Cryotechnology for removing necrotic pancreatic tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of cryotechnology in conjunction with direct endoscopic necrosectomy (DEN) to enhance the removal of necrotic pancreatic tissue in patients suffering from pancreatic necrosis due to acute pancreatitis. The procedure aims to improve the effectiveness of current endoscopic methods, which often struggle with sticky necrotic tissue. Participants will undergo repeated endoscopic procedures to assess the efficacy and safety of this innovative approach. The study is designed to provide insights into better management strategies for a condition that carries significant morbidity and mortality.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christopher C. Thompson, MD, MSc — Brigham and Womens Hospital
• Study coordinator: Michele Ryan, MS
• Email: mryan@bwh.harvard.edu
• Phone: 617-525-8266

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nasojejunal versus oral feeding after endoscopic drainage of walled-off pancreatic necrosis

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• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

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  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07322978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.