NECTARCryotechnology for Pancreatic Necrosis
Cryotechnology Necrosectomy Procedure
Digestive System Diseases+4
+ Necrosis
+ Pancreatic Diseases
Treatment Study
Summary
Study start date: January 1, 2026
Actual date on which the first participant was enrolled.Acute pancreatitis is a common and serious condition that sometimes leads to pancreatic necrosis, where parts of the pancreas die. This study focuses on improving the treatment for pancreatic necrosis, which can be life-threatening and difficult to manage with existing methods. Traditional treatments like surgery carry high risks, and other less invasive options may not effectively remove all the dead tissue, often requiring multiple procedures. This study is exploring the use of cryotechnology, which involves using extremely cold temperatures to remove tissue, as a potentially safer and more effective method to treat pancreatic necrosis. In this study, participants with pancreatic necrosis will undergo a procedure using cryoprobes, which are special instruments that use cold temperatures to remove dead pancreatic tissue. The process is minimally invasive and performed through endoscopic techniques. The study aims to measure how well cryotechnology works in safely removing necrotic tissue and whether it reduces the need for multiple procedures. Researchers are particularly interested in its ability to obtain larger tissue samples without causing significant bleeding, which could make it a better option for managing this serious condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location