Pancreatic Walled-off Necrosis
Conditions
Keywords
Pancreatic Walled-off Necrosis, Direct Endoscopic Necrosectomy, Proton Pump Inhibitor, Randomized Controlled Trial, Endoscopic Ultrasound-guided Transluminal Drainage/Debridement
Brief summary
In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis (WON) based on inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either receive intravenous infusion or oral administration of continuous proton pump inhibitors (PPIs) or to undergo no PPI (nPPI) therapy after endoscopic ultrasound-guided transluminal drainage/debridement. Clinical data and patient-reported outcomes will be systematically collected at baseline and during follow-up periods. The study aims to assess whether PPI use after EUS-TD (Endoscopic Ultrasonography-Guided Transmural Drainage) increases the number of direct endoscopic necrosectomies required to managing WON. Additionally, the study will investigate the impact of PPI use on the incidence of stent occlusion and postoperative complications following EUS-TD, as well as its effect on the average duration of hospitalization and associated costs for patients with WON.
Interventions
DRUGProton Pump Inhibitors
On the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration.
Sponsors
Qilu Hospital of Shandong University
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Shandong Provincial Hospital
Shengli Oilfield Hospital
Shenzhen People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years or older and not exceeding 80 years of age. 2. Patients with a confirmed diagnosis of WON. 3. Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy. 4. Patients who have signed informed consent forms.
Exclusion criteria
1. Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months. 2. Patients with severe coagulation disorders (International Normalized Ratio \[INR\] \> 1.5). 3. Patients with significant thrombocytopenia (platelet count \< 50 × 10\^9/L). 4. Pregnant women. 5. Patients undergoing endoscopic drainage solely through the duodenum. 6. Patients with a history of gastrectomy, gastric bypass surgery, or prior surgery for pancreatic-related diseases. 7. Patients currently taking medications that may affect gastric acid secretion or metabolism, such as strong cytochrome P450 (CYP) 3A4 inhibitors (e.g., clarithromycin, itraconazole) or inducers (e.g., rifampin, carbamazepine). 8. Patients requiring long-term use of acid-suppressing medications such as PPIs and P-CABs due to other medical conditions. 9. Patients with a history of acid-suppressive medication use (e.g., PPI) and a washout period of less than 14 days. 10. Patients with documented contraindications to PPIs or a relevant history of hypersensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of interventions | Within 6 months after EUS-TD | The total number of endoscopic interventions required to achieve successful WON treatment, including reinterventions, stents removal, and any other interventions performed during the 6-month follow-up period to manage adverse events or disease-specific events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | With 24 hours after EUS-TD | Successfully placed stents to drain WON. |
| Clinical success rate | Within 1 months after EUS-TD | The lesion size has decreased by more than 50% compared to preoperative measurements, with concurrent symptom relief. No further intervention is required prior to stents removal. |
| Stent occlusion rate | Within 6 months after EUS-TD | The stent lumen is obstructed by necrotic tissue, debris, or blood clots, leading to impaired drainage and necessitating reintervention, such as stent replacement or direct endoscopic necrosectomy. |
| Hospitalization and cost | Within 6 months after EUS-TD | The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment |
| Incidence of complications | Within 6 months after EUS-TD | Bleeding, perforation, secondary infection, incidence and duration of new organ dysfunction, and mortality associated with EUS-TD. |
Countries
China
Contacts
CONTACTZhen Li, MD
PRINCIPAL_INVESTIGATORNing Zhong, MD
Qilu Hospital of Shandong University
Outcome results
None listed