Immediate vs. On-demand Endoscopic Necrosectomy in Infected Walled-off Pancreatic Necrosis
Pancreatitis, Acute Necrotizing
About this trial
This is an interventional treatment trial for Pancreatitis, Acute Necrotizing
Eligibility Criteria
Inclusion Criteria:
- Documented history of acute pancreatitis
- Necrotic collection with partial or complete wall diagnosed on CT or MRI
- Necrotic collection of any size with any number of loculations with more than 20% of solid/necrotic component
- Necrotic collection is accessible and amenable for EUS-guided drainage
- Age >= 18 years
- Suspected or confirmed infection in the necrotic collection
- The patient understands and accepts to sign the informed consent.
Exclusion Criteria:
- Irreversible coagulopathy with INR>1.5 or platelet counts <50,000
- Necrotic collection is not accessible for EUS-guided drainage
- Females who are pregnant
- Previous intervention (e,g, percutaneous drainage, or surgery) is performed for the patient
Sites / Locations
- Digestive Diseases Research Institute, Shariati Hospital, North Kargar Ave.,Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Immediate endoscopic Necrosectomy
On-demand endoscopic necrosectomy
The subject will have endoscopic necrosectomy at the time of the EUS-guided transmural stent placement. The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. Immediately after stent placement, the cystoenterostomy track is dilated with a 15 mm through the scope (TTS) balloon. Then, direct endoscopic necrosectomy is performed with CO2 insufflation. The duration of necrosectomy will be 30 to 90 minutes. If complete clearance of the cavity is achieved before 30 minutes, the duration of necrosectomy may be less than 30 minutes in the given session. Also, if any complication occurs during necrosectomy, appropriate management will be done, and the procedure may be concluded earlier.
The subject will have EUS-guided transmural drainage of the necrotic collection The necrotic collection is identified with endoscopic ultrasonography (EUS). Transmural placement of stent under EUS guidance is performed. The type of stent is at the discretion of endoscopist. It could be either lumen apposing metallic stent or double pigtail plastic stent. In this group, endoscopic necrosectomy is not performed at the time of index procedure. Such patients may undergo endoscopic necrosectomy during follow up if clinically indicated.