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Endoscopic transluminal drainage and necrosectomy by using metal stent vs. retroperitoneal debridement under sinus tract endoscopy for infected necrotising pancreatitis: a prospective, randomized controlled study.

Endoscopic transluminal necrosectomy versus percutaneous flexible endoscopic necrosectomy for infected necrotising pancreatitis: a single-center, prospective, randomized controlled study.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024016
Enrollment
Unknown
Registered
2019-06-22
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-06-26

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

Conditions

Acute pancreatitis

Interventions

Group A:Endoscopic transluminal necrosectomy
Group B:percutaneous flexible endoscopic necrosectomy

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 and <85 years; 2. Suspected or confirmed infection of pancreatic necrosis and /or peripancreatic necrosis; 3. The patient has the technical conditions of Endoscopic transluminal drainage and percutaneous catheter drainage.

Exclusion criteria

Exclusion criteria: 1. Severe coagulation dysfunction and other endoscopic contraindications. 2. Pregnant or lactating women; 3. Patients underwent interventional therapy (surgical, endoscopic or percutaneous drainage) for pancreatic necrosis or peripancreatic necrosis before grouping. 4. Indications for emergency laparotomy include intestinal ischemic necrosis, bleeding, perforation of visceral organs, and abdominal compartment syndrome which is difficult to be corrected by conservative treatment. 5. Those who refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Mortality;New-onset organ failure;Enteral-pancreatic cutaneous fistula;Visceral perforation;Intra-abdominal bleeding,;Enterocutaneous fistula;Pancreatic-cutaneous fistula;

Secondary

MeasureTime frame
Exocrine insufficiency;New-onset diabetes;Wound infections;Procedure-related adverse events;Disease-related adverse events;Drainage procedures;Necrosectomies;Additional interventions, endoscopy or surgical interventions are required;Days in ICU within 6 months of randomisation;Days in hospital within 6 months of randomisation;Post-procedural SIRS;Readmissions;

Countries

China

Contacts

Public ContactNonghua Lv

The First Affiliated Hospital of Nanchang University

lunonghua@ncu.edu.cn86-791-88692705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026