Necrosectomy With Cryotechnology for Accelerated Removal
NCT Number: NCT06553651
Acronym: NECTAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Necrosis|Acute Pancreatitis|Acute Pancreatic Necrosis|Necrosis|Necrosis Pancreas|Walled-Off Pancreatic Necrosis
Interventions: DEVICE: Cryotechnology Necrosectomy Procedure
Sponsor: Christopher C. Thompson, MD, MSc
Collaborators: Erbe Elektromedizin GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2026-01-30
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

Summary:
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.

Primary Outcome Measures: 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., Baseline, Follow-up Visit Day 21
Secondary Outcome Measures: 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., Procedure Day 0, Follow-up Visit 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., Procedure Day 0, Reintervention (if needed)|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., From Procedure Day 0 through Follow-up Visit Day 21|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., Baseline, Procedure Day 0, up to 3 days post-procedure|Duration of Hospital Stay, To assess the impact of cryotechnology on the length of hospital stay, measured from the index intervention to discharge in days., From Procedure Day 0 through date of discharge|Quality of Life (QOL), Evaluate QoL improvement using the 12 question Short Form survey (SF-12) scores from baseline to 21 (+/- 7) days post-last cryo debridement. Scores range from 0-100. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health., Baseline, Follow-up Day 21