Clinical Research Directory

VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery

Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL. Methods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.

Outcome of Patients With Malignant Gastric Outlet Obstruction Undergoing Endoscopic Ultrasound-guided Gastroenterostomy or Enteral Metal Stenting

Gastric outlet obstruction (GOO) refers to a mechanical blockage of the distal stomach or duodenum that prevents normal passage of food and liquids. According to literature, 50-80% of GOO cases are caused by malignant tumors compressing or directly invading the gastrointestinal tract. Among patients with pancreatic cancer, 15-20% develop GOO \[1,2\]. GOO is also considered a poor prognostic factor in malignancy, with a median survival time of only 3-6 months \[3\]. Traditionally, management options for GOO include surgical gastrojejunostomy and endoscopic enteral metal stent (ES) placement. Endoscopic approaches are less invasive, allow earlier oral intake, and reduce hospital stay \[4-6\]. Considering that most patients with malignant GOO are debilitated, a less invasive option is often preferable. In recent years, endoscopic ultrasound-guided gastroenterostomy (EUS-GE) has emerged as an alternative. A recent systematic review and meta-analysis comparing ES and EUS-GE found similar technical and clinical success rates, but significantly lower re-intervention rates in the EUS-GE group \[7\]. However, most existing studies are retrospective and lack systematic, prospective follow-up data comparing the two approaches remain lacking. This study aims to prospectively evaluate and compare the short- and long-term outcomes-including stent function, oral intake, nutritional status, and quality of life-of patients with malignant GOO undergoing either EUS-GE or conventional enteral stenting.

Evaluate the Detection of Retained Gastric Contents and Assess Safety Using the Flower Capsule Endoscopy in Healthy Individuals and GLP-1 Receptor Agonist Users

Clinical Study Overview Feasibility Study Plan (Study 1: Healthy Participants) Study 1- Confirming Flower capsule performance characteristics in detection of retained gastric contents greater than 1.5mL/kg in Healthy volunteers 1\. Study Purpose a. A controlled, prospective, between-participants study design to assess Flower in detecting the presence or absence of retained gastric contents (RGC), using sedated esophagogastroduodenoscopy (EGD) as the ground truth for an empty stomach and known ingested volume as the ground truth for a fed participant. 2\. Study Endpoints a. Primary i. Visualization of Retained Gastric Contents b. Secondary i. Gastric mucosal visualization of the seven anatomical landmarks of the stomach (fundus, cardia, lesser gastric curvature, greater gastric curvature, angulus, antrum, and pylorus) ii. Gastric Cleanliness iii. Adverse events defined as capsule retention, capsule aspiration, perforation, nausea, and pain iv. Maximum, tolerated water consumed v. Patient tolerance vi. Exploratory attempts for successful swallowing vii. Exploratory minimum and maximum water volume for optimal Flower performance viii. Time required for gastric examination completion by Flower