Inca

Researchers are evaluating if the drug eRapa can slow the progression of Familial Adenomatous Polyposis FAP, a condition characterized by the development of numerous polyps in the gastrointestinal tract. This Phase 3 trial compares eRapa to a placebo to understand its impact on disease progression, safety, number of polyps, and patients quality of life. The study involves patients at high risk of disease progression under active surveillance with specific colon or post-surgical conditions. Participants will be randomly assigned to receive either 0.5 mg of eRapa or a matching placebo orally once daily every other week. The treatment continues until disease progression, withdrawal, or trial endpoint. Patients will have baseline and follow-up endoscopies every 6 months to monitor disease status, with visits every 3 months for check-ups and tests. Stratification will consider colon status and duodenal polyposis severity. During the study, participants will attend clinic visits approximately every 3 months for assessments, including endoscopies to evaluate disease progression. Researchers will measure progression-free survival over three years, safety and tolerability of eRapa, effects on GI polyposis and Spigelman stage score, and quality of life using standardized questionnaires. The trial is designed to monitor participants closely for changes and treatment effects over time.

Crohns disease CD often leads to stenosis, a common complication that increases risks like repeated surgery and short bowel syndrome. This study focuses on patients with new de novo stenosis less than 10 cm in length, seeking to compare the effectiveness, complications, quality of life impact, and costs of surgical versus endoscopic treatments. There is currently no clear scientific evidence guiding the best treatment choice for these patients. The study compares two endoscopic treatmentsendoscopic balloon dilation EBD and self-expanding metal stents SEMSagainst surgical resection for managing de novo stenosis in CD. Participants in the endoscopic groups receive either pneumatic balloon dilations up to twice with intervals or placement of fully coated metal stents for four weeks. Surgical resection is also evaluated, with all procedures including post-procedural monitoring in a Short Stay Unit and sedation as appropriate. Participants will be followed for one year, during which their quality of life, clinical recurrence, and complications will be assessed. Evaluations include endoscopic and radiological tests to confirm stenosis and ongoing monitoring of symptoms. The study also considers treatment costs and long-term efficacy. The overall aim is to better understand which treatment approach offers the best balance of safety, effectiveness, quality of life, and cost for patients with CD-related stenosis.