Hiatal Hernia

Researchers are evaluating the combination of Anlotinib Hydrochloride Capsules and TQB2450 Injection as a postoperative adjuvant therapy for patients with esophageal squamous cell carcinoma (ESCC). This Phase II, open-label, single-arm study aims to assess the efficacy and safety of this combination treatment, focusing primarily on disease-free survival (DFS). The study also looks at one- and three-year DFS and overall survival rates, along with safety outcomes classified by adverse event severity. Participants will receive treatment in 21-day cycles, taking Anlotinib orally at 12 mg daily for the first 14 days, along with a single intravenous dose of 1200 mg TQB2450 on day one of each cycle. If participants experience side effects from Anlotinib, the dose may be reduced to 10 mg or 8 mg. The study treatment continues as determined by the researchers. During the study, participants will be closely monitored through laboratory tests and imaging to detect any cancer recurrence or progression. Researchers will track disease-free survival from the start of treatment up to 96 months, along with overall survival rates at one and three years. Safety will be evaluated by recording and categorizing adverse events. Participants are expected to follow up regularly and comply with study procedures throughout the treatment and observation period.

This research aims to evaluate the safety and performance of the ECLIPSIUM device in securing mesh during ventral hernia repair. It compares ECLIPSIUM, a bioresorbable polymer-based fixation device, to bioresorbable tacks to determine if it can reduce the risk of hernia recurrence. The study is a prospective, multi-center, randomized, single-blind trial designed to assess whether ECLIPSIUM offers clinical benefits in laparoscopic intraperitoneal onlay mesh ventral hernia repair procedures. Participants will receive one of two treatments: the ECLIPSIUM System, which applies a biodegradable polymer coating to the mesh and secures it with photoactivation using a special curing light, or resorbable tacks that fasten the mesh and are absorbed by the body over time. Each participant undergoes laparoscopic ventral hernia repair with mesh fixation using either method. The study will monitor outcomes over 12 months, including hernia recurrence and complications. During the study, participants will have assessments at 6 and 12 months to check for hernia recurrence and any complications. The trial includes follow-up visits and evaluations to monitor safety and effectiveness. Participants will be observed for the cumulative incidence of complications up to 12 months, and the primary outcome measurement is hernia recurrence at 6 months. The total duration of participation will vary depending on individual follow-up schedules.

Researchers are evaluating the combination of camrelizumab with chemoradiotherapy and chemotherapy in patients with advanced esophageal cancer who have not received any prior systemic antitumor treatment. This prospective single-arm exploratory clinical study aims to assess the safety and effectiveness of these treatments in patients with esophageal squamous cell carcinoma at advanced stages. The study is sponsored by Fujian Cancer Hospital and focuses on advanced first-line treatment for esophageal cancer. Participants will receive camrelizumab 200 mg through intravenous drip every three weeks, along with chemotherapy drugs including paclitaxel at 150 mg/m2 every three weeks and a platinum-based drug such as cisplatin, carboplatin, or nedaplatin. Radiotherapy will be administered at a dose of 5040 cGy over 28 fractions. After 2 to 3 cycles of chemotherapy, patients who show partial response or stable disease will receive local radiotherapy as part of the treatment plan. During the study, participants will be monitored with evaluations of tumor response and safety assessments. Researchers will measure the objective response rate over three years as the primary outcome, along with overall survival and progression-free survival during the same period. Patients will be followed regularly for treatment effects and side effects, and the total duration of participation may extend up to three years to capture long-term outcomes.

Researchers are exploring the use of blood-based biomarkers to improve the surgical treatment of patients with resectable adenocarcinomas of the esophagus and gastro-esophageal junction types I and II. This observational study aims to compare the frequency of circulating tumor cells (CTCs) in blood from peripheral veins versus tumor-draining veins, and to assess the prognostic value of additional biomarkers. The goal is to enhance preoperative staging and better identify patients at risk for metastasis, which could lead to more tailored treatment plans including neoadjuvant, peri-operative, or surgical approaches alone. The study involves collecting around 20 mL of blood from a peripheral vein and 40 mL from tumor-draining veins during surgery. Additionally, about 5 mL of lymphatic fluid will be collected from the thoracic duct if accessible. Blood samples will then be analyzed for CTCs, tumor-derived extracellular vesicles (tdEVs), and circulating tumor DNA (ctDNA) using specialized laboratory techniques. Resected tissue not needed for routine pathology will be stored in a biobank for future research. After surgery, annual blood samples will be taken during routine follow-up or at relapse. Participants will undergo blood and lymphatic fluid collection during surgery, with follow-up blood draws for up to five years. Researchers will measure the difference in CTC detection rates between blood sources over 24 months, assess other biomarkers, and correlate findings with clinical outcomes over seven years. Safety monitoring includes ensuring patients meet performance status and surgical fitness criteria. This long-term follow-up helps evaluate how the biomarkers relate to disease progression and treatment outcomes.

This research aims to gather and analyze data about two methods used to take small tissue samples from the esophagus: biopsies taken with forceps and brush biopsies. The study focuses on patients with heartburn or Barrett's esophagus, a condition that can lead to cancer. The goal is to understand how these biopsy methods may help doctors predict the development of precancerous changes or cancer over five years. Participants will undergo standard clinical care involving an upper endoscopy, during which both forceps and brush biopsies of the esophagus will be taken. These biopsy results will be collected and recorded in a research database for five years to observe their impact on medical decisions and patient outcomes. The study is observational and does not involve additional treatments beyond usual care. During the study, participants' biopsy results will be monitored and recorded over a five-year period. Researchers will assess how the biopsy findings influence care decisions and whether either biopsy method can predict disease progression. Participants will continue their routine medical visits and evaluations as part of this long-term observation, with all study-related data collected to support research goals.

Achalasia is a disorder affecting the movement of the esophagus and the relaxation of the lower esophageal sphincter, likely caused by nerve damage. This trial compares the features of reflux-related erosions after a treatment called per-oral endoscopic myotomy (POEM) with those in people who have reflux disease but no esophageal motility disorders. The study seeks to better understand the differences in esophagitis between these groups. Participants receiving POEM will be treated using a standardized method and given a single daily dose of an anti-secretory medication like esomeprazole for two months after the procedure. They will be followed for at least three months, during which proton pump inhibitors will be stopped for four weeks before assessment. Follow-up includes symptom questionnaires, endoscopy, and 24-hour pH monitoring to evaluate esophagitis and reflux characteristics. These findings will be compared with those from patients diagnosed with gastroesophageal reflux disease without motility disorders. During the study, participants will provide demographic and clinical data, and undergo pre- and post-treatment manometry. After three months, they will complete reflux symptom questionnaires and have an endoscopy and pH impedance test to measure esophageal acid exposure and observe esophagitis. Researchers will assess the size, type, and location of esophageal erosions to compare outcomes. The study spans from initial treatment through a six-month assessment period to monitor reflux and esophageal changes.

Researchers are studying the relationship between two non-invasive ways to observe the diaphragm muscle function in infants and young children who need breathing support in the Pediatric Intensive Care Unit (PICU). The study focuses on children from birth up to 12 months old who are on invasive respiratory support and are ready for extubation. It aims to understand how diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) measurements relate to each other in this patient group. The study involves monitoring the diaphragm muscle using two techniques at the same time while the patient breathes spontaneously during the extubation readiness test. dEMG is recorded with three skin electrodes placed around the chest and sternum for 15 to 30 minutes. Ultrasound is performed by trained operators using specific probes to measure diaphragm movement and thickness during three different breaths. These measurements help assess the diaphragm's role in breathing. Participants will undergo simultaneous dEMG and ultrasound assessments while stable and breathing on their own. The study collects data on diaphragm muscle activity and structure to analyze their association. Researchers will measure and compare diaphragm electrical activity and ultrasound parameters over about one year. The study includes consent, and patients participate only once. Safety and clinical stability are monitored throughout the process.

Researchers are investigating the development and recovery of ventilator induced diaphragm dysfunction (VIDD) in patients who require mechanical ventilation (MV) in the intensive care unit. This observational study aims to understand how diaphragm function, strength, and control decline over time during MV, including after removal of the breathing tube. The study also explores whether decreased diaphragm responsiveness from long-term MV affects the brain's motor control of the diaphragm. Participants undergo detailed respiratory muscle testing, including measurements of twitch transdiaphragmatic pressure triggered by magnetic stimulation of the phrenic nerves, and assessments of cortical control of diaphragm function. These tests are performed first within 48 hours of starting MV, then every three days, including two sessions after extubation. Additional evaluations include diaphragm ultrasound and monitoring of systemic inflammation. During the study, patients will have repeated assessments to track changes in diaphragm function and brain control over two years. Researchers will measure twitch pressures, diaphragm muscle activity, and inflammation markers. This helps clarify the rate of diaphragm decline and potential recovery after MV. The study is sponsored by RWTH Aachen University and involves close monitoring of patients in critical care settings.

Researchers are studying adult patients who are undergoing mechanical ventilation and preparing to be weaned off the ventilator. The study focuses on evaluating diaphragmatic effort and movement during a spontaneous breathing trial (SBT), which involves no assistance from the ventilator. The goal is to explore new ways to assess diaphragm function using diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) alongside existing measurements, to help detect diaphragmatic dysfunction earlier. Participants will be monitored during a spontaneous breathing trial lasting between 30 and 120 minutes, using continuous positive airway pressure (CPAP) with zero pressure support. Researchers will measure diaphragm function parameters, including diaphragmatic strain (LSdi, LSRdi), thickening fraction (TFdi), and airway occlusion pressures (94P0.1 and 94Pocc). These measurements will be taken at baseline before the trial, and then at 2 minutes (early), 15 minutes (intermediate), and 30 minutes (late) after the trial starts. During the study, patients will undergo regular assessments of diaphragm function using non-invasive imaging and pressure measurements. The research team aims to monitor changes in diaphragmatic longitudinal strain and strain rate throughout the SBT over a 7-day observation period. This detailed monitoring will help evaluate how the diaphragm performs during weaning from mechanical ventilation. Participants' safety and clinical condition will be observed throughout the study period.

Paraesophageal hernia can cause serious symptoms like reflux, chest pain, nausea, and life-threatening issues such as bowel obstruction and gastric volvulus. Repairing this hernia often has a high chance of coming back, with more than half of patients experiencing recurrence after primary repair. Recurrence and additional surgeries may lead to complications and lower quality of life. This observational study evaluates the effect of removing the hernia sac on crural tension during paraesophageal hernia repair. It includes patients aged 18 to 80 undergoing either planned or emergency surgery for symptomatic paraesophageal hernia. The study observes surgical details and outcomes immediately after the procedure and follows patients for 30 days to assess complications and other factors. Participants will have their surgery observed and data collected on hernia type, completeness of sac removal, and mesh usage right after surgery. Researchers will also monitor complications and compare patient demographics 30 days after surgery. This study aims to gather important information on surgical techniques and patient outcomes to improve care for paraesophageal hernia repair.