20 Participants Needed

Cryotechnology for Pancreatic Necrosis

(NECTAR Trial)

SG
MR
MB
Overseen ByMichele B. Ryan, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Christopher C. Thompson, MD, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants temporarily stop using dual antiplatelet therapy or therapeutic anticoagulation if they are taking these medications.

What data supports the effectiveness of the Cryotechnology Necrosectomy Procedure treatment for pancreatic necrosis?

Cryosurgery, a similar treatment, has shown better results than chemotherapy for advanced pancreatic cancer, with a 1-year survival rate over 50%. Additionally, cryonecrosis in rats showed that the treated area healed well without causing permanent damage.12345

How is the Cryotechnology Necrosectomy Procedure treatment different from other treatments for pancreatic necrosis?

The Cryotechnology Necrosectomy Procedure is unique because it uses extremely low temperatures to treat pancreatic necrosis, which can lead to the formation of fibrous tissue without causing irreversible damage. This approach is different from traditional methods as it involves freezing the affected tissue, which is then naturally replaced by the body, potentially offering a less invasive alternative to surgery.34678

What is the purpose of this trial?

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.

Research Team

Christopher C. Thompson, MD - Brigham ...

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Eligibility Criteria

This trial is for individuals with severe pancreatitis leading to dead pancreatic tissue, a condition known as necrosis. Participants should be candidates for an endoscopic procedure to remove this tissue. There's no specific mention of exclusion criteria in the provided information, so general health status and other factors will likely be assessed on a case-by-case basis.

Inclusion Criteria

Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days
Imaging indicative of ≥30% necrotic material within the pancreas
My pancreatic necrosis is 6 cm or larger.
See 3 more

Exclusion Criteria

I am unable to understand or sign the consent form.
My doctor thinks an endoscopy could be unsafe for me.
Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo direct endoscopic necrosectomy using cryoprobes to remove necrotic pancreatic tissue

Procedure Day 0
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and technical success

21 days
Follow-up Visit Day 21

Reintervention (if needed)

Additional interventions may be required to achieve treatment success

Up to 21 days

Treatment Details

Interventions

  • Cryotechnology Necrosectomy Procedure
Trial Overview The study tests a new way to perform necrosectomy using cryotechnology—a method that freezes and removes dead pancreatic tissue during an endoscopic procedure. It compares the effectiveness and safety of this approach against traditional methods like forceps or snares.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Cryotechnology Necrosectomy ProcedureExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Christopher C. Thompson, MD, MSc

Lead Sponsor

Trials
6
Recruited
5,300+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials
14
Recruited
840+

Findings from Research

A new surgical technique for treating severe acute pancreatitis with necrosis was performed on 60 patients, showing a mortality rate of 25%.
This technique offers an alternative approach to surgery for this serious condition, indicating potential for further exploration and improvement in patient outcomes.
[Surgical technique for the treatment of the serious acute necrotic pancreatitis in the National Hospital Edgardo Rebagliati Martins].Barreda Cevasco, LA., Targarona Modena, J., Rodriguez Alegría, C.[2006]
In patients with necrotizing pancreatitis, surgical removal of necrotic tissue combined with hypothermic continuous peritoneal lavage-drainage significantly reduced mortality rates to 26%.
This modified treatment approach, developed since 1976, demonstrates improved outcomes compared to the historically high mortality rates in non-operated patients.
[Pancreatic resection and hypothermic peritoneal irrigation in the treatment of patients with necrotizing pancreatitis].Glavas, M., Drazinić, I., Bucconi, S., et al.[2016]
In a study involving rats, cryonecrosis induced in one-third of the pancreas using liquid nitrogen did not lead to irreversible damage, as blood sugar levels remained normal throughout the observation period.
The treated pancreatic area showed significant shrinkage and was replaced by fibrous tissue within 30 days, with no signs of complications like autolysis or pseudocysts, indicating a potential for safe therapeutic applications.
[Anatomo-pathological study of the evolution of cryonecrosis in the rat pancreas].Balbo, G., Meda, E., Barbero, C., et al.[2013]

References

[Surgical technique for the treatment of the serious acute necrotic pancreatitis in the National Hospital Edgardo Rebagliati Martins]. [2006]
[Pancreatic resection and hypothermic peritoneal irrigation in the treatment of patients with necrotizing pancreatitis]. [2016]
[Anatomo-pathological study of the evolution of cryonecrosis in the rat pancreas]. [2013]
Clinical Practice Guidelines for Cryosurgery of Pancreatic Cancer: A Consensus Statement From the China Cooperative Group of Cryosurgery on Pancreatic Cancer, International Society of Cryosurgery, and Asian Society of Cryosurgery. [2018]
Necrosectomy by lavage in the surgical treatment of severe necrotizing pancreatitis. Results in 263 patients. [2010]
Cryoscience and cryomedicine: new mechanisms of biological tissue injury following low temperature exposure. Experimental study. [2016]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The experience of cryomodelling of the pancreas pathology]. [2011]
The necrotizing effect of pulse cryocycling on liver tissue. [2005]
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