An interventional study of Cryotechnology Necrosectomy Procedure in Pancreatic Necrosis, Acute Pancreatitis and Acute Pancreatic Necrosis, sponsored by Christopher C. Thompson, MD, MSc. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Christopher C. Thompson, MD, MSc · Not applicable, Interventional, and Treatment
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.
Acute pancreatitis is the most common gastrointestinal disease requiring acute hospital admission. Pancreatic necrosis, a serious complication of acute pancreatitis, is the irreversible death of pancreatic tissue and, in some cases, surrounding abdominal tissue. Worldwide, the incidence of acute pancreatitis ranges from 13 to 45 cases per 100,000 people per year, with a subset progressing to necrotizing pancreatitis. Approximately 5-10% of acute pancreatitis cases progress to this severe form, which carries a significant morbidity and mortality burden, with mortality rates escalating to as high as 32% in cases complicated by infection. The management of pancreatic necrosis is challenging and requires several therapeutic interventions to mitigate the high morbidity and mortality associated with this condition.
The treatment of pancreatic necrosis includes several therapeutic strategies, each with varying degrees of invasiveness, efficacy, and associated risks:
Surgical debridement: Traditionally, surgical debridement has been the cornerstone of treatment for pancreatic necrosis, with the goal of removing necrotic tissue. Although effective, this approach is associated with significant risks, including high morbidity and mortality rates, as high as 39% in some studies. Surgical debridement is a very invasive procedure and often not suitable for patients with severe pancreatitis and their often compromised health status.
Percutaneous Catheter Drainage (PCD): A less invasive alternative to surgery, PCD facilitates drainage of infected necrotic fluid collections. However, its effectiveness is limited by its inability to effectively remove solid necrotic debris. This limitation often requires additional interventions or procedures.
Endoscopic necrosectomy: This minimally invasive technique involves the endoscopic removal of necrotic tissue through the stomach or duodenum. Endoscopic necrosectomy, particularly when used in a step-up approach that may combine PCD with endoscopic drainage and debridement, has been shown to reduce morbidity compared to surgery. Despite the better outcome of the endoscopic technique, there is a gap in effective devices for necrotic tissue removal. Primarily, devices that are utilized include polypectomy snares, biliary baskets, food bolus nets (Roth nets), and forceps. As they are not designed for this indication, their use is often sophisticated and not always successful. As a result, fragmentation and removal as well as a complete debridement of the necrotic tissue is not always achieved, and multiple sessions are required. In a large multicenter trial in the United States, the total number of interventions ranged from 3.1 (immediate direct endoscopic necrosectomy DEN) to 3.9 (delayed DEN). This reflects a significant limitation in the current management of pancreatic necrosis and requires alternative approaches.
Cryotechnology:
In contrast to conventional methods, cryotechnology provides a method for obtaining large tissue samples by utilizing the Joule-Thompson effect for the production of extremely cold temperatures at the probe tip.This involves the internal flow of carbon dioxide (CO2) from a high pressure source to a small nozzle at the tip of the instrument where it expands. The gas expansion causes a large temperature drop (Joule-Thomson effect) and as a result, the surrounding instrument tip is cooled. The expanded gas is returned internally from the tip to the cryosurgical unit via the return tube.
This technology is widely available and used in endoscopy, particularly in the field of pulmonology. Cryoprobes are flexible endoscopic instruments that are currently available in different diameters, 1.1 mm, 1.7 mm, and 2.4 mm. The longstanding safety and efficacy profile have demonstrated results in the safe and efficient management of the following clinical applications, biopsy, extraction and devitalization. They are intended for applications such as the removal of foreign bodies, mucus plugs, blood clots, necrotic tissue, tissue tumors (palliative recanalization) and tissue biopsies. Tissue samples obtained with this technique (cryoadhesion) have been shown to be heavier and larger than those obtained with conventional forceps.
Potential for Pancreatic Necrosis and Significance:
The successful implementation of cryotechnology for extraction suggests its potential applicability for pancreatic necrosectomy. The use of cryoprobes for minimally invasive endoscopic removal of necrotic pancreatic tissue may represent a novel approach that overcomes the limitations of existing strategies. The ability of cryotechnology to secure larger tissue samples without significant bleeding risks, coupled with its safety profile, provides an opportunity to improve the management of necrotizing pancreatitis. This study aims to investigate the safety, efficacy, and feasibility of cryoprobe use for the endoscopic removal of necrotic tissue, setting the stage for future clinical advances in the management of necrotizing pancreatitis.
74 studies on the registry are indexed under Pancreatitis, Acute Necrotizing; 19 are open to participants now.
This study's planned enrollment of 20 is below the median of 70 across 47 interventional studies indexed under Pancreatitis, Acute Necrotizing.
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Enrolled subjects will undergo direct endoscopic necrosectomy using 1.7 mm single use, flexible cryoprobes, aimed at effectively removing necrotic tissue within the pancreatic cavity.
Device: Cryotechnology Necrosectomy Procedure
Subjects 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.
Also known as: Cryotherapy
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.
Time frame: Baseline, Follow-up Visit Day 21
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Follow-up Day 21
Plan to share: Yes — Individual Participant Data (IPD) will be shared on a case by case basis with an Institutional data transfer agreement in place.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: 12 months after publication
Access criteria: IPD requests should be made directly to the PI who will determine feasibility of the request. Institutional data transfer agreement will need to be executed to share data.
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Christopher C. Thompson, MD, MSc