Endoscopic Low-Thermal Argon Plasma Treatment Compared to Standard Care for Marginal Ulcers After Gastric Bypass Surgery

What this Trial Is About

Researchers are investigating the use of Low Thermal Plasma LTP treatment for marginal ulcers that develop at the site of Roux-en-Y gastric bypass surgery. These ulcers are internal wounds that can be slow to heal and cause complications like pain, bleeding, and the need for surgery. The study aims to compare this new minimally invasive plasma treatment with the current standard care using proton pump inhibitors PPIs, hoping to improve healing and reduce the risks associated with more invasive surgical options. Participants will be randomly assigned to receive either the LTP treatment plus standard PPI therapy or standard PPI therapy alone. The LTP treatment involves applying low power argon plasma during an endoscopic procedure to the ulcerated areas to promote healing. If ulcers in the standard care group do not heal after 8 weeks, patients may crossover to receive the LTP treatment. Treatments and evaluations will occur at baseline, 4 weeks, and 8 weeks. Throughout the study, participants will undergo endoscopic examinations to measure ulcer healing, tissue oxygenation, gastrointestinal symptoms, and quality of life. Researchers will monitor for any procedure-related adverse events up to 8 weeks. The main outcome is the ulcer healing success rate measured by endoscopy. Participants will attend follow-up visits to assess healing progress and other clinical improvements during the approximately 8-week study period.

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment