A Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis

NCT03185806 | Unknown DMC

• 1 other identifier: SAHZhejiangU-EPCDSAP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The acute peripancreatic fluid collections (AFPCs) is the most common complication in severe acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid collections is questioned as a result of the major cause of secondary infection. The aim of the present randomized controlled trial is to compare the outcomes in terms of mortality, secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative therapy.

Conditions

Severe Acute Pancreatitis

Keywords

severe acute pancreatitis; sterile acute peripancreatic fluid collections; percutaneous catheter drainage

Outcome Measures

Primary Outcomes (1)

• Mortality

  Determine and compare the death rates in patients who are administered drainage and conservative therapy: Assess the total number of cases of death in each group (Treatment and control)

  From date of admisstion until the date of in-hospital death or death within two weeks after discharging, whichever came first, assessed up to 1 year.

Secondary Outcomes (6)

• Secondary infection of peripancreatic collections

  From date of admisstion until the secondary infection of peripancreatic collections occurred, assessed up to 100 days

• New set of organ failure

  From date of admisstion until new set of organ failure occurred, assessed up to 100 days

• Length of hospital/ICU stay

  From date of admisstion until the patient is transfered to normal ward or discharge, whichever came first, assessed up to 1 year.

• Aggressive procedures: open necrosectomy and minimally invasive retroperitoneal necrosectomy

  From date of admisstion until the patient receives aggressive procedures, assessed up to 100 days

• Abdominal hemorrhage

  From date of admisstion until the abdominal hemorrhage occurred, assessed up to 100 days

Study Arms (2)

Puncture and Drainage

EXPERIMENTAL

The enrolled SAP patients are administered puncture and drainage use 8-F or 10-F pigtail tube under guidance of B ultrasound or CT scan.

Device: Puncture and drainage

Conservative therapy

NO INTERVENTION

The enrolled SAP patients are administered conservative therapy and without puncture and prolonged drainage.

Interventions

Puncture and drainage DEVICE

The enrolled SAP patients are punctured under guidance of B ultrasound or CT scan, and prolonged drained by 8-F or 10-F pigtail tube

Puncture and Drainage

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years to 70 years; and
• Pain characteristic of pancreatitis; and
• Elevated serum lipase or amylase (≥3-fold upper normal range); and
• Persistent organ failure \>48 hours; and
• Organ dysfunction occurred within 7 days after onset of pain; and
• Presentation with a width of ≥2cm of APFCs in the peripheral tissues of the pancreas, the cyst of lesser omentum , or the paracolic sulci on CT image.

You may not qualify if:

• History diseases of chronic organ dysfunction; or
• Traumatic pancreatitis; or
• Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis; or
• Severe coagulopathy (INR\>2); or
• Severe thrombocytopenia (PLT≤50×109/L); or
• No suitable route for puncturing; or
• Pregnancy; or
• Absent of informed consent from patient or representative.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Drainage; Therapeutics; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Tingbo Liang, MD,PhD

CONTACT

86-571-87315006; liangtingbo@zj.edu.cn

Yun Zhang, MD

CONTACT

86-571-87315006; bigzyun@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 14, 2017
• Study Start: October 6, 2017
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: October 9, 2017

Record last verified: 2017-05

Locations

CN (1)