Luso-Cor Stent Compared to Other Endoscopic Techniques for Management of Fistulas and Anastomotic Dehiscences(ES-LCCE-UDFM)
Launched by UNIDADE LOCAL DE SAÚDE SANTA MARIA · Mar 3, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The morbidity and mortality related to adverse events increases with surgical re-exploration at the site of a fistula orifice. For this reason, management of fistulas after bariatric surgery has shifted from a surgical to a primarily endoscopic approach, primarily with covered metallic stents, with fistula closure success rates between 75% and 100%. However, a primarily endoscopic approach is demanding in terms of resource use, and the high incidence of stent migration often requires multiple reinterventions - both endoscopically and surgically.
The Luso-Cor esophageal stent was designed t...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients undergoing endoscopic management of fistulas after bariatric surgery or dehiscences of esophago-jejunal or gastro-jejunal anastomosis after esophageal or gastric oncologic surgery will be included in the study.
- Exclusion Criteria:
- • Pregnancy
- • Age \< 18years
- • Inability to give informed consent.
About Unidade Local De Saúde Santa Maria
Unidade Local de Saúde Santa Maria (ULSSM) is a prominent healthcare provider dedicated to delivering high-quality medical services and advancing clinical research. Located in Portugal, ULSSM focuses on enhancing patient care through innovative treatment approaches and rigorous scientific investigation. The organization actively engages in clinical trials that aim to evaluate new therapies and improve existing healthcare practices, fostering collaboration between healthcare professionals, researchers, and patients. ULSSM is committed to adhering to ethical standards and regulatory requirements, ensuring the safety and well-being of participants while contributing to the advancement of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lisbon, , Portugal
Patients applied
Trial Officials
Carlos Noronha Ferreira, MD, MSc, PhD
Principal Investigator
Serviço de Gastrenterologia e Hepatologia, Unidade Local de Saúde Santa Maria
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported