Health Condition 1: K859- Acute pancreatitis, unspecified
Conditions
Interventions
Intervention1: LAMS with ENCD insertion: Lumen apposing metal stent with endonasal cavity drainage insertion till 8 weeks or resolution of peripancreatic fluid collection
Control Intervention1: LAMS w
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Acute necrotizing pancreatitis with symptomatic WOPN undergoing LAMS. as per revised atlanta classification. 2) Patients with symptoms due to WOPN (e.g. infection, GI symptoms, or jaundice due to biliary obstruction, gastric outlet obstruction, ongoing systemic illness, weight loss, anorexia) 3) WOPN of size of at least 5 cm with = 20% of solid/necrotic component as assessed on EUS/USG/MRI/MRCP 4) Willing and capable to give written Informed consent
Exclusion criteria
Exclusion criteria: Non identification of solid content on EUS during procedure Inability to carry out upper digestive endoscopy Females who are pregnant. Uncorrectable coagulopathy(INR more than 1.5) or thrombocytopenia (Platelet less than 50000) Has surgically altered gastrointestinal anatomy such as but not limited to Billroth II, Roux-en-Y, gastric bypass Use of anticoagulants or dual antiplatelets that cannot be discontinued for the procedure Unable to tolerate general anesthesia or conscious sedation Necrotic collection that is not accessible for EUS-guided drainage Percutaneous drainage of the necrotic collection is required or performed prior to EUS-guided drainage Imaging showing that the pseudocyst wall was not in Close proximity(more than one cm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the median number of endoscopic necrosectomy sessions required in each group to achieve clinical success. - It is defined as resolution of the WON (3cm in size) on cross sectional imaging and resolution of the patient’s symptoms without the need for reintervention at 2 month after initial treatment, as demonstrated by clinic follow-up and cross-sectional imaging. 2. To compare the proportion of clinical success at 2 months.Timepoint: Two months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the median number of endoscopic necrosectomies required in each group.Timepoint: 2 months;To compare the number of days of post procedure ICU stay in each group.Timepoint: 2 months;To compare the number of days post procedure hospital stay in each group.Timepoint: 2 months;To compare the rate of adverse events in each group. a. Perforation-Imaging manifests as pneumoperitoneum with peritoneal signs b. Bleeding -Any bleeding that requires intervention, blood transfusion, and hospital observation c. Infection- Postoperative fever, increased inflammatory index (CRP, PCT), or positive blood culture d. Occlusion-The stent is filled with tissue or debris e. Migration-The stent is completely or partially displaced into the WON or stomach f. Nasocystic tube displacement/ blockage: The NCD gets displaced or blocked after insertion. g. Others- Adverse events that occurred in the trial but not described above.Timepoint: 2 months;To compare the total number of procedures required to achieve clinical success including the index endoscopic intervention, endoscopic reinterventions, percutaneous drain placement, repositioning of NCD.Timepoint: 2 months;Treatment failure was defined as the need for rescue surgery or death due to underlying disease or interventionTimepoint: 2 months | — |
Countries
India
Contacts
Public ContactSahil Gupta
AIIMS Rishikesh
Outcome results
None listed