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NCT Number: NCT07488299

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

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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Key information

Conditions

Pancreatic Walled-off Necrosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Total number of interventions

    Time frame: 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 outcomes

  1. Technical Success Rate

    Time frame: With 24 hours after EUS-TD

    Successfully placed stents to drain WON.

  2. Clinical success rate

    Time frame: 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.

  3. Stent occlusion rate

    Time frame: 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.

  4. Hospitalization and cost

    Time frame: Within 6 months after EUS-TD

    The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment

  5. Incidence of complications

    Time frame: Within 6 months after EUS-TD

    Bleeding, perforation, secondary infection, incidence and duration of new organ dysfunction, and mortality associated with EUS-TD.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhen Li, MD

CONTACT

[email protected]

18560086106

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
  • Nanfang Hospital, Southern Medical University
  • Shandong Provincial Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shengli Oilfield Hospital
  • Shenzhen People's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.