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Comparing Lumen-apposing Metal Stents with Plastic Stents for Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis:A Multicenter Randomized Controlled Study

Comparing Lumen-apposing Metal Stents with Plastic Stents for Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis:A Multicenter Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122385
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late-stage complications of acute pancreatitis: Encapsulated necrosis of the pancreas

Interventions

LAMS Group:EUS-guided puncture through gastric or duodenal wall into necrotic cavity with placement of LAMS (20mm length, 16mm diameter), with endoscopic debridement of necrotic tissue as needed
if suspected pancreatic duct interruption syndrome, switch to plastic stent according to protocol
DPPS Group:EUS-guided puncture through gastric or duodenal wall into necrotic cavity with placement of double-pigtail plastic stent (DPPS), with endoscopic debridement of necrotic tissue as needed
if suspected pancreatic duct interruption syndrome, leave stent in place indefinitely according to protocol

Sponsors

The first affiliated hostipal of nanchang university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–80 years, no sex restriction; 2. CT or MRI shows WON adjacent to the gastric or duodenal wall; 3. Maximum cross-sectional diameter of the lesion >=6 cm; 4. Presence of at least one of the following symptoms: (1) Obvious compressive symptoms, including abdominal pain, abdominal distension, vomiting, jaundice, etc.; (2) Persistent fever with clinically suspected or confirmed infected walled-off necrosis (confirmed by positive culture of drainage fluid, presence of air bubbles within WON suggestive of infection, or persistent sepsis with no other identifiable cause of infection); (3) Rapid enlargement of the lesion in a short period; 5. Proportion of necrotic debris within the walled-off necrosis >30%; 6. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Coagulation dysfunction (INR > 1.5), thrombocytopenia ( 2 cm); 6. Severe cardiopulmonary disease or other conditions precluding tolerance of the procedure; 7. Pregnant or lactating patients; 8. Previous endoscopic drainage or debridement for WON, or percutaneous drainage performed during the current hospitalization; 9. Imaging findings indicate extensive extension of WON toward the paracolic sulcus and retroperitoneum in the pelvic direction, where endoscopic drainage alone may not achieve adequate debridement; 10. Patients who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Number of endoscopic debridements after stent drainage in the two groups.;

Secondary

MeasureTime frame
Conversion to surgery, mortality, postoperative hospital stay (from the time of puncture drainage to discharge), proportion of patients admitted to the intensive care unit (ICU) after drainage, total;Complications related to operation or stent;Technical success rate;Duration of EUS drainage procedure;Total number of additional interventions required;Clinical success rate;

Countries

China

Contacts

Public ContactZhu Yin

The first affiliated hostipal of nanchang university

zhuyin27@sina.com+86 791 88692748

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026