Acute pancreatitis
Conditions
Interventions
Intervention 1: Intervention group ("immediate" necrosectomy): Patients at this group will have endoscopic necrosectomy at the time of stent placement. The necrotic collection is identified with endos
then transmural placement of cystogastrostomy stent under EUS guidance is performed. The type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at the dis
then, direct endoscopic necrosectomy is performed with CO2 insufflation for 45 to 90 minutes. Intervention 2: Control group ("immediate" necrosectomy): For patients in this group, endoscopic necrosect
then transmural placement of cystogastrostomy stent under EUS guidance is performed. Again, the type of stent, either "double pigtail plastic stent" or "lumen apposing metallic stent", is selected at
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Definite diagnosis of walled-off pancreatic necrosis At least 20% solid component at the necrotic lesion
Exclusion criteria
Exclusion criteria: Uncorrectable coagulopathy with platelet count 1.5 Location of the infected walled-off pancreatic necrosis is unreachable with endosonography Pregnancy (in females) Prior intervention on the infected walled-off pancreatic necrosis (such as cutaneous drainage, ...)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Size of infected walled-off pancreatic necrosis. Timepoint: 1 month and 3 months. Method of measurement: Abdominal computerized tomography (CT) scan.;Clinical symptoms and signs related to the infected walled off pancreatic necrosis. Timepoint: 1 months and 3 months. Method of measurement: Patient interview. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival after 3 months. Timepoint: 3 months after stent placement. Method of measurement: Interview with the patient or his/her relatives.;Rate of newly-diagnosed diabetes. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Laboratory evaluation (blood glucose).;Complications after endoscopic necrosectomy. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Clinical evaluation and reviewing the patient's medical records.;Length-of-stay in hospital. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records.;Number of necrosectomy sessions. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records.;Mean time of necrosectomies. Timepoint: 1 month and 3 months after stent placement. Method of measurement: Reviewing the patient's medical records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Hassanzadeh
Iran University of Medical Sciences
Outcome results
None listed