Ignite Creation Date:
2024-07-17 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467929
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-14
Brief Title:
Prospective Collection of Endoscopic and Histopathologic Data from Endoscopic Procedures Performed in UZ Gent
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Prospective Collection of Endoscopic and Histopathologic Data from Endoscopic Procedures Performed in UZ Gent
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study in which images photos andor videos of lesions found during endoscopy will be collected and the associated data about these lesions size location in the body outcome of histology if resected and examined
The images will be taken while performing a diagnostic or therapeutic endoscopy This footage can be recorded in different light modalities and various lesions can be removed during one procedure It is of importance that the images are recorded in the best possible image quality
The images can be either endoscopic images or endoscopic images combined with room view this means that the endoscopic room can be filmed for example to visualize the endoscopist and thus show techniques of the procedure without the patient being identified The GDPR regulations will be respected at all times during the video recordings
The purpose of this registry is to create a database with images in the form of photos and video clips histopathological data demographic data of patients and data about the endoscopic procedure The recording of this data is standard with every endoscopic procedure that patients undergo at UZ Gent
The data will be used for the following purposes linking procedural outcomes with procedural data and patient data to improve endoscopic technique and to guarantee quality in our endoscopic unit In this way the investigators will also be able to identify trends and link adverse events back to the patient data with the aim of informing the patient In addition as a university center the investigators can train doctors in training with this educational material The footage can be shared via online andor live presentations that are only accessible toby healthcare workers and without the patient being identifiable Such material and its dissemination is essential to improve the safety of techniques such as those of today to share knowledge about techniques and in this way to train the next generation of doctors and nurses
The images will be taken while performing a diagnostic or therapeutic endoscopy This footage can be recorded in different light modalities and various lesions can be removed during one procedure It is of importance that the images are recorded in the best possible image quality
The images can be either endoscopic images or endoscopic images combined with room view this means that the endoscopic room can be filmed for example to visualize the endoscopist and thus show techniques of the procedure without the patient being identified The GDPR regulations will be respected at all times during the video recordings
The purpose of this registry is to create a database with images in the form of photos and video clips histopathological data demographic data of patients and data about the endoscopic procedure The recording of this data is standard with every endoscopic procedure that patients undergo at UZ Gent
The data will be used for the following purposes linking procedural outcomes with procedural data and patient data to improve endoscopic technique and to guarantee quality in our endoscopic unit In this way the investigators will also be able to identify trends and link adverse events back to the patient data with the aim of informing the patient In addition as a university center the investigators can train doctors in training with this educational material The footage can be shared via online andor live presentations that are only accessible toby healthcare workers and without the patient being identifiable Such material and its dissemination is essential to improve the safety of techniques such as those of today to share knowledge about techniques and in this way to train the next generation of doctors and nurses
Detailed Description:
Background Endoscopy and more specifically polypectomy during endoscopy is well established as an effective way of reducing cancer mortality The majority of lesions detected and removed at colonoscopy are adenomas 10mm in size without advanced histology These lesions have a low risk of progression to malignancy and are relatively easily removed by standard snare polypectomy with low complication rates Polyps that are sessile or flat and greater than 20mm in size are found in approximately 1 of all colonoscopies and are more difficult to manage These lesions known as large sessile lesions LSL have a high rate of advanced histology Traditionally they have been managed by referral for open or laparoscopic surgery which is definitive but invasive costly and associated with a significant mortality risk in patients with advanced age or comorbidities Endoscopic Mucosal Resection EMR has emerged in recent years as an alternative to surgery that is now becoming the standard of care It is an outpatient procedure which is effective safe and less costly than surgery when delivered at a tertiary referral centre
Prospective studies have been successful in addressing several aspects of the resection of LSL producing robust information on the efficacy of the procedure recurrence rates bleeding complications and mortality and costs when compared to surgery Assessment and management strategies for bleeding and deep mural injury or perforation have been derived from analysis of the data Snare tip soft coagulation of the resection margin post-EMR has been shown to reduce recurrence in a randomised controlled trial
There remain a number of unanswered questions regarding the endoscopic resection of large lesions and a new study incorporating a greater number of endoscopy units around the world will allow these to be addressed as well as answer questions on the clinical effectiveness of the technique Enhancing the prediction of submucosal invasive cancer advanced lesion classification validation of the assessment of deep injury treatment of lesion margins post resection to reduce recurrence prevention and prophylaxis of bleeding and subtype analyses of the different histological groups of colonic lesions will be examined
In addition other techniques such as endoscopic submucosal dissection ESD and full thickness resection FTR have emerged in recent years and require assessment of their performance versus endoscopic mucosal resection in prospective observational studies
The same techniques EMR and ESD are used to resect lesions in the upper gastrointestinal tract oesophagus stomach and small intestine and the same prospective observations are necessary to assess effectiveness of these techniques and outcomes to improve future upper gastrointestinal endoscopy
Trial objectives This monocenter trial aims to prospectively collect video material images and data of diagnostic and therapeutic endoscopic procedures and the data of the follow up The imaging during the endoscopy can be done in white light narrow-band imaging NBI blue-light imaging BLI I-scan linked-color imaging or any other available image enhancement technique including dye-enhancement with indigo carmine or methylene blue
The aim of this study is to collect these data prospectively in het UZ Gent The collected videos images and data will be used for educational education andor training of fellows publications and postgraduate education or scientific discussion amongst peers scientific meetings and presentations and medical research purposes by all participating sites
Endpoint Creation of a large digital database of prospectively collected images videos and data of endoscopic procedures using any type of imaging technique eg white light endoscopy video chromoendoscopy and with consecutive resection of lesions providing a corresponding histology report
Prospective studies have been successful in addressing several aspects of the resection of LSL producing robust information on the efficacy of the procedure recurrence rates bleeding complications and mortality and costs when compared to surgery Assessment and management strategies for bleeding and deep mural injury or perforation have been derived from analysis of the data Snare tip soft coagulation of the resection margin post-EMR has been shown to reduce recurrence in a randomised controlled trial
There remain a number of unanswered questions regarding the endoscopic resection of large lesions and a new study incorporating a greater number of endoscopy units around the world will allow these to be addressed as well as answer questions on the clinical effectiveness of the technique Enhancing the prediction of submucosal invasive cancer advanced lesion classification validation of the assessment of deep injury treatment of lesion margins post resection to reduce recurrence prevention and prophylaxis of bleeding and subtype analyses of the different histological groups of colonic lesions will be examined
In addition other techniques such as endoscopic submucosal dissection ESD and full thickness resection FTR have emerged in recent years and require assessment of their performance versus endoscopic mucosal resection in prospective observational studies
The same techniques EMR and ESD are used to resect lesions in the upper gastrointestinal tract oesophagus stomach and small intestine and the same prospective observations are necessary to assess effectiveness of these techniques and outcomes to improve future upper gastrointestinal endoscopy
Trial objectives This monocenter trial aims to prospectively collect video material images and data of diagnostic and therapeutic endoscopic procedures and the data of the follow up The imaging during the endoscopy can be done in white light narrow-band imaging NBI blue-light imaging BLI I-scan linked-color imaging or any other available image enhancement technique including dye-enhancement with indigo carmine or methylene blue
The aim of this study is to collect these data prospectively in het UZ Gent The collected videos images and data will be used for educational education andor training of fellows publications and postgraduate education or scientific discussion amongst peers scientific meetings and presentations and medical research purposes by all participating sites
Endpoint Creation of a large digital database of prospectively collected images videos and data of endoscopic procedures using any type of imaging technique eg white light endoscopy video chromoendoscopy and with consecutive resection of lesions providing a corresponding histology report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None