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Active, not recruitingNCT07908576Updated Nov 2, 2026

Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study

An observational study in Colorectal Adenoma, Cholecystectomy and Biliary Tract Diseases, sponsored by Nanjing First Hospital, Nanjing Medical University. Active, not recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
8,450
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Adenoma
  • Cholecystectomy
  • Biliary Tract Diseases

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In context

Biliary Tract Diseases

59 studies on the registry are indexed under Biliary Tract Diseases; 12 are open to participants now.

This study's enrollment of 8,450 is above the median of 414 across 18 observational studies indexed under Biliary Tract Diseases.

Browse Biliary Tract Diseases studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 224 studies on the registry; 110 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 and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
8,450 participants (actual)
Patient registry
No

Groups and cohorts

  • Biliary Tract Exposure Group

    Patients with a history of cholecystectomy or biliary tract-related diseases prior to or concurrent with the baseline colonoscopy.

    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.

    Other: No intervention. This is an observational study.

Interventions

  • OtherNo intervention. This is an observational study.

    No intervention. This is an observational study.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: The first colonoscopy during the study period that met the inclusion and exclusion criteria, i.e., the baseline colonoscopy.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Dec 2025, 119 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2026
First posted
Nov 2, 2026
StartActual
Jan 2016
Primary completionActual
Dec 2025
CompletionEst.
Dec 2026
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07908576
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Jan 2016
Primary completion
Dec 2025
Completion
Dec 2026 (estimated)
Last update
Nov 2, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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