Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal

Intervention: Behavioral: No routine videorecording (on demand videorecording possible)

All screening centres (clusters) assigned to the routine video recording group will receive an appropriate number of video recorders and DVDs for each colonoscopy room. Screening centre coordinators will be responsible for the implementation of routine video recording of all screening colonoscopies (only withdrawal) in the centres. Every three months screening centre coordinators will be asked to send back all recorded DVDs. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team and then stored.

Implementation of routine videorecording

Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.

No routine videorecording

Michal F. Kaminski, MD, PhD

Jaroslaw Regula, MD, PhD

Maria Rupińska

Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy. The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy. The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP). Individuals aged 55-64 years are eligible to participate in the PCSP. In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database. Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group. Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal). Control group will be allowed to record colonoscopies on demand only. Then , the colonoscopy quality measures will again be monitored through a dedicated joint database. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team.

The Effect of Routine Video-recording on Colonoscopy Quality Indicators.

The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.

Proportion of patients with at least one adenoma identified (measured in screening program database).

Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)

Severe or moderate pain on a four point verbal rating scale (measured in screening program database)

Centre of Postgraduate Medical Education

Foundation for Polish Science

European Union

Maria Sklodowska-Curie National Research Institute of Oncology

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Diseases

Pancreatic Cancer

EUS with the navigation system first on, then off

EUS with the navigation system first off, then on

Incorporation of the EUS navigation system to the EUS scope

EUS navigation system

Armelle TAKEDA, PhD

Leonardo SOSA VALENCIA, MD

The implementation of Echo-endoscopy (or EUS for: Endoscopic UltraSound) is limited by the difficulty of obtaining quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Indeed, both cognitive and technical skills are required for endoscopic manipulation and image interpretation, as well as a thorough knowledge of intra-abdominal anatomy. The "EUS-GPS" system aims to assist the operator in understanding the orientation and location of the probe tip within the patient. For that, a Global Positioning System (GPS) for EUS procedures is intraoperatively provided, using a 3D-based model based on recorded preoperative data.

In this clinical investigation, the EUS GPS system is intended to help EUS operators to correctly navigate towards the pancreatic gland, perform a comprehensive assessment of the area of interest, and aid in the detection and identification of lesions.

Since its emergence in the 1980s, endoscopic ultrasound (EUS) is considered as one of the most accurate tools for the evaluation of the pancreatic gland and other gastrointestinal (GI) disorders. Despite its utility, the practice of EUS is still far from being part of every endoscopy suite due to its high set-up cost and the relative scarcity of credentialed experts. EUS implementation worldwide has been limited by the difficulty of achieving quality EUS procedures, since the accuracy of the method relies on the endoscopist's abilities. Both cognitive and technical competencies are required for endoscopic manipulation and image interpretation, as well as extensive knowledge of intraabdominal anatomy.

The aim of the APEUS (Augmented Pancreatic Endoscopic UltraSound) project is to overcome these two main difficulties by providing a Global Positioning System (GPS)-like intraoperative navigation for EUS procedures, using a 3D-based model on registered preoperative data. The hypothesis is that, thanks to this tool, the procedures time would be shortened, and the pancreas and its lesions would be completely imaged. This would reduce the demand for experts guiding trainees and shorten the EUS learning curve.

This first-in-human clinical study will enable the assessment of safety and qualitative performance of the EUS-GPS solution. The primary objective is to evaluate the EUS navigation system's procedure duration compared to standard procedure times (patient group with the EUS-GPS system vs control group without).

First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study

Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with (Groups EUS-NS) and without (Group EUS alone) use of the navigation system

Rate of intraoperative undesirable events and of any event related to the tested system (probe breaking, software crashing, etc.)

Collect of peroperative duration for registration, insertion, navigation to cardia, navigation from the cardia to the pancreas, pancreas examination, therapeutic step and overall duration of the procedure (quantitative). Results will be compared between cases with use of the navigation system first (Subgroup EUS-NS +) or in a second time (Subgroup EUS-NS -)

Questionnaire to assess the ease-of-use (integration in the standard-of-care workflow) of the EUS navigation system, filled by the EUS endoscopist (qualitative).

Questionnaire to assess the stressfulness of the EUS navigation system, filled by the EUS endoscopist (qualitative).

Collect adverse events, adverse device effects and device deficiencies during the procedure and up to 1 month after the EUS

A complete video recording of the procedure (endoscopic camera, ultrasound probe, pre-operative data real-time display and external camera) will be performed to assess the precision of the registration, using as anatomical points landmarks detectable in both CT and US images

Videos of the EUS procedure for further use in Artificial Intelligence-driven EUS research projects will be collected if the patient specifically consents to it. Recorded material will include the electromagnetic (EM) coordinates provided by the sensor. EUS video data associated with EM coordinates will be used to build databases for AI-driven EUS research projects

Questionnaire to evaluate the ergonomics and technological readiness, filled by the EUS endoscopist (qualitative).

IHU Strasbourg

Symptoms and General Pathology

Adenoma

Polyps

Adenomatous Polyps

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

A standard colonoscopy will be performed according to the standard of routine care. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. The AI system will capture video of the procedure in real time, and provide additional information on the detection of polyps, follow-up and prediction of pathology. The full-length colonoscopy videos will be annotated for the exact time of the identification of the anatomical landmarks, polyps, also for polyp- and procedural-related characteristics.

The AI system will capture the live video of the procedure and the AI feedback (polyp detection, tracking, and pathology prediction) will be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp or the information to predict pathology

Polyps detection by Artificial Intelligence

Daniel von Renteln

The investigators hypothesize that the clinical implementation of a deep learning AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps and other anatomical landmarks during colonoscopy. The objectives of this study are to generate preliminary data to evaluate the effectiveness of AI-assisted colonoscopy on: a) the rate of detection of adenomas; b) the automatic detection of the anatomical landmarks (i.e., ileocecal valve and appendiceal orifice).

In this trial, the investigators aim to evaluate the followings:

1. the accuracy of automatic detection of important anatomical landmarks (i.e., ileocecal valve, appendiceal orifice);
2. the accuracy of automatic detection of polyps/adenomas (PDR/ADR);

prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)

Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps

Efficacy of AI assisted colonoscopy to detect the proportion of patients with at least 1 polyp. Polyp detection rate with an AI.

Compare of the automatic detection of the ileocecal valve, appendiceal orifice, and the automatic calculation of the withdrawal time with manual detection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Routine Video-recording on Colonoscopy Quality Indicators.	NCT02054923	Colorectal Canc...	Implementation ... No routine vide...	-	Maria Sklodowska-Curie National Research Institute of Oncology
First-in-human Navigation Endoscopic Ultrasound (EUS) System Clinical Study	NCT05515705	Pancreatic Dise...	EUS navigation ...	18 Years -	IHU Strasbourg
Artificial Intelligence for Real-time Detection and Monitoring of Colorectal Polyps	NCT04586556	Adenomatous Pol...	Polyps detectio...	45 Years - 80 Years	Centre hospitalier de l'Université de Montréal (CHUM)

Spots Global Cancer Trial Database for quality indicators