The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+

NCT ID: NCT06165328

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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Colonoscopy is the mainstay modality of choice in colorectal cancer screening worldwide. However, the rate of colonoscopy for colorectal cancer screening is very low (approximately 5-10%) because of the limited local medical resources (such as endoscopists and regional endoscope). This observational diagnostic test study aims to compare the diagnostic yield of routine computed tomography and colonoscopy in detecting colorectal tumors in patients at risk of colorectal cancer (aged more than 50 years and FIT+). The main question\[s\] it aims to answer are:

1. To compare the diagnostic yield between the routine computed tomography and colonoscopy.
2. To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.

Detailed Description

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All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day

Conditions

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Patients at Risk of Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort1

Patients with aged more than 50 years and had FIT test +

CT and colonoscopy

Intervention Type DIAGNOSTIC_TEST

All patients were admitted and worked up as inpatient cases. A blood test was obtained and a CT whole abdomen was performed for all patients in the evening. On the next day, all patients were prescribed for bowel preparation in the morning, then subsequently underwent colonoscopy in the afternoon.

Interventions

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CT and colonoscopy

All patients were admitted and worked up as inpatient cases. A blood test was obtained and a CT whole abdomen was performed for all patients in the evening. On the next day, all patients were prescribed for bowel preparation in the morning, then subsequently underwent colonoscopy in the afternoon.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Fit test +
2. Normal platelet count and normal result of PT, PTT

Exclusion Criteria

1. pregnancy or lactation
2. uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
3. recent coronary artery disease within 3 months
4. eGFR lesser than 30 mL/min/1.73m2
5. hemophilia or uncontrolled or uncorrected coagulopathy
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HatYai Hospital

OTHER

Sponsor Role collaborator

Hat Yai Medical Education Center

OTHER

Sponsor Role lead

Responsible Party

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Arunchai Chang

Head of Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arunchai Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital

Locations

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Hatyai Hospital

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Arunchai Chang, MD

Role: CONTACT

+66650979414

Araya Kaimook, MD

Role: CONTACT

+66815424454

Facility Contacts

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Arunchai Chang, MD

Role: primary

+66650979414

References

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Shaukat A, Levin TR. Current and future colorectal cancer screening strategies. Nat Rev Gastroenterol Hepatol. 2022 Aug;19(8):521-531. doi: 10.1038/s41575-022-00612-y. Epub 2022 May 3.

Reference Type RESULT
PMID: 35505243 (View on PubMed)

Wong MCS, Chan FKL. Colorectal cancer screening in middle eastern countries: Current status and future strategies to enhance screening. Saudi J Gastroenterol. 2019 Jan-Feb;25(1):1-2. doi: 10.4103/sjg.SJG_611_18. No abstract available.

Reference Type RESULT
PMID: 30665995 (View on PubMed)

Tanaka H, Oka S, Shiotani A, Sugimoto M, Suzuki H, Naito Y, Handa O, Hisamatsu T, Fukudo S, Fujishiro M, Motoya S, Yahagi N, Yamaguchi S, Chan FKL, Lee SY, Li B, Ang TL, Abdullah M, Tablante MC, Prachayakul V, Tanaka S; International Gastrointestinal Consensus Symposium Study Group. Current Status of Diagnosis and Treatment of Colorectal Cancer in Asian Countries: A Questionnaire Survey. Digestion. 2024;105(1):62-68. doi: 10.1159/000531706. Epub 2023 Jul 27.

Reference Type RESULT
PMID: 37497916 (View on PubMed)

Ganeshan A, Upponi S, Uberoi R, D'Costa H, Picking C, Bungay H. Minimal-preparation CT colon in detection of colonic cancer, the Oxford experience. Age Ageing. 2007 Jan;36(1):48-52. doi: 10.1093/ageing/afl116. Epub 2006 Nov 17.

Reference Type RESULT
PMID: 17114203 (View on PubMed)

Pilleul F, Bansac-Lamblin A, Monneuse O, Dumortier J, Milot L, Valette PJ. Water enema computed tomography: diagnostic tool in suspicion of colorectal tumor. Gastroenterol Clin Biol. 2006 Feb;30(2):231-4. doi: 10.1016/s0399-8320(06)73158-x.

Reference Type RESULT
PMID: 16565655 (View on PubMed)

Miller J, Maeda Y, Au S, Gunn F, Porteous L, Pattenden R, MacLean P, Noble CL, Glancy S, Dunlop MG, Din FVN. Short-term outcomes of a COVID-adapted triage pathway for colorectal cancer detection. Colorectal Dis. 2021 Jul;23(7):1639-1648. doi: 10.1111/codi.15618. Epub 2021 Mar 29.

Reference Type RESULT
PMID: 33682302 (View on PubMed)

Other Identifiers

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HYH EC 093-66-01

Identifier Type: -

Identifier Source: org_study_id

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