Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas.
For this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.
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.
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.
Single group
Cryotechnology Necrosectomy Procedure
DeviceSubjects undergo necrosectomy with 1.7 mm flexible cryoprobes, either concurrently with stent placement or post-placement, at the Investigator's discretion. The cryoprobe will freeze the necrotic tissue and extracted en-bloc. A maximum of 4 cryotechnology procedures will be performed, with each procedure aiming for significant debris removal and clinical improvement of walled-off pancreatic necrosis (WOPN) symptoms.
Technical Success Rate
To evaluate the effectiveness of cryotechnology for the removal of necrotic pancreatic tissue. Achievement of at least 70% removal of necrotic debris from the pancreatic collection being treated, as determined by change in computed tomography (CT) evaluation from baseline to 21 days post-treatment.
Safety and Procedure-Related Adverse Events
To assess the safety profile of using cryotechnology for necrosectomy by monitoring the incidence of intraprocedure-related adverse events, including intracaviteal bleeding during the procedure, aspiration, septic event, and perforation, through follow-up day 21.
Mean Total Procedure Time
To determine the efficiency of cryotechnology for necrosectomy by measuring the mean total procedure time required to achieve at least a 70% reduction in necrosis. Time from first insertion of the cryoprobe into the endoscope to the end of its use (last extraction from the endoscope). The total procedure time for achieving clearance of necrosis will be assessed across all necrosectomy sessions for each patient.
Total Number of Reinterventions
To quantify the necessity for additional interventions by recording the total number of reinterventions per patient required to achieve treatment success.
Clinical Improvement within 72 Hours
To evaluate early clinical improvement, defined as observable patient recovery within 72 hours following the index intervention, improvement in Gastrointestinal Symptom Rating Scale (GSRS) and improvement in c-reactive protein (CRP) labs from baseline. GSRS is seven-point Likert-type scale with 1 being no symptoms, to 7 being worst possible symptoms.
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Christopher C. Thompson, MD, MSc
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Erbe Elektromedizin GmbH
Collaborator
