Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Pathological Conditions, Anatomical

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Psychotropic Drugs

Fentanyl

Midazolam

Propofol

All participants will undergo to colonoscopy examination performed by competent/junior or expert/senior endoscopists (\>150-400 or \>400 previous colonoscopies, respectively). Bowel preparation was performed using different solutions, according to the clinical discretion of the attending, who indicated colonoscopy. After deep sedation by intravenous propofol with or without fentanyl or midazolam administration, a water-assisted colonoscopy was performed using a high-definition (HD) scope with white light (WL). Colonoscope trademark differs among participant centres.

Diagnostic high-definition white-light (HDWL) colonoscopy

Colonoscopy completion by caecal intubation seldom represents a significant effort for the endoscopist. In this situation, additional techniques are necessary to achieve this goal: patients' manual abdominal compression, postural changes, and endoscopist relay. To date, no tool allows colonoscopy technical difficulty grading.

This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

Colonoscopy is the most performed digestive endoscopy procedure worldwide. It is indicated for colorectal cancer screening, pre-existence surveillance, diagnostic approach in symptomatic patients, and therapeutic purposes. Bowel preparation is the most crucial quality criterion that guarantees appropriate colonic mucosa assessment. Other colonoscopy quality criteria included a colonoscope withdrawal time above 6 to 10 minutes and colonoscopy completion by caecal intubation.

Besides bowel preparation, some situations limit caecal intubation: stenosis, diverticulitis, or haemodynamic instability. In the absence of one of those situations or similar, caecal intubation must be the goal to be achieved by every endoscopist. However, it sometimes represents a significant effort for the endoscopist. It can require additional techniques such as manual abdominal compression, postural changes, colonoscopy restart, and another endoscopist's new attempt. Also, this increases caecal intubation time by over 10 minutes, more anaesthesia and post-colonoscopy abdominal pain, with a higher risk of unnoticed lesions.

To the best of our knowledge, there is no standard definition for colonoscopy technical difficulty in terms of caecal intubation or any tool that grades it based on previously mentioned additional techniques. For the moment, developed tools such as the Difficult Colonoscopy Score (DCS) to consider patients' pre-colonoscopy factors such as age, body mass index (BMI), sleep quality, and endoscopist experience. Other tools are based on a qualitative appreciation of the technical difficulty.

A tool that documents those endpoints constitutes an additional objective quality criterion for colonic mucosa assessment, with critical change management during intra-colonoscopy and post-colonoscopy. Noticed a technically difficult colonoscopy deserves a more prolonged withdrawal time, more photo documentation, a more cautious discharge, more detailed patient instructions, and a personalised follow-up directed to adverse events warnings. A patient with a previous technically difficult colonoscopy will be planned for an earlier next colonoscopy, with a risk assessment independently on the age, pre-colonoscopy consulting with detailing of more potential adverse events, planned in a particular time and with a different anaesthesia planning, and even performed by a more experienced endoscopist or in a referral centre.

This study pursues to describe the frequency of additional techniques for caecal intubation in a large sample of Argentinians in different centres who undergo colonoscopy for attending purposes, to develop a novel score for assessing colonoscopy technical difficulty.

The Argentina Brief Colonoscopy Difficulty Score (ABCD)

The Argentina Brief Colonoscopy Difficulty Score (ABCD): A Novel Tool to Estimate the Technical Difficulty of Colonoscopy With Caecal Intubation

Per each colonoscopy, there were documented:

1. The number of cases in which caecal intubation (CI) was or was not achieved.
2. Number of endoscopists who participated until caecal intubation, with the respective learning curve experience (expert/senior vs. non-expert/junior);
3. Requirement of restart colonoscopy (regardless of the responsible endoscopist);
4. Requirement of at least one postural change (from lateral to supine or vice versa);
5. Requirement of manual abdominal pressure.

ABCD score ranges from 0 to IV:

0: no difficulty. I: low difficulty. CI was issued after an effective abdominal compression. II: mild difficulty. CI was issued after a partial effective abdominal compression.

III: high difficulty. CI was issued after body rotation or change of endoscopist.

IV: very high difficulty. Declined cecal intubation after several attempts using additional techniques.

The caecal intubation time (CIT) is the time (mm:ss) from colonoscope insertion to the anal margin until caecal intubation (or its desertion after several attempts). Biopsy or therapeutic time will not be considered for this research.

The colonoscope withdrawal time (CWT) is the time (mm:ss) from caecal intubation (or its desertion after several attempts) until the returning to the anal margin after assessing the colonic mucosa thoroughly. Biopsy or therapeutic time will not be considered for this research.

Dose of propofol (mg) with or without fentanyl (mcg) or midazolam (mg) used during colonoscopy, following anaesthesia record.

Level of pain described by the patient one-hour post-colonoscopy. A general practitioner blind to the ABCD findings will ask the patient about pain from 1 (one) to 10 (ten), showing the Wong-Baker face pain rating scale, a type of visual analogue scale (VAS).

Austral University, Argentina

Hospital Nacional Profesor Alejandro Posadas

Institute of Gastroenterology and Advance Endoscopy

Principal investigator - Physician - GI Attending

Herbal and Botanical

Cola

Endoscopists perform colonoscopy with CADe system

Endoscopists perform colonoscopy without CADe system

Assist by artificial intelligence system for colon polyp detection

Jung Ho Bae, MD

Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate

Artificial intelligence technology based on deep learning is being applied in various medical fields, and research is being actively conducted to develop computer-aided detection (CADe) systems for colonoscopies to overcome the limitation of the variance of human skills. These well-trained CADe systems demonstrated high performance for neoplastic polyp detection and reported a 44% increase in adenoma detection rate (ADR) for endoscopists. However, the level of performance in the CADe system is not clear for expert endoscopists to be useful for ADR increase.

Furthermore, false positives(FPs) of the CADe system may negatively influence ADR during a screening colonoscopy. Accordingly, the investigators sought to identify the effect of the colonoscopy CADe system according to FP performance in endoscopists with various levels. The investigators hypothesized that the CADe system with low FPs would be useful to prevent the decrease in ADR in case of a high endoscopy workload according to the performance of CADe systems.

The primary outcome was the comparison of ADR between the control and AI groups according to the intervention system (SCAI vs ENAD system).

Effect of Two Colonoscopy AI Systems for Colon Polyp Detection

Effect of Two Colonoscopy AI Systems for Colon Polyp Detection According to the False Positive Rates of the Systems: A Single-center Prospective Study

proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician.

proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician.

proportion of colonoscopies with at least one polyp detected overall and as detected by the physician.

Seoul National University

Seoul National University Hospital

Digestive System Diseases

Colonic Diseases

Gastrointestinal Diseases

Intestinal Diseases

Anesthetics

Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.

Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.

Colonoscopy Force Monitor

Louis Y Korman, M.D.

The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Argentina Brief Colonoscopy Difficulty Score (ABCD)	NCT05422820	Colorectal Canc... Diagnoses Disea... Polyp of Colon Adenoma Colon	Diagnostic high...	18 Years - 79 Years	Institute of Gastroenterology and Advance Endoscopy
Effect of Two Colonoscopy AI Systems for Colon Polyp Detection	NCT05089071	Adenoma Colonoscopy Sessile Serrate...	Assist by artif...	45 Years - 100 Years	Seoul National University Hospital
Effect of Anesthesia on Force Application During Colonoscopy	NCT02101099	Outpatient Colo...	Colonoscopy For...	30 Years - 75 Years	Artann Laboratories
Effect of Anesthesia on Force Application During Colonoscopy	NCT02101099	Outpatient Colo...	Colonoscopy For...	30 Years - 75 Years	Artann Laboratories

Spots Global Cancer Trial Database for endoscopist

Every month we try and update this database with for endoscopist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endoscopist

Every month we try and update this database with for endoscopist cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endoscopist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.