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| Name | Class |
|---|---|
| 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
| Shandong Provincial Hospital | OTHER_GOV |
| Shengli Oilfield Hospital | OTHER |
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In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis 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 inhibitor 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| receive continuous proton pump inhibitor therapy following EUS-TD | Experimental |
| |
| No PPI therapy following EUS-TD | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Pump Inhibitors | Drug | On the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of interventions | 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. | Within 6 months after EUS-TD |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Successfully placed stents to drain WON. | With 24 hours after EUS-TD |
| Clinical success rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li, MD | Contact | 18560086106 | qilulizhen@sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ning Zhong, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250063 | China |
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| ID | Term |
|---|---|
| D054328 | Proton Pump Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Shenzhen People's Hospital |
| OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
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| Within 1 months after EUS-TD |
| Stent occlusion rate | 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. | Within 6 months after EUS-TD |
| Hospitalization and cost | The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment | Within 6 months after EUS-TD |
| Incidence of complications | Bleeding, perforation, secondary infection, incidence and duration of new organ dysfunction, and mortality associated with EUS-TD. | Within 6 months after EUS-TD |