Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Colorectal Neoplasms

Depression

Colonic Polyps

Polyps

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Pathological Conditions, Anatomical

Intestinal Polyps

Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Technically improved colonoscope with close focus high definition narrow band imaging.

Olympus Colonoscope CFHQ190AL

Tonya Kaltenbach, MD MS

We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.

Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.

Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study

Full Inspection With Narrow Band Imaging (NBI) for Detection of Flat Lesions And Tumors During Colonoscopy- The FIND FLAT Colonoscopy Study

Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.

Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.

Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.

Kansas City Veteran Affairs Medical Center

VA Palo Alto Health Care System

Co-Principal Investigator

Use of high definition narrow band imaging colonoscopy during examination for polyp detection.

Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.

High Definition NBI Colonoscopy

Use of high definition white light colonoscopy during examination for polyp detection.

Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.

High Definition White Light Colonoscopy

Total

Age, Continuous

Sex: Female, Male

Dr. Tonya Kaltenbach

Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm

Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.

Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging.

Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.

Percentage of Missed Lesions on Index Colonoscopy.

Percentage of Nonpolypoid (Flat) Missed Lesions

Overall Study

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Herbal and Botanical

All Drugs and Chemicals

Cola

The inclusion criteria are: (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.

The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn.

endocuff

MARIA FRAGAKI

Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal.

The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.

Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy

The primary outcome is the measurement of Endocuff-assisted colonoscopy adenoma and polyp miss rates, overall and in the proximal colon.

Venizelio General Hospital

MD, PhD

Tandem colonoscopy with BLI follow by WLI

Tandem colonoscopy with different image modalities

Tandem colonoscopy

Wai Keung Leung, MD

This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.

Study population:

Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is \<2.

Study design and randomization:

This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment.

BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

Blue Laser Imaging Versus Narrow Band Imaging Versus White Light Imaging for Detection of Adenoma in the Proximal Colon: A Prospective Randomized Study

proportion of patients with proximal adenoma detected on first examination

proportion of patients with proximal polyp detected on first examination

proportion of patients with proximal adenoma detected on second examination

proportion of patients with proximal polyp detected on second examination

Queen Mary Hospital, Hong Kong

The University of Hong Kong

Professor

Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal.

At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each.

A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal.

At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each.

A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.

Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment.

In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.

6-minute then 9-minute withdrawal

Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment.

In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.

9-minute then 6-minute withdrawal

Zhaoshen Li, M.D

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.

9 Minutes for Tandem Colonoscopy Withdrawal

Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy

Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.

AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.

ADR is the number of patients with at least one adenoma, divided by the total number of patients.

APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.

the number of participants with adenomas detected only during the second-pass colonoscopy divided by the total number of participants with adenomas detected during the tandem colonoscopy

No.85 Hospital, Changning, Shanghai, China

Yantaishan Hospital of Yantai City, Yantai, China

Seventh Medical Center of PLA Army General Hospital

The First Affiliated Hospital of Dalian Medical University

The First Affiliated Hospital of the Medical College, Shihezi University

Shanghai 8th People's Hospital

Shanxi Provincial People's Hospital

Qinghai People's Hospital

Leqing People's Hospital

Afﬁliated Hospital of North Sichuan Medical College

Zhejiang University

Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine

The General Hospital of Eastern Theater Command

Heilongjiang provincial hospital

The Second Hospital of Hebei Medical University

Changhai Hospital

Director of Gastroenterology Dept

Tandem colonoscopy with Linked Color Imaging system

Tandem colonoscopy with Narrow band imaging system

Different image enhanced endoscopy systems

Wai K Leung, MD

This is a prospective randomized trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance).

The primary outcome of this study is to compare the adenoma or polyp detection rates by LCI and NBI during the first examination. Secondary outcomes included adenoma/polyp miss rate by LCI or NBI. Other outcomes include sessile serrated adenomas or polyps (SSA/P) detection rates and advanced adenoma detection rates.

Study design and randomization:

This is a prospective randomized head-to-head trial comparing the adenoma detection rate of LCI with NBI. Eligible patients are randomly allocated in a 1:1 ratio to undergo tandem colonoscopy with LCI (LCI group) or NBI (NBI group). Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes and the LASEREO endoscopic system (Fujifilm Co, Tokyo, Japan) or the EVIS- EXERA 290 video system (Olympus Optical, Tokyo, Japan).

Colonoscopy:

Patients are instructed to take low-residue diet two days before colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation (routine bowel preparation). The assigned endoscopic system will be used and the colonoscope will advance to cecum under WL in all patients. Cecal intubation is confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. Once cecal intubation is performed, the colonoscope is withdrawn to the anus under LCI or NBI accordingly. All detected polyps will be removed during this examination. The withdrawal time of the first pass (minus the polypectomy site) will be measured by a stopwatch.

The size (measured with biopsy forceps), location, and morphology of polyps are recorded by an independent observer. The Boston Bowel Preparation Scale score is evaluated during examination.

Immediately after the first pass examination, a second examination will be performed by the same colonoscope and the same endoscopist. The colonoscope will be reintroduced to the cecum using WL and withdraw using the previously assigned method (ie LCI or NBI). Any polyp detected on second pass examination will be removed and the withdrawal time of the second pass will also be documented. All polyp specimens are clearly labelled for histological examination.

Histologic examination All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria.Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.

Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection

Tandem Colonoscopy Study of Linked Color Imaging Versus Narrow Band Imaging on Colorectal Adenoma Detection: A Prospective, Randomized Study

percentage of patients with advanced adenoma

percentage of patients with sessile serrated adenoma/polyp

Percentage of patients with adenoma/polyp detected

percentage of patients with adenoma/polyp missed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study	NCT01310699	Colorectal Neop... Colonic Polyps Colorectal Canc...	Olympus Colonos...	18 Years -	VA Palo Alto Health Care System
Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy	NCT04805567	Colon Polyp Endocuff	endocuff	50 Years -	Venizelio General Hospital
Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy	NCT04805567	Colon Polyp Endocuff	endocuff	50 Years -	Venizelio General Hospital
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma	NCT03696992	Colon Adenoma	Tandem colonosc...	40 Years -	The University of Hong Kong
9 Minutes for Tandem Colonoscopy Withdrawal	NCT04797065	Colon Polyp Colorectal Aden...	6-minute then 9... 9-minute then 6...	40 Years - 75 Years	Changhai Hospital
Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma Detection	NCT03336359	Colon Adenoma	Tandem colonosc...	40 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for tandem colonoscopy