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

NCT06165328 | Recruiting DMC

• 1 other identifier: HYH EC 093-66-01
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patients at Risk of Colorectal Cancer

Keywords

colorectal tumor; colorectal cancer; CT scan; colonoscopy

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield in diagnosis colorectal tumor

  Sensitivity, specitivity, accuracy

  2 weeks

Secondary Outcomes (1)

• Procedure-related adverse events

  2 weeks

Study Arms (1)

Cohort1

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

Diagnostic Test: CT and colonoscopy

Interventions

CT and colonoscopy 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.

Cohort1

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients aged 50-70 years old who underwent FIT test for an indication of colorectal cancer screening as National program of Thailand.

You may qualify if:

• Fit test +
• Normal platelet count and normal result of PT, PTT

You may not qualify if:

• pregnancy or lactation
• uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
• recent coronary artery disease within 3 months
• eGFR lesser than 30 mL/min/1.73m2
• hemophilia or uncontrolled or uncorrected coagulopathy

Sponsors & Collaborators

• Hat Yai Medical Education Center: lead
• HatYai Hospital: collaborator

Study Sites (1)

Hatyai Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Related Publications (6)

• 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.

  PMID: 35505243 RESULT

• 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.

  PMID: 30665995 RESULT

• 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.

  PMID: 37497916 RESULT

• 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.

  PMID: 17114203 RESULT

• 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.

  PMID: 16565655 RESULT

• 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.

  PMID: 33682302 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for CBC, Coagulogram, BUN, Creatinine, Electrolyte, Iron study, CEA Stool for FIT test pathologic obtained (in case with polyp or malignancy)

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Arunchai Chang, MD

  Division of Gastroenetrology, Department of Internal Medicine, Hatyai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arunchai Chang, MD

CONTACT

+66650979414; busmdcu58@gmail.com

Araya Kaimook, MD

CONTACT

+66815424454; araya@cpird.in.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division of Gastroenterology, Department of Internal Medicine, Hatyai Hospital

Study Record Dates

• First Submitted: December 2, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)