RECRUITING

Necrosectomy With Cryotechnology for Accelerated Removal

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Necrosectomy With Cryotechnology for Accelerated Removal

Quick Facts

Study Start:2025-02
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06553651

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects aged 18 years and above, inclusive of both males and females.
  2. * Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.
  3. * Imaging indicative of ≥30% necrotic material within the pancreas.
  4. * Walled-off pancreatic necrosis (WOPN) size ≥6 cm.
  5. * Subjects able to tolerate repeated endoscopic procedures.
  6. * Capacity for providing informed consent.
  7. * Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+/- 7) days.
  1. * Inability to provide informed consent.
  2. * Unwillingness to undergo repeated endoscopies.
  3. * Presence of documented Pseudoaneurysm \> 1cm within the WOPN.
  4. * Intervening gastric varices or unavoidable blood vessels within the access tract.
  5. * Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.
  6. * Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
  7. * Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
  8. * Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.

Contacts and Locations

Study Contact

Michele Ryan, MS
CONTACT
617-525-8266
mryan@bwh.harvard.edu
Samantha Geltz
CONTACT
617-732-5174
sgeltz@bwh.harvard.edu

Principal Investigator

Christopher C. Thompson, MD, MSc
PRINCIPAL_INVESTIGATOR
Brigham and Womens Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Christopher C. Thompson, MD, MSc

  • Christopher C. Thompson, MD, MSc, PRINCIPAL_INVESTIGATOR, Brigham and Womens Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2025-02
Study Completion Date2027-01-30

Terms related to this study

Keywords Provided by Researchers

  • Direct Endoscopic Necrosectomy (DEN)
  • Endoscopic Necrosectomy
  • Pancreatic Necrosectomy
  • Necrosectomy
  • Cryotherapy
  • Cryotechnology

Additional Relevant MeSH Terms

  • Pancreatic Necrosis
  • Acute Pancreatitis
  • Acute Pancreatic Necrosis
  • Necrosis
  • Necrosis Pancreas
  • Walled-Off Pancreatic Necrosis