The Effect of PPI on Endoscopic Treatment of WON: a Multicenter Randomized Controlled Trial.

Официальное название

The Effect of Proton Pump Inhibitors on Endoscopic Treatment of Walled-off Necrosis: a Multicenter Randomized Controlled Trial.

Обзор

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.

Вмешательства

• Препарат Proton Pump Inhibitors
  On the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration.

Первичные конечные точки

• Total number of interventions [Срок оценки: Within 6 months after EUS-TD]

Вторичные конечные точки (5)

• Technical Success Rate [Срок оценки: With 24 hours after EUS-TD]
• Clinical success rate [Срок оценки: Within 1 months after EUS-TD]
• Stent occlusion rate [Срок оценки: Within 6 months after EUS-TD]
• Hospitalization and cost [Срок оценки: Within 6 months after EUS-TD]
• Incidence of complications [Срок оценки: Within 6 months after EUS-TD]

Критерии участия

Критерии включения

• Patients aged 18 years or older and not exceeding 80 years of age.
• Patients with a confirmed diagnosis of WON.
• Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy.
• Patients who have signed informed consent forms.

Критерии исключения

• Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months.
• Patients with severe coagulation disorders (International Normalized Ratio \[INR\] > 1.5).
• Patients with significant thrombocytopenia (platelet count < 50 × 10\^9/L).
• Pregnant women.
• Patients undergoing endoscopic drainage solely through the duodenum.
• Patients with a history of gastrectomy, gastric bypass surgery, or prior surgery for pancreatic-related diseases.
• 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).
• Patients requiring long-term use of acid-suppressing medications such as PPIs and P-CABs due to other medical conditions.
• Patients with a history of acid-suppressive medication use (e.g., PPI) and a washout period of less than 14 days.
• Patients with documented contraindications to PPIs or a relevant history of hypersensitivity.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT07488299 · 2025SDU-QILU-7

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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