Endoscopic Mucosal Resection

Researchers are evaluating the effectiveness of two different solutions used during the submucosal cushion formation stage of endoscopic submucosal resections for early esophageal malignant tumors. This randomized clinical trial is conducted at a single center and aims to compare 0.4% hyaluronic acid solution (TS-905 Blue Eye) and hydroxyethylamide solution in treating patients with early esophageal neoplasia. Patients are grouped based on the size of their lesions to ensure balanced comparison. Participants will undergo submucosal endoscopic dissection using either hydroxyethylamide or hyaluronic acid solution. Both procedures involve three stages: delimitation, incision, and dissection. The chosen solution is injected to create a cushion under the lesion, followed by careful cutting around the lesion with specialized equipment. There are two treatment groups, each including 15 patients receiving one of the solutions during their procedure. During the study, researchers will measure the volume of solution used, the duration of the procedure, and the number of additional injections needed. The main goal is to determine which solution better supports complete lesion removal with fewer injections. Participants will be monitored during the procedure, and the study is expected to continue until April 2026, ensuring careful assessment of treatment outcomes and safety throughout the process.

Researchers are evaluating the clinical and cost-effectiveness of endoscopic submucosal dissection (ESD) compared to surgery in patients with early gastric cancer (EGC) of the undifferentiated type that meets expanded indications. This multi-center, randomized controlled trial aims to provide high-level evidence due to limitations in previous retrospective studies. ESD is a less invasive treatment preserving the stomach, potentially improving quality of life and reducing medical costs compared to surgery, which remains the standard treatment. Participants are randomly assigned to one of two groups: the endoscopic submucosal dissection group, where an endoscopist performs the procedure using specialized devices, or the surgery group, where a surgeon performs gastrectomy with lymph node dissection. The study focuses on tumors confined to the mucosa without ulcers, 2 cm or smaller, with no lymph node or distant metastasis detected. This trial includes adults aged 19 to 75 and follows them over several years to assess outcomes. During the study, participants undergo evaluations including imaging and endoscopic assessments. Researchers monitor disease-free survival over three years as the primary outcome, along with secondary outcomes such as overall survival, curative resection rates, quality of life changes, treatment complications, and cost-effectiveness. Follow-up and assessments continue for up to five years after enrollment to gather comprehensive data on treatment impact and safety.

Intracerebral hemorrhage (ICH), a type of stroke causing significant death and disability, is being studied to see if early minimally invasive endoscopy-guided surgery improves patient outcomes compared to standard medical care. This trial focuses on adults with spontaneous supratentorial ICH, aiming to begin surgery within 8 hours of symptom onset. The study is a multicenter, randomized clinical trial led by Radboud University Medical Center, investigating both functional recovery and biological changes after treatment. Participants are randomly assigned to receive either minimally invasive endoscopy-guided surgery plus standard medical management or standard medical management alone. The surgical procedure uses neuronavigation-integrated devices approved for this purpose. Surgery must start within 8 hours of symptoms, and the trial includes detailed monitoring of brain imaging and immune profiles in a subgroup. The standard care group receives blood pressure management, stroke unit admission, and supportive care. Participants will be followed for up to one year with assessments at 6 days, 90 days, 180 days, and 365 days including functional scales like the modified Rankin Scale, stroke severity scores, quality of life questionnaires, and safety monitoring for complications or death. Imaging studies at baseline, 24 hours, and day 6 assess clot and edema changes. The trial also evaluates cost-effectiveness of the surgical approach. Overall participation spans up to one year with multiple clinical and imaging evaluations.

Researchers are investigating the best timing for restarting diet after colorectal endoscopic submucosal dissection (ESD), a procedure for certain colorectal lesions. While early feeding after upper gastrointestinal ESD has shown benefits like shorter hospital stays and better patient satisfaction without increased complications, no studies have yet explored this in colorectal ESD. This study aims to compare early feeding within 24 hours versus delayed feeding after 24 hours in patients undergoing colorectal ESD, focusing on early complications, length of stay, and patient satisfaction. Participants are randomly assigned to either the early feeding group where water intake starts two hours after the procedure if no issues are found, progressing to liquid and then soft diets, or the delayed feeding group which remains fasting on the procedure day and begins a liquid diet 24 hours later followed by a soft diet. Both groups undergo standard colorectal ESD and follow-up examinations two hours post-procedure to check for abnormalities. Patient satisfaction surveys and outpatient clinic visits occur after discharge to monitor delayed complications and overall outcomes. Throughout the study, participants undergo various assessments including blood tests, ECG, and imaging before and after the procedure. Researchers collect detailed data on patient characteristics, lesion features, procedural details, complications, hospital stay length, and pathology results. The main outcome measured is the rate of early complications within 24 hours. Secondary outcomes include hospital stay duration and patient satisfaction. Statistical analysis will compare the two groups to determine if early feeding is not inferior to delayed feeding. The study will continue monitoring participants for about one year post-procedure.

This research aims to evaluate the use of L-PRF (leukocyte and platelet rich fibrin) combined with the Entire Papilla Preservation (EPP) surgical technique for treating interproximal intraosseous periodontal defects. The study compares outcomes of the EPP technique with and without L-PRF in patients with periodontitis, focusing on clinical and radiographic periodontal parameters. It also assesses postoperative complications and sensitivity, addressing the need for minimally invasive and affordable treatments for severe periodontal disease. The trial involves 30 patients with periodontal defects treated using the EPP technique. Half of the patients will have their defects filled with L-PRF, an autologous blood-derived material that may aid healing and reduce inflammation, while the other half will receive the procedure without any filling material. Both groups will be evaluated at the start and 6 months after surgery. The L-PRF is prepared through centrifugation of the patient's own blood and applied as a filling to the defect site. Participants will undergo clinical evaluations including plaque index, bleeding on probing, probing depth, attachment levels, gingival margin position, and papilla measurements before surgery and 6 months later. Radiographic assessments using CBCT scans will measure defect size and healing. Patients will report pain levels 24 hours and 7 days post-surgery. Researchers will monitor healing progress, effectiveness of the procedure, and any complications over the 6-month follow-up period.

Researchers are evaluating the safety of the Su2ura4 GI system for endoscopic suturing and soft-tissue closure in patients undergoing endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric neoplastic lesions. This prospective, open-label study aims to measure rates of incomplete closure, bleeding, infection, leakage, and adverse device effects within specific timeframes after the procedure. Up to 25 patients will be recruited for this single-center study. Participants will undergo tissue resection by EMR or ESD, followed immediately by endoscopic suturing using the Su2ura4 GI system. The device is inserted through the gastroscope to grasp tissue and deploy full-thickness anchors in a controlled pattern, securing the suture with a knot device. The procedure is followed by a typical recovery with an expected one-night hospital stay and discharge the next day. The study includes six visits: screening, baseline/surgery day, discharge with 4-week, 3-month, and 6-month post-surgery follow-ups. During the study, patients will have physical exams, vital sign checks, blood tests, and quality of life questionnaires at regular intervals. A gastroscopy will be performed around 28 days post-procedure to check for local recurrence. Researchers will closely monitor safety outcomes including adverse device effects and serious events up to 6 months. Total participation time for each patient is up to about 6.5 months, with careful observation throughout the recovery and follow-up periods.

Researchers are investigating endoscopic removal procedures for cancerous and precancerous lesions in the upper and lower digestive tract. The study aims to evaluate the safety and effectiveness of different resection techniques, including mucosectomy, en bloc and piecemeal resection, endoscopic submucosal dissection (ESD) and its variants, and full-thickness resection. The anatomical areas studied include the esophagus, stomach, duodenum, colon, and rectum. The procedures studied involve various endoscopic resection methods used to remove lesions from the digestive tract. Techniques include endoscopic mucosal resection (EMR) for mucosal lesions, endoscopic submucosal dissection for larger or submucosal lesions, and full-thickness resection for infiltrating lesions involving the entire gastrointestinal wall. These methods are compared to assess their efficacy and safety. Participants who previously underwent endoscopic resection will have their medical records retrospectively reviewed. Researchers will analyze outcomes such as the rate of en bloc resection, complete removal of lesions, and recurrence within one year. They will also assess adverse events and costs within one month. The study's observational nature means no new treatments are given, and the total participation involves data analysis from past procedures.

Researchers are studying the use of endoscopic submucosal dissection as a treatment for early gastrointestinal neoplasia, which involves removing abnormal tissue from the digestive tract. This observational study collects data from multiple centers in the United Kingdom to assess the effectiveness and safety of this technique over time. The study aims to understand how well the procedure works in removing lesions completely and safely. Participants undergo endoscopic submucosal dissection, a procedure that uses a special endoscopic knife to remove lesions from the gastrointestinal tract in one piece. The study gathers detailed information about each patient's lesion size and location, as well as demographic details. Data on the success of complete lesion removal and any complications or adverse events are collected. During the study, researchers monitor outcomes such as curative resection rates over two years, en bloc resection rates at the time of the procedure, complication rates within 28 days after the procedure, and mortality rates over two years. Patient information and procedure details are recorded, with follow-up assessments extending up to two years to evaluate long-term results and safety.

This research aims to understand the best uses and methods of endoscopic vacuum therapy (EVT) for treating transmural defects in the upper gastrointestinal (GI) tract. These defects include anastomotic leakage after surgery, Boerhaave syndrome, iatrogenic perforations, and other injuries that affect the full thickness of the esophageal or gastric wall. Because these defects can cause serious complications like leakage of stomach contents and inflammation leading to sepsis, timely and effective treatment is critical. EVT has emerged as a promising endoscopic treatment, but questions remain about when and how to use it best. The study collects data retrospectively and prospectively on patients treated with EVT for these upper GI tract defects without administering any new treatments, as this is an observational study. It will assess different EVT techniques such as EsoSponge and VACStent, various vacuum pressures, and whether the therapy is applied inside the lumen or into cavities. The research focuses on patients who have already received EVT for anastomotic leakage after esophago-gastric surgery or esophageal perforations from different causes. Participants provide informed consent to allow collection of their medical data. Researchers will evaluate outcomes like the success rate of EVT over 1 to 3 years, mortality within 6 months, adverse events, number and duration of treatment cycles. The study helps identify which patients and defect types respond best to EVT and which techniques are most effective. The total study duration extends to October 2030, with no intervention changes required from participants during the observation period.

Researchers are evaluating a selective strategy using Endoscopic Submucosal Dissection (ESD) for treating large laterally spreading lesions (LSL) of the colorectum, which are at high risk of progressing to cancer. These lesions, especially those 20mm or larger, have a higher chance of malignancy and recurrence after removal. The study focuses on lesions with overt signs of submucosal invasive cancer (SMIC) or those at high risk for covert SMIC, aiming to improve histological staging and potentially reduce the need for surgery. The study compares two procedures: ESD, which allows for en-bloc resection and precise histopathological assessment, and Endoscopic Mucosal Resection (EMR), the current standard treatment that often requires piecemeal resection. Patients with lesions showing overt or high risk (≥10%) of covert SMIC are selected for ESD, while others with low-risk lesions may receive EMR. The research team will follow a prospective cohort design to assess this selective approach in the Western population. Participants will be monitored for outcomes including surgical referral rates at three months post-procedure, resection success rates, procedure duration, and adenoma recurrence rates over three years. The study involves detailed assessments of lesion removal quality and patient follow-up to evaluate the safety and effectiveness of the selective ESD strategy compared to EMR. Participation includes consenting adults referred for colorectal lesion resection and undergoing the assigned treatment with ongoing evaluations.