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.