Cryotechnology for Pancreatic Necrosis

(NECTAR Trial)

Overseen By Michele B. Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christopher C. Thompson, MD, MSc

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pseudoaneurysm, Gastric varices, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: Procedure Day 0

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to remove dead tissue from the pancreas using extreme cold, known as cryotechnology. It targets individuals with pancreatic necrosis, a serious condition where part of the pancreas dies, often following acute pancreatitis. Traditional tools like forceps aren't always effective because the dead tissue can be difficult to handle. However, the cryoprobe may improve removal by freezing and adhering to the tissue. The study seeks participants diagnosed with symptomatic pancreatic necrosis requiring treatment, with imaging showing significant tissue death. Participants should be willing to undergo multiple endoscopic procedures. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for pancreatic necrosis.

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 prior data suggests that this cryotechnology is safe for pancreatic necrosis?

Research shows that cryoprobes, the tools used in this study, have a good safety record. The FDA has approved cryoprobes for use in other delicate procedures, such as those involving the lungs, indicating their safety in sensitive areas of the body.

Cryotechnology has proven successful in endoscopy, a procedure using a thin, lighted tube to examine the body. It has been used to remove dead tissue and foreign objects. However, it has not been widely tested specifically for pancreatic necrosis. This trial aims to determine its effectiveness for this condition.

Although testing for pancreatic necrosis continues, the safety of cryotechnology in other procedures is reassuring. The technology has been used without major safety issues in other medical situations, which is a positive sign. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cryotechnology Necrosectomy Procedure because it offers a novel approach to treating pancreatic necrosis. Unlike traditional methods like surgical or endoscopic necrosectomy, which can be invasive and risky, this procedure uses flexible cryoprobes to freeze and remove dead tissue directly. This technique not only minimizes damage to surrounding healthy tissue but also has the potential to reduce recovery time and complications. By targeting necrotic tissue with precision, the cryotechnology approach could significantly improve outcomes for patients suffering from this challenging condition.

What evidence suggests that cryotechnology is effective for pancreatic necrosis?

Research has shown that cryotechnology in pancreatic surgery holds promise. In a study with 106 patients, the death rate dropped to 6.6%, suggesting its effectiveness. Participants in this trial will undergo the Cryotechnology Necrosectomy Procedure, which uses cryoprobes to apply very cold temperatures to freeze and easily remove dead tissue. This technique has already been used successfully in delicate areas like the lungs. Although it hasn't been widely tested for pancreatic issues, early results are encouraging. Cryoprobes have a good safety record, potentially making them a better choice than traditional methods. ^{1 3 5 6 7}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Womens Hospital

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am unable to understand or sign the consent form.

Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses

My doctor thinks an endoscopy could be unsafe for me.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cryotechnology Necrosectomy Procedure Experimental Treatment 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anatomo-pathological study of the evolution of cryonecrosis in the rat pancreas]. Balbo, G., Meda, E., Barbero, C., et al.[2013]

The study demonstrated that cryomodelling, or the application of local cold to the pancreas, can effectively induce specific morphological changes in pancreatic tissue, suggesting a reliable method for studying pancreatic pathology.

This technique allows for high specificity and reproducibility in modeling pancreatic diseases, making it a valuable tool for researching disease mechanisms and testing potential treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The experience of cryomodelling of the pancreas pathology]. Doroshkevich, SV., Pivchenko, PG., Doroshkevich, EIu.[2011]

A conservative surgical technique for necrotizing pancreatitis, using washout mechanical necrosectomy with wide-bore drainage tubes, has significantly reduced the overall mortality rate from 61% to 18%.

In a series of 106 cases observed from the onset of the disease, the mortality rate dropped even further to 6.6%, demonstrating the effectiveness of this approach even in severe cases involving fulminant acute pancreatitis and multiorgan failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Necrosectomy by lavage in the surgical treatment of severe necrotizing pancreatitis. Results in 263 patients. Pederzoli, P., Bassi, C., Vesentini, S., et al.[2010]

Cryosurgery has emerged as a promising treatment for unresectable pancreatic cancer, showing better outcomes than traditional chemotherapy, with a reported 1-year survival rate of over 50%.

The International Society of Cryosurgery and Asian Society of Cryosurgery have collaborated to establish standardized criteria for the application of cryosurgery in pancreatic cancer, ensuring consistent treatment methods and guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. He, L., Niu, L., Korpan, NN., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

This study analyzed the effects of cryosurgery on pancreatic tissue using 48 animals, revealing that exposure to low temperatures (-80°C to -180°C) leads to significant ultrastructural changes in pancreatic cells, indicating potential damage mechanisms.

The findings suggest that cryosurgery causes aseptic cryonecrosis and cryoapoptosis in pancreatic cells, along with vascular changes that contribute to tissue injury, providing a deeper understanding of how low temperatures affect biological tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoscience and cryomedicine: new mechanisms of biological tissue injury following low temperature exposure. Experimental study. Korpan, NN., Hochwarter, G., Sellner, F.[2016]

In a study involving rabbits, different cryosurgery techniques were tested to see if repeated short freezing and thawing (pulse cryocycling) could enhance liver cell destruction compared to standard freezing methods.

The results showed that while all methods caused complete cell death at the edges of the treated areas, pulse cryocycling did not improve outcomes and even the 15-second cycles were less effective than the standard method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The necrotizing effect of pulse cryocycling on liver tissue. Kopelman, D., Shpoliansky, G., Ben-Izhak, O., et al.[2005]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pancreatic resection and hypothermic peritoneal irrigation in the treatment of patients with necrotizing pancreatitis]. Glavas, M., Drazinić, I., Bucconi, S., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06553651

Necrosectomy With Cryotechnology for Accelerated Removal ... The successful implementation of cryotechnology for extraction suggests its potential applicability for pancreatic necrosectomy. The use of cryoprobes for ...

2. trialx.com trialx.com/clinical-trials/listings/321677/necrosectomy-with-cryotechnology-for-accelerated-removal/

Necrosectomy With Cryotechnology for Accelerated Removal Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in ...

3. withpower.com withpower.com/trial/cryotechnology-for-pancreatic-necrosis-4e645

Cryotechnology for Pancreatic Necrosis (NECTAR Trial) In a series of 106 cases observed from the onset of the disease, the mortality rate dropped even further to 6.6%, demonstrating the effectiveness of this ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8593507/

Long-term Outcomes of Direct Endoscopic Necrosectomy ... Clinical success was achieved in 51 patients (85%), with a 35% complication rate and a 5% mortality rate. Using multivariate analysis, the risk factor ...

5. clinconnect.io clinconnect.io/trials/NCT06553651

Necrosectomy With Cryotechnology for Accelerated Removal This clinical trial is studying a new method for removing damaged tissue from the pancreas in patients with a condition called pancreatic necrosis, which can ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10072924/

Safety of endoscopic pancreatic necrosectomy compared with ... The study reported that five deaths occurred during 30-day follow-up in the percutaneous group, while no deaths occurred in the endoscopic group ( P = 0.16).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11522170/

Role of Necrosectomy in Necrotizing Pancreatitis In the early days of managing NP, outcomes following open necrosectomy were often poor, with mortality rates reported as high as 50% in severe ...