Clinical Research Directory

Feasibility and Ergonomic Impact of A Virtual Reality Headset in Endoscopic Procedures

The purpose of this study is to assess the feasibility of using a virtual reality headset (VRH) during endoscopy and its impact on the endoscopist ergonomics. We will use the Apple Vision Pro during approximately 140 endoscopic procedures during which ergonomics will be assessed.

Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration

This study is a pragmatic, randomized controlled pilot trial comparing remimazolam with propofol for endoscopic procedures, designed to assess the feasibility and clinical outcomes associated with implementing a pragmatic randomized trial of sedation practices in the endoscopy setting.

"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?"

Study Objective: This observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications. Study Population: The study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden. Research Questions: 1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy? 2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications? Methods: Children scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication. After the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol. The airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.

Endoscopy Immersion Study.

Endoscopy services are under significant pressure and endoscopy training academies and immersion training are under review at a national level. To date, there has been no comprehensive evaluation of the different approaches to immersion training or a large-scale study looking at its impact on trainees and/or endoscopy services. The purpose of this study is to perform a process, impact and economic evaluation of current immersion training practices to determine if they are impactful and value for money.

Is Cap Assisted Endoscopy Useful in Acute Upper Gastrointestinal Bleeding ?

High digestive bleeding (HDH) is a medical emergency associated with high morbidity and mortality rates and significant healthcare costs. Upper endoscopy can locate the bleeding and treat it. However, the source of bleeding can be difficult to identify, even for the most experienced endoscopists, due to the location of the bleeding (posterior wall of the bulb, gastric or duodenal folds, papillary region, esophagogastric junction), instability of the tube due to gastric and pyloric contractions and respiratory movements, leading to longer procedure times, hemostasis failure, or even the absence of bleeding visualization. The use of a cap attached to the endoscope facilitates exploration of blind areas of the colonic mucosa located behind folds, thus reducing the rate of missed polyps and cecal intubation time. To date, there is no study evaluating the systematic use of a cap in patients with suspected high digestive bleeding. A series of four cases demonstrated its benefit, allowing for better exposure of the bleeding lesion, better unfolding of intestinal folds, and thus a more effective and quicker hemostatic treatment.

Effect of Visualized Meditation on Anxiety, Pain, and Comfort in Patients Undergoing Endoscopy

Endoscopy is one of the most frequently performed procedures for the early diagnosis and treatment of many diseases and plays a crucial role in the diagnosis and treatment of upper gastrointestinal disorders. Sometimes, endoscopy may be the only option for detecting certain diseases of the stomach and larynx. However, for many patients, endoscopy is considered an invasive, highly painful, and extremely uncomfortable procedure. Furthermore, anxiety and fear felt before the procedure can cause physical and emotional discomfort, disrupt patient comfort, and cause pain.

Artificial Intelligence in Assessing Gastric Intestinal Metaplasia Via the EGGIM Score

The endoscopic grading system (EGGIM) has been widely used to assess the extent of gastric intestinal metaplasia during endoscopy. Investigators developed an artificial intelligence (AI) system to automatically evaluate the extent of gastric intestinal metaplasia (GIM) and calculate the EGGIM scores in endoscopy examination. This study is a prospective, multi-center study aimed at exploring the performance and reliability of AI-EGGIM scoring. This is a prospective study designed to validate the AI-EGGIM system in a larger cohort. The study protocol was developed based on preliminary experience from a prior investigation (NCT05464108).

Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer

This study aims to test the hypothesis that the diagnosis for histological type, histological grade, LAUREN type, HER-2 expression, MSI/dMMR status, and EBV status in gastric cancer is at least as reliable when performed on endoscopic biopsy specimens as on surgical resection specimens.

Raman Spectroscopy in the Diagnosis of Extrahepatic Cholangiocarcinoma - a Pilot Study

Diagnosis of extrahepatic cholangiocarcinoma is challenging because the yield of imaging and tissue sampling is limited. Raman spectroscopy is an optical method based on the analysis of scattered monochromatic light. Raman spectroscopy is able to provide a molecular 'fingerprint' of the tissue to determine its type. The aim of this pilot study was to develop a methodology for in vivo Raman spectroscopy in bile ducts to improve the current diagnostic capabilities of extrahepatic cholangiocarcinoma.

Use of Virtual Reality Technologies in Management of Anxiety and Discomfort During Endoscopy Procedure

Digestive endoscopies are performed either for diagnostic purposes (e.g. suspicion of cancer or monitoring of chronic diseases) or for therapeutic purposes (treatment of digestive haemorrhage, removal of polyps, etc.). Some endoscopies are performed under local anaesthetic, which can cause considerable anxiety in anticipation of the procedure and considerable discomfort during the procedure. Other endoscopies are performed under general anaesthetic for more extensive procedures on outpatients or inpatients. Anxiety prior to anaesthesia is likely to increase the perception of pain, increase the need for anaesthetic products and thus increase the time to complete awakening. Complementary techniques such as hypnotherapy can be used before the operation, with proven effectiveness. But these techniques require dedicated and specifically trained staff, as well as additional time. Virtual reality technologies, and in particular virtual reality headsets, allow instant immersion in a relaxing world. Therapeutic virtual reality headsets (TRVH) have been shown to be effective in reducing pre-operative anxiety and pain perception. Our hypothesis is that the use of a CRVT could reduce the consumption of anaesthetic products, reduce anxiety, improve overall satisfaction and reduce the length of outpatient hospitalisation during digestive endoscopy procedures.

Prospective Collection of Endoscopic and Histopathologic Data from Endoscopic Procedures Performed in UZ Gent

This is an observational study in which images (photos and/or 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 and/or live presentations that are only accessible to/by 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.

French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.

AI-assisted White Light Endoscopy to Identify the Kimura-Takemoto Classification of Atrophic Gastritis

Grading endoscopic atrophy according to the Kimura-Takemoto classification can assess the risk of gastric neoplasia development. However, the false negative rate of chronic atrophic gastritis is high due to the varying diagnostic standardization and diagnostic experience and levels of endoscopists. Therefore, this study aims to develop an AI model to identify the Kimura-Takemoto classification.

Minimally Invasive Endoscopic Treatment of Zenker's Diverticulum Comparing LigaSureTM vs SB-Knife.

The main purpose of this trial is to evaluate two devices used in the treatment of Zenker Diverticulum using flexible endoscopy (LigaSure and SB-knife). Analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.