Pancreatic Walled-off NecrosisNCT07488299
The Effect of Proton Pump Inhibitors(PPIs) on Endoscopic Treatment of Walled-off Necrosis (WON)
A study testing Proton Pump Inhibitors in people with Pancreatic Walled-off Necrosis, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Walled-off Necrosis
- What is being tested?
- Proton Pump Inhibitors
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2025to 20 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
Zhen Li, MD, 18560086106, qilulizhen@sdu.edu.cn
About this study
Official title: The Effect of Proton Pump Inhibitors on Endoscopic Treatment of Walled-off Necrosis: a Multicenter Randomized Controlled Trial
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.
- Conditions
- Pancreatic Walled-off Necrosis
- Being tested
- Proton Pump Inhibitors
- Keywords
- Pancreatic Walled-off Necrosis, Direct Endoscopic Necrosectomy, Proton Pump Inhibitor, Randomized Controlled Trial, Endoscopic Ultrasound-guided Transluminal Drainage/Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Pump InhibitorsDrug
On the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration.
| Study group | Role | What they receive |
|---|---|---|
| receive continuous proton pump inhibitor therapy following EUS-TD | Experimental | Not described Receives: Drug: Proton Pump Inhibitors |
| No PPI therapy following EUS-TD | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months after EUS-TD
Secondary outcomes (5)
Technical Success Rate
Successfully placed stents to drain WON.
Measured: 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.
Measured: 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.
Measured: Within 6 months after EUS-TD
Hospitalization and cost
The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment
Measured: 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.
Measured: Within 6 months after EUS-TD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start17 Sep 2025
- Primary completion20 Mar 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Walled-off NecrosisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Ning Zhong, MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488299
- Sponsor's protocol ID
- 2025SDU-QILU-7
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proton Pump Inhibitors on Endoscopic Treatment of Walled-off Necrosis: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07488299
- Acronym / sponsor ID
- 2025SDU-QILU-7
- Conditions
- Pancreatic Walled-off Necrosis
- Keywords
- Pancreatic Walled-off Necrosis, Direct Endoscopic Necrosectomy, Proton Pump Inhibitor, Randomized Controlled Trial, Endoscopic Ultrasound-guided Transluminal Drainage/Debridement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- 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 start
- 17 Sep 2025 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receive continuous proton pump inhibitor therapy following EUS-TD | Experimental | Drug: Proton Pump Inhibitors |
| No PPI therapy following EUS-TD | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Pump InhibitorsOn the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration. | Drug | receive continuous proton pump inhibitor therapy following EUS-TD |
Primary outcome
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.
5 secondary outcomes
Technical Success Rate
Time frame: With 24 hours after EUS-TD
Clinical success rate
Time frame: Within 1 months after EUS-TD
Stent occlusion rate
Time frame: Within 6 months after EUS-TD
Hospitalization and cost
Time frame: Within 6 months after EUS-TD
Incidence of complications
Time frame: Within 6 months after EUS-TD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Walled-off Necrosis
RecruitingObservational study
Management and Outcomes of Local Complications of Acute Pancreatitis and Postoperative Pancreatic Fistula
Acute Pancreatitis, Pancreatic Fluid Collection
Recruiting
Necrosectomy With Cryotechnology for Accelerated Removal
Pancreatic Necrosis, Acute Pancreatitis
Recruiting
Nasojejunal Feeding Versus Oral Feeding Following Endoscopic Drainage of Walled Off Pancreatic Necrosis
Walled Off Pancreatic Necrosis, Acute Pancreatitis (AP)
Recruiting
Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis
Acute Necrotizing Pancreatitis
Not yet recruiting
Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections
Pancreatitis, Walled Off Pancreatic Necrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Zhong, MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton Pump Inhibitors in people with Pancreatic Walled-off Necrosis, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen Li, MD (18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of interventions (time frame: Within 6 months after EUS-TD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.