Endoscopic Mucosal Resection

Researchers are evaluating the effectiveness of two substances used during the submucosal cushion formation stage of endoscopic submucosal resections for early esophageal malignant tumors. This randomized, single-center clinical trial compares a 0.4% hyaluronic acid solution called TS-905 Blue Eye against a hydroxyethylamide solution Voluven. The study aims to determine which solution better supports complete block resection with fewer additional injections during the procedure. Participants will be randomly assigned to one of two groups one group receiving submucosal endoscopic dissection with hydroxyethylamide injections, and the other with hyaluronic acid TS-905 Blue Eye injections. The resection procedure includes three stagesdelimitation, incision, and dissectionwhere the assigned solution is injected to help separate the lesion from underlying tissue. Patients are grouped based on lesion size for balanced comparison. During the study, researchers will measure the volume of solution used, the number of additional injections needed, and the duration of the procedure. These measurements will help assess the utility of each solution. The trial involves careful monitoring of the procedure and outcomes to evaluate effectiveness. Participants involvement includes undergoing the endoscopic procedure as assigned and consenting to study participation and follow-up assessments.

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 to restart eating after colorectal endoscopic submucosal dissection ESD, a procedure used to treat certain colorectal lesions. While previous studies on upper gastrointestinal ESD showed that early feeding within one day of the procedure did not increase complications and improved patient satisfaction, no studies have yet examined early feeding after colorectal ESD. This study aims to compare early feeding started within 24 hours after colorectal ESD to delayed feeding started after 24 hours, focusing on adverse events and patient satisfaction. Participants are randomly assigned to one of two groups. In the early feeding group, patients begin drinking water two hours after the procedure if no abnormalities are found during follow-up exams, then progress to a liquid diet and soft diet if no complications arise. In the delayed feeding group, patients fast on the day of the procedure and start a liquid diet 24 hours later, followed by a soft diet if tolerated. Both groups undergo standard colorectal ESD and monitoring such as physical exams, blood tests, and X-rays. Throughout the study, participants provide information on medical history, lesion details, procedure outcomes, and complications. Researchers assess early adverse events within 24 hours and delayed events beyond 24 hours, along with patient satisfaction using surveys. Follow-up visits after discharge help review outcomes and complications. The study collects detailed clinical and laboratory data and uses statistical methods to compare safety and satisfaction between the two dietary timing approaches.

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 patients 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, baselinesurgery 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 studys observational nature means no new treatments are given, and the total participation involves data analysis from past procedures.

This study evaluates the use of endoscopic submucosal dissection ESD as a treatment for early gastrointestinal neoplasia. It is a multicenter cohort study conducted in the United Kingdom to assess the effectiveness and safety of ESD for removing early dysplastic or neoplastic lesions in the gastrointestinal tract. The research aims to provide detailed information on patient demographics and lesion characteristics, such as size and location. Participants undergo the ESD procedure, which uses an endoscopic knife to remove lesions in one piece en bloc from the gastrointestinal tract. Data will be collected on key outcomes including en bloc resection rates, curative resection rates, R0 resection rates, and complications or adverse events. The study includes a follow-up period of two years during which these outcomes and any mortality are monitored. Throughout the study, patient information and clinical details are gathered to evaluate the procedures success and safety. Follow-up assessments occur over two years to capture outcomes such as curative resection rates and any complications within 28 days post-procedure. Researchers will also monitor mortality rates over the two-year period. The total participation duration is approximately two years, with data collected at specified timepoints to understand the procedures impact.

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.