Clinical Research Directory

Multi-center Evaluation of the Clinical Utility of ESD in the Western Population

The aim of this multi-center study is to prospectively document the clinical utility of ESD.

The Improvement Effect of Real-time Artificial Intelligence Assisted Identification of Bleeding Points on Hemostasis Efficiency in Endoscopic Submucosal Dissection

The goal of this clinical trial is to learn if an artificial intelligence (AI) system that identifies bleeding points in real time can help stop bleeding faster during endoscopic submucosal dissection (ESD) - a minimally invasive surgery for early digestive tract cancer or precancerous lesions. It will also learn about the AI system's effect on surgery-related problems (like perforation or delayed bleeding) and total surgery time. The main questions it aims to answer are: 1. Does the AI system shorten the time it takes to stop each bleed during ESD? 2. How does the AI system affect the rate of surgery-related problems and total surgery time? Researchers will compare two groups to see if the AI system improves hemostasis efficiency: 1. AI group: During ESD, the AI system will real-time spot and mark bleeding points. Doctors will use these marks to stop bleeding. 2. Control group: Doctors will use the same equipment but without the AI system - they will find and stop bleeding using their own experience. Participants will: 1. Have ESD surgery for esophageal, stomach, or colorectal lesions that need this treatment; 2. Be randomly assigned to either the AI group or the control group; 3. Attend follow-up checks in 14 days after surgery to check for complications; 4. Have their surgery videos reviewed by experts to record hemostasis time and total surgery time.

Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions

Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.

Evaluation of Biomechanical Forced During the Practice of Endoscopic Submucosal Dissection

The prevalence of musculoskeletal disorders (MSDs) among endoscopists is estimated between 29 and 89%. The most common disorders are carpal tunnel syndrome, De Quervain tenosynovitis, lateral epicondylitis and neck pain. Factors associated with MSD among gastroenterologists practicing endoscopy are: the high number of procedures (more than 20/week), the procedure time (more than 16 hours/week) and the number of years of practice.With the evolution of digestive endoscopy superficial cancer can endoscopically be removed by endoscopic submucosal dissection (ESD) avoiding surgical resections. The number of procedures is increasing, with longer examination times in case of ESD (about 2 hours). This volume of hours and procedures may in the near future further increase the risk of MSDs in the population of gastroenterologists. Some good practice recommendations have been proposed to improve practitioner comfort, similar to what is recommended for digestive surgeons. It is recommended to use a height-adjustable examination table, position the screen at eye level, and use a seat during the procedure. There is little data on the biomechanical forced experienced by an endoscopist when performing endoscopy and colonoscopy, and none when performing ESD. The aim of this study is to evaluate the biomechanical forced experienced by the gastroenterologist during an ESD the practice of submucosal dissection.

Comparison of the Effects of Target-Controlled Infusion Method and Manual Propofol Administration on Respiratory Function, Recovery, and Electroencephalogram in Endoscopic Submucosal Dissection Cases

Endoscopic submucosal dissection (ESD) has become widely used as a minimally invasive alternative for the resection of early-stage gastrointestinal neoplasms. Due to the lengthy procedure time and intense pain caused by stretching, cutting, and dissecting the gastric wall during ESD, a deeper level of sedation is recommended compared to traditional endoscopic procedures (1). While ensuring adequate patient immobilisation during ESD, preserving respiratory function and rapid recovery are important clinical goals. Total intravenous anaesthesia (TIVA) is an alternative method to inhalation anaesthesia, achieved through the combination of agents such as propofol and remifentanil. TIVA applications can be performed using manual or target-controlled infusion (TCI) systems. TCI systems aim to achieve and maintain the targeted plasma or effect site concentration based on pharmacokinetic models. These systems have been shown to provide advantages such as more stable depth of sedation during endoscopy, less haemodynamic fluctuation, and faster recovery (2-4). Preserving spontaneous breathing is preferred during ESD procedures, which requires careful monitoring of respiration. The Capnostream® device records four variables (SpO₂, RR, non-invasive EtCO₂, heart rate) every 30 seconds via a nasal cannula and integrates them into a single, dimensionless value called the integrated pulmonary index (IPI). The IPI can range from 1 to 10, with 4 and below requiring intervention and 8 to 10 representing the normal range. Furthermore, the use of the bispectral index (BIS) enables objective monitoring of anaesthesia depth by analysing EEG waves and can increase the safety of the recovery process (5). This study aims to compare the effects of manual TIVA and TCI applications on recovery time, BIS, and respiratory parameters during ESD procedures in the stomach or colon region performed under sedation in the endoscopy unit. The findings will contribute to the safer and more effective planning of sedation applications. References; 1. Sasaki T, Tanabe S, Azuma M, Sato A, Naruke A, Ishido K, et al. Propofol sedation with bispectral index monitoring is useful for endoscopic submucosal dissection: a randomised prospective phase II clinical trial. Endoscopy. 2012 Jun;44(6):584-9. 2. Chang YT, Tsai TC, Hsu H, Chen YM, Chi KP, Peng SY. Sedation for gastrointestinal endoscopy with the application of target-controlled infusion. Turk J Gastroenterol Off J Turk Soc Gastroenterol. 2015 Sep;26(5):417-22. 3. Sarraj R, Theiler L, Vakilzadeh N, Krupka N, Wiest R. Propofol sedation in routine endoscopy: A case series comparing target controlled infusion vs manually controlled bolus concept. World J Gastrointest Endosc. 2024 Jan 16;16(1):11-7. 4. García Guzzo ME, Fernandez MS, Sanchez Novas D, Salgado SS, Terrasa SA, Domenech G, et al. Deep sedation using propofol target-controlled infusion for gastrointestinal endoscopic procedures: a retrospective cohort study. BMC Anaesthesiol. 10 August 2020;20(1):195. 5. Sandler NA, Hodges J, Sabino M. Assessment of recovery in patients undergoing intravenous conscious sedation using bispectral analysis. J Oral Maxillofac Surg Off J Am Assoc Oral Maxillofac Surg. 2001 Jun;59(6):603-11; discussion 611-612. 6. Ding Y, White PF. Simplified quality of anaesthesia scoring system. Anaesthesia. 1992 Oct;47(10):906-7.

Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection

Currently, there are no clear guidelines regarding the optimal timing for dietary restart after gastrointestinal endoscopic submucosal dissection (ESD). While several studies have addressed upper gastrointestinal ESD, a meta-analysis reported that early feeding, initiated within one day after the procedure, showed no statistically significant difference in complication rates compared to delayed feeding initiated after two or more days. Moreover, early feeding was associated with shorter hospital stays and higher patient satisfaction. However, to the best of our knowledge, no studies have investigated early feeding in colorectal ESD. On the other hand, in the context of surgical procedures involving the gastrointestinal tract, several studies suggest that early feeding may offer clinical advantages over delayed feeding. The aim of this study is to explore the optimal timing for dietary restart following colorectal ESD. In the early feeding group (\<24 hours), patients begin water intake if no abnormalities are observed during a follow-up examination conducted two hours post-procedure. If no further issues arise after an additional two hours, a liquid diet is initiated. In contrast, the delayed feeding group (\>24 hours) maintains fasting on the day of the procedure and begins a liquid diet the following day. The study will compare the early and delayed feeding groups in terms of post-ESD early complications (e.g., bleeding, perforation, post-coagulation syndrome), length of hospital stay, patient satisfaction, and delayed complications.

Endoscopic Resection of Gastrointestinal Neoplasms

The study aims to retrospectively investigate the endoscopic resection procedures of cancerous and precancerous lesions of the upper and lower digestive tract in order to evaluate the efficacy and safety outcomes and to compare different resection techniques. In particular, the resection techniques investigated will be mucosectomy, en bloc and piecemeal, endoscopic submucosal dissection (ESD) and its variants, full-thickness resection. The anatomical districts involved will be the esophagus, stomach, duodenum, colon and rectum.

Endoscopic Submucosal Dissection for Early GI Neoplasia in the United Kingdom

Multicentre cohort study on the use of endoscopic submucosal dissection for the treatment of early gastrointestinal neoplasia.

Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are: Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system. Participants will: Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system. Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

Endoscopy-Assisted Tracheal Intubation Versus Conventional Tracheal Intubation for Endoscopic Submucosal Dissection (ESD): a Prospective Randomized Controlled Study

This study plans to enroll 148 patients undergoing upper gastrointestinal endoscopic submucosal dissection (ESD). Patients will be randomly divided into a control group (conventional tracheal intubation) and an experimental group (endoscopy-assisted tracheal intubation). Patients meeting the inclusion criteria and not falling under the exclusion criteria will be invited to participate in the study. Upon providing voluntary consent, the research physician will arrange for the patient's inclusion in the study. After signing the informed consent form, the research physician will collect the patient's basic information, medical history, and other details, followed by timing the preoperative preparation period and evaluating postoperative discomfort

Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions

Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.

The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.