasound examination performed at this hospital during the study period.
- At least one colonoscopy or pan-colonoscopy performed at this hospital during the study period.
- Biliary ultrasound reports and colonoscopy reports contained key information sufficient for the determination of exposure and outcomes.
- Reliable patient matching could be achieved through the hospital's unique identifier, visit number, examination number, etc.
Key exclusion criteria (8 listed)
- History of confirmed colorectal cancer or prior radical resection for colorectal cancer before baseline.
- Inflammatory bowel disease, including ulcerative colitis, Crohn's disease, or unclassified inflammatory bowel disease.
- Hereditary colorectal cancer syndromes such as familial adenomatous polyposis, Lynch syndrome, and Peutz-Jeghers syndrome.
- History of major colorectal resection, which affects the conventional risk assessment of colorectal adenoma.
- Colonoscopy not reaching the ileocecal valve, or poor bowel preparation with reports indicating a significant impact on observation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. This is an observational study.No intervention. This is an observational study. | Other | Biliary Tract Exposure Group, Non-Biliary Tract Exposure Group |
Primary outcome
Pathologically confirmed detection of colorectal adenoma
Time frame: The first colonoscopy during the study period that met the inclusion and exclusion criteria, i.e., the baseline colonoscopy.
The primary outcome was the pathologically confirmed detection of colorectal adenoma, including tubular adenoma, tubulovillous adenoma, villous adenoma, traditional serrated adenoma, adenoma with low-grade intraepithelial neoplasia, and adenoma with high-grade intraepithelial neoplasia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenoma and Cholecystectomy, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologically confirmed detection of colorectal adenoma (time frame: The first colonoscopy during the study period that met the inclusion and exclusion criteria, i.e., the baseline colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.