Clinical Research Directory

Assessment of the EndoR System in ESD for Colorectal Lesions

Gastrointestinal (GI) cancers are common and significant causes of cancer death worldwide. GI cancers grow from the mucosal layer. If pre-malignant and early cancers are removed en bloc at an early stage before they spread to lymph nodes, survival rates can be improved. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) were developed as minimally invasive, organ-sparing methods for removing pre-malignant and early GI cancers. While EMR is suitable for smaller lesions, ESD is typically required for larger lesions. ESD offers the advantage of a higher rate of complete, single-piece resection, which is associated with a lower risk of local recurrence compared to EMR. However, ESD is a technically complex procedure with a higher risk of complications, such as perforation and bleeding. Conventional ESD is performed using a flexible endoscope with a single instrument channel to access the GI tract. This setup presents several challenges, including difficulty in maintaining the endoscope in a stable position, limited ability to provide effective tissue traction, and frequent intraprocedural bleeding. As a result, ESD demands a high level of technical skills from surgeons. The EndoR Surgical System was developed to address these challenges, aiming to allow surgeons to operate two surgical instruments with enhanced dexterity and a broader range of motions. Both pre-clinical ex-vivo studies and in-vivo studies were conducted in the development of this surgical system. Six pre-clinical ex-vivo studies were conducted in porcine stomach between 2015 and 2023 and eleven pre-clinical in-vivo studies were conducted in live porcine models with the lesion sites at stomach, rectum and left colon between 2016 and 2024. These pre-clinical studies were conducted in LASEC-PWH, MISSC-PWH and Hybrid Operating Room of Multi-Scale Medical Robotics Center (MRC) accordingly. Based on data from the ex-vivo and in-vivo experiments, two key conclusions can be drawn: i) After several training sessions, the operator's performance became more consistent and efficient. ii) The dissection rate increased as the dissection area grew-a phenomenon not observed in conventional procedures using a single endoscope and dissection tool. From the results demonstrated from the pre-clinical studies, the EndoR Surgical System allows for greater dexterity and precision in manipulating instruments, which is particularly advantageous for larger lesions. This precision can lead to more effective dissection and reduced damage to surrounding tissues. This may also reduce the risk of complications associated with ESD. By minimizing trauma to adjacent structures, the likelihood of adverse events, such as bleeding or perforation, may be significantly lowered. Patients may experience faster recovery times, contributing to improved patients' satisfaction and outcomes. As the risk of complications decreases, endoscopic procedures like ESD could become accessible to a broader patient population. While performing ESD is generally considered safe, it still remains a technically demanding procedure with the assistance of the surgical robotic system. The use of surgical robots introduces the risk of equipment malfunctions, which can lead to complications during the procedure. Additionally, any technical issues may result in delays, potentially compromising patient safety. The attending physicians will monitor and examine the subjects as necessary and appropriate and work carefully to ensure their safety. In the event of an adverse reaction, countermeasures will be taken as appropriate, and focus will be placed on ensuring the safety of the subjects while the cause of the reaction is investigated. The objective of this study is to assess the safety and performance of the EndoR Surgical System for the treatment of patients with colorectal malignant lesions. Technical success, clinical success and any adverse events shall be recorded.

Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions

This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.

Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions

The study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.

Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient. The main questions it aims to answer are: * Does the cold forceps guarantee a complete endoscopic resection rate? * How many adverse events could the jumbo forceps reduce in comparison to CSP? * Does the lesion retrieval rate increase? * Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique. If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.

Diagnostic Performance of Endocytoscopy for Colorectal Lesions

Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. About 70% of colorectal cancers develop through the adenoma-cancer pathway. Early detection and resection of colorectal neoplastic lesions significantly reduce the morbidity and mortality of colorectal cancers. Colonoscopy is considered to be the preferred method for screening for colorectal lesions. However, as the number of endoscopic resection increases, the costs associated with pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, it will be very important and urgent to correctly judge the nature of colorectal lesions to avoid pathological diagnosis and then realize optical biopsy. Therefore, to clarify the endoscopic diagnosis of colorectal lesions, many endoscopic techniques have been applied clinically. Such as narrow-band imaging, magnifying narrow-band imaging endoscopy, magnifying chromoendoscopy and endocytoscopy. Endocytoscopy has two modes, EC-NBI mode and EC-staining mode. EC-NBI mode is to observe the microvessel on the mucosal surface of colorectal mucosa after switching the endoscopy to NBI mode. EC-V pattern is used to observe microvessels and then endoscopic diagnosis is performed. The EC-staining mode was that the cell nuclei and glandular duct morphology of colorectal lesions could be observed by endocytoscopy after chemical staining. Endocytoscopic diagnosis is performed clinically after observation of glandular ducts and nuclei. However, current studies on the diagnostic value of endoscopy in colorectal lesions are all retrospective studies with small samples, and there is a lack of clinical studies based on chinese population. Therefore, our center intends to conduct a study of a large sample to explore the diagnostic value of endoscopy in colorectal lesions.