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Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection

Prospective, randomized, multicenter controlled trial for open debridement and lavage and small incision drainage in the treatment of pancreatic pseudocyst complicated with infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027644
Enrollment
Unknown
Registered
2019-11-22
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Pancreatic pseudocyst with infection

Interventions

experimental group:Minimally invasive open external drainage
control group:Open debridement lavage

Sponsors

Department of Pancreatic Surgery, Center of digestive & vascular medicine, The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Obtain informed consent from the subject; 2. The clinical cure has passed the acute phase, and the condition deteriorates again after the condition is stable, and the patient cannot eat or the fever lasts for more than 1 week; 3. Enhanced CT showed "bubble sign" in intraperitoneal or peripancreatic lesions; 4. Exclude pulmonary infection, catheter infection, urinary tract infection and other non-pancreatic fever or deterioration; 5. Within 7 days before the operation, there was sufficient liver and kidney function, appropriate laboratory indicators (after treatment) : neutrophils >=1500/mm3, PLT>=50x10^9/L, and serum ALB>=28g/L. TBIL < 2mg/dL, ALT and AST < 5 times normal value, Bun and Cr < 1.5 times normal value, INR < 1.7 or PT extension < 4s.

Exclusion criteria

Exclusion criteria: 1.Congestive heart failure > New York heart association (NYHA) grade 2; 2. Uncontrolled high blood pressure; 3. A history of human immunodeficiency virus (HIV) infection; 4. Renal failure or insufficiency, requiring hemodialysis or peritoneal dialysis; 5. Severe active clinical infection (> level 2, nci-ctcae version 4.0); 6. Except for upper gastrointestinal bleeding or clear tendency of gastrointestinal bleeding within 4 weeks before surgery; 7. Subjects who are pregnant or breast-feeding; 8. Patients who had major surgery 4 weeks before the trial or who had not yet recovered from the side effects of such surgery; 9. Patients diagnosed with pancreatic neoplasms, such as cystadenoma (those who had been cured 3 years earlier could be included).

Design outcomes

Primary

MeasureTime frame
POPF;Postoperative biliary fistula;Postoperative intestinal fistula;postoperative complication;Incidence of infection;Average length of stay;

Countries

China

Contacts

Public ContactXinjian XU

The First Affiliated Hospital of Xinjiang Medical University

krron@163.com+86 18599025120

Outcome results

None listed

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