Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

Launched by CHINESE UNIVERSITY OF HONG KONG · Feb 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for treating a serious condition called walled-off pancreatic necrosis (WON), which can happen after pancreatitis and may cause severe illness. The trial compares a standard approach, where doctors first drain the area and then perform surgery if needed, to a newer method where doctors do surgery right away while placing a drain. The goal is to see which method helps patients recover faster and requires fewer surgeries.

To participate in this trial, you need to be an adult over 18 years old with a confirmed diagnosis of WON, typically seen on imaging tests. You should also have symptoms like ongoing pain, nausea, or weight loss due to this condition. However, there are some reasons you might not be eligible, such as having had previous surgeries for similar issues or being pregnant. If you join the study, you can expect close monitoring and care from the medical team as they gather information on your recovery with either treatment method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult (≥18 years of age) patients
• • 2. Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5
• • 3. Documented history of acute pancreatitis
• • 4. Suspected or confirmed infected WON and/or symptomatic WON causing (i) persistent pancreatic-type pain, and/or ii) gastric outlet or biliary obstruction, and/or (iii) ongoing systemic illness, anorexia, and weight loss, and/or (iv) rapidly enlarging WONs, and/or (v) infected WON\*
• • 5. WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage
• • 6. WON with a solid component \>30% and/ or percentage of necrosis \>= 30%
• Exclusion Criteria:
• • 1. Previous invasive interventions for necrotising pancreatitis
• • 2. An acute flare up of chronic pancreatitis
• • 3. Recurrent acute pancreatitis
• • 4. Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)
• • 5. Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases
• • 6. WON not adherent to the GI wall or not accessible for endoscopic drainage
• • 7. Coagulopathy (INR \>1.5), and/or thrombocytopenia (platelets \<50,000/mm3)
• • 8. Pregnancy