Necrosectomy With Cryotechnology for Accelerated Removal of Pancreatic Necrosis

What this Trial Is About

Pancreatic necrosis is a severe complication of acute pancreatitis involving the irreversible death of pancreatic tissue, which can lead to infections and higher risk of death. This trial evaluates the use of cryotechnology in direct endoscopic necrosectomy DEN to remove necrotic pancreatic tissue. Cryoprobes use extremely cold temperatures to freeze and adhere to necrotic tissue, potentially improving removal compared to traditional tools like forceps and snares. The study aims to assess the safety and effectiveness of this cryoprobe method in treating pancreatic necrosis. Participants will undergo DEN using a 1.7 mm flexible cryoprobe that freezes and extracts necrotic tissue from the pancreatic cavity. Up to four cryotechnology procedures may be performed per participant, with the goal of significantly removing debris and improving symptoms of walled-off pancreatic necrosis WOPN. This procedure is minimally invasive and performed with an endoscope, similar to standard clinical care but using the cryoprobe instead of traditional tools. During the study, participants will be monitored through baseline and follow-up visits up to 21 days after the procedure. Researchers will evaluate technical success, safety, procedure time, number of reinterventions, clinical improvement within 72 hours, hospital stay duration, and quality of life. Participants must attend follow-up assessments and be able to tolerate repeated endoscopies. The study provides detailed monitoring of outcomes and any procedure-related adverse events to assess the cryoprobes role in pancreatic necrosis treatment.

Necrosectomy With Cryotechnology for Accelerated Removal