Necrosectomy With Cryotechnology for Accelerated Removal

Launched by CHRISTOPHER C. THOMPSON, MD, MSC · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method for removing damaged tissue from the pancreas in patients with a condition called pancreatic necrosis, which can occur after severe pancreatitis. The usual procedure, called direct endoscopic necrosectomy (DEN), uses various tools to remove this unhealthy tissue, but those tools can sometimes struggle to grasp the sticky tissue effectively. In this trial, researchers will use a special tool called a cryoprobe, which freezes the necrotic tissue, making it easier to remove. The goal is to see if this new method is safer and more effective than the traditional tools.

To participate in this trial, you need to be at least 18 years old and have symptoms related to pancreatic necrosis due to acute pancreatitis. You should have imaging results showing a significant amount of necrotic tissue in your pancreas and be willing to undergo multiple endoscopic procedures. If you join the study, you can expect to undergo the DEN procedure with the cryoprobe and will need to attend follow-up appointments to monitor your recovery. This trial is important because it could lead to better treatments for patients facing this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects aged 18 years and above, inclusive of both males and females.
• • Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
• • Imaging indicative of ≥30% necrotic material within the pancreas.
• • Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
• • Subjects able to tolerate repeated endoscopic procedures.
• • Capacity for providing informed consent.
• • Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
• Exclusion Criteria:
• • Inability to provide informed consent.
• • Unwillingness to undergo repeated endoscopies.
• • Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
• • Intervening gastric varices or unavoidable blood vessels within the access tract.
• • Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
• • Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
• • Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
• • Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.