Comparing two methods for treating walled-off pancreatic necrosis
Direct Endoscopic Necrosectomy Versus Endoscopic Step-up Approach After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
NA · Chinese University of Hong Kong · NCT05252897
This study is testing which of two treatment methods works better for people with walled-off pancreatic necrosis after they have had drainage, to see if one helps them feel better faster and needs fewer follow-up procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 9 sites (Adelaide and 8 other locations) |
| Trial ID | NCT05252897 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of direct endoscopic necrosectomy (DEN) compared to the endoscopic step-up approach for treating walled-off pancreatic necrosis (WON) after endoscopic drainage. Patients with suspected or confirmed infected WON will undergo endoscopic drainage using lumen-apposing metal stents (LAMS) and will be randomly assigned to one of the two treatment methods. The study aims to determine which approach leads to better clinical outcomes, including faster resolution of WON and fewer subsequent necrosectomies. It is a multicenter international randomized controlled trial involving several hospitals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with diagnosed walled-off pancreatic necrosis who are symptomatic or have confirmed infection.
Not a fit: Patients who have previously undergone invasive interventions for necrotizing pancreatitis or those with acute flare-ups of chronic pancreatitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced mortality rates for patients with walled-off pancreatic necrosis.
How similar studies have performed: Previous studies have shown promising results for similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Adelaide and 8 other locations
- Royal Adelaide Hospital — Adelaide, Australia (RECRUITING)
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
- Medanta Institute Of Digestive & Hepatobiliary Sciences — Haryāna, India (RECRUITING)
- Asian Institute of Gastroenterology — Hyderabad, India (RECRUITING)
- Deenanath Mangeshkar Hospital & Research Centre — Pune, India (RECRUITING)
- Asan Medical Centre — Asan, South Korea (RECRUITING)
- SoonChunHyang University School of Medicine — Asan, South Korea (RECRUITING)
- Hospital Universitario Rio Hortega — Valladolid, Spain (RECRUITING)
- King Chulalongkorn Memorial Hospital — Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Shannon Chan
- Email: shannonchan@surgery.cuhk.edu.hk
- Phone: 852-35052627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatic Necrosis, walled off pancreatic necrosis, endoscopic drainage, direct endoscopic necrosectomy, endoscopic step up approach