Surgical vs Endoscopic Resection of Walled Off Pancreatic Necrosis Using the Powered Endoscopic Debridement System

Launched by STANFORD UNIVERSITY · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for a condition called walled-off necrosis (WON), which can happen after severe pancreatitis, a painful inflammation of the pancreas. The researchers want to find out if a newer method called endoscopic necrosectomy (DEN) using a special powered tool is just as effective and safe as traditional surgery (transgastric surgical necrosectomy or SN) for treating this condition. They will compare how well each method works, the costs involved, the length of hospital stays, and how satisfied patients are with their treatment.

To participate in the trial, you need to be an adult who has symptoms from WON due to acute pancreatitis and is eligible for either treatment option as determined by a team of specialists. Participants will be randomly assigned to receive one of the two treatments and will be monitored closely for any complications. They will also complete assessments before and after the procedure to see how well they are doing. It's important to know that the trial is not yet recruiting participants, but it aims to help improve treatment options for people suffering from this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients 18 years of age or greater.
• • Patients with first episode of symptomatic WON+ due to acute pancreatitis (+Persistent fatigue, malaise, abdominal pain, gastric outlet obstruction, early satiety, fever, chills, jaundice, reduced appetite, persistent nausea/vomiting, steatorrhea)
• • Patients who are candidates for surgical or endoscopic necrosectomy of WON as deemed by a multidisciplinary committee of HPB surgeons and therapeutic endoscopists.
• • Patients who can tolerate repeat procedures.
• • Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
• Exclusion Criteria:
• • Documented untreated pseudoaneurysm within WON.
• • Subject unable or unwilling to provide informed consent.
• • Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using pre-procedural imaging).
• • Coagulation disorders or anti-coagulant therapy which cannot be discontinued for the intervention to an absolute cardiac or vascular indication such as ACS, Stroke, Mechanical cardiovascular valves.
• • Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• • Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
• • Non-communicating pancreatic or extra-pancreatic fluid collections.
• • Extensive abdominal surgical history due to peritoneal adhesions, prior open or recent operation during pancreatitis course, or remote gastric surgery that precludes a transgastric surgical cystgastrostomy.