Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
| The Second Affiliated Hospital of Guangzhou University of Chinese Medicine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Texture and Color Enhancement Imaging (TXI) is a newly developed image-enhancing endoscopy technology that has show potential in improving detection of colorectal lesions. This multicenter, randomized, tandem trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of diagnosis of premalignant lesions.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXI (Group A) | Experimental | Arm undergoing colonoscopy with TXI |
|
| TXI followed by WLI (Group B) | Experimental | Arm undergoing initial inspection under TXI first, followed by second inspection with WLI |
|
| WLI (Group C) | Active Comparator | Arm undergoing normal colonoscopy with WLI |
|
| WLI followed by TXI (Group D) | Active Comparator | Arm undergoing initial inspection under WLI first, followed by second inspection with TXI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TXI (Group A) | Procedure | Patients in Group A will undergo colonoscopy with TXI. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma detection rate | the number of patients with one or more adenomas detected and removed divided by the total number of patient | 1 years |
| sessile serrated lesion detection rate | the number of patients with one or more sessile serrated lesions detected and removed divided by the total number of patients | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| adenoma miss rate | the number of adenomas detected during the second examination divided by the total number of adenomas detected during the first and second colonoscopy | 1 years |
| sessile serrated lesion miss rate |
Not provided
Inclusion Criteria:
patients aged 45-85 years and scheduled for screening colonoscopy who provided written informed consent
Exclusion Criteria:
Surveillance, diagnostic or therapeutic colonoscopy
Patients with an already known or suspected colorectal tumour
Patients with alarming symptoms and signs, including haematochezia, melena, weight loss or anaemia without specific causes, an abdominal mass and positive digital rectal examination
Pregnant or lactating women
Patients with gastrointestinal tract obstruction
Patients with inflammatory bowel diseases, hereditary CRC syndromes or serrated polyposis syndrome
Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
Patients with failed cecal intubation
Patients with poor bowel preparation quality that necessitated a second bowel preparation
Patients with a history of colonic resection
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoshen Li, MD | Contact | 86-021-31161365 | li.zhaoshen@hotmail.com | |
| Yu Bai, MD | Contact | 86-021-31161335 | baiyu1998@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoshen Li, MD | Changhai Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38224857 | Background | Wei J, Zhao S, Bai Y. Impact of Texture and Color Enhancement Imaging on Adenoma and Sessile Serrated Lesion Detection: Much More to Explore. Gastroenterology. 2024 Jul;167(2):413-414. doi: 10.1053/j.gastro.2024.01.014. Epub 2024 Jan 13. No abstract available. | |
| 37451283 | Background | Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| Huadong Hospital | OTHER |
| Shanghai 6th People's Hospital | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| The General Hospital of Eastern Theater Command | OTHER |
| Jiangsu Provincial People's Hospital | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| Wenzhou Central Hospital | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| Shanxi Coal Center Hospital | UNKNOWN |
| Dalian Municipal Central Hospital | OTHER |
| Seventh Medical Center of PLA Army General Hospital | OTHER |
| Henan Provincial People's Hospital | OTHER |
| Zunyi Medical College | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| The Third People's Hospital of Chengdu | OTHER |
| Lanzhou University Second Hospital | OTHER |
| The Third People's Hospital of Jingdezhen | UNKNOWN |
| Fudan University Attached Tumor Hospital | UNKNOWN |
| Qingyuan People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
| TXI followed by WLI (Group B) |
| Procedure |
Patients in group B will first undergo colonoscopy with TXI and every polyp found should be removed. Then switch to WLI for a second withdrawal to detect lesions that were not observed the first time. |
|
| WLI (Group C) | Procedure | Patients in Group C will undergo colonoscopy with WLI. |
|
| WLI followed by TXI (Group D) | Procedure | Patients in group D will first undergo colonoscopy with WLI and every polyp found should be removed. Then switch to TXI for a second withdrawal to detect lesions that were not observed the first time. |
|
the number of sessile serrated lesions detected during the second examination divided by the total number of sessile serrated lesions detected during the first and second colonoscopy
| 1 years |
| 37839498 | Background | Young E, Rajagopalan A, Tee D, Sathananthan D, Hoile S, Singh R. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. |