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

October 5, 2017 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized, Multicenter and Prospective Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The AFPCs is the most common complication in SAP and debate continues regarding the appropriate timing for drainage of sterile APFCs in SAP patients. Some researchers have reported that the massive amounts of inflammatory mediators in the peripancreatic fluid may aggravate the inflammatory reaction and contribute to organ failure (OF) when liberated into the bloodstream by peritoneal absorption. Additionally, bacterial colonization of APFCs may lead to peritoneal abscess formation and sepsis. In a recent study, Wang et al. revealed that early-stage PCD effectively attenuated the peritoneal pressure and decreased the incidence of infection and OF. Finally, APFCs and secondary infection are considered major causes of alimentary tract hemorrhage. Based on these factors, prompt drainage of APFCs seems reasonable for patients in early SAP. In addition, unlike the original 1992 Atlanta classification guidelines (1992-AC), the revision of the 1992-AC by international consensus in 2012 (2012-RAC) highlighted the significance of persistent OF in the classification of SAP. To be exact, those patients diagnosed with SAP according to the 1992-AC without OF or with transient OF were reclassified as having mild AP (MAP) or moderate severity AP (MSAP) by the 2012-RAC. Therefore, many studies have reported changes in the treatment of SAP in the early stages since the 2012-RAC were published. We have retrospectively analyzed 361 patients with AP and found that the early-stage PCD of sterile APFCs in SAP-2012RAC patients can significantly reduce the mortality rate. However, on the contrary, the mainstream viewpoint holds that drainage is not necessary in the absence of infection of the peripancreatic fluid as the fluid can be absorbed completely and sterile PCD may increase the risk of iatrogenic infection. However, these mainstream views aimed at 1992-AC's SAP patients, which actually contain 2012-RAC's SAP and MSAP. Therefore, we hypothesized that the introduction of new AP severity classification methods may alter the indications for early aseptic drainage of AFPCs.

Does early PCD of sterile APFCs benefits patients or increases the secondary infection rate? In view of these problems, we plan to design a randomized controlled trial 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. The aim of this prospective study is to investigate whether early PCD of sterile AFPCs can be used to SAP patients with AFPCs at early stage.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University
        • Contact:
          • Yun Zhang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of 18 years to 70 years; and
  2. Pain characteristic of pancreatitis; and
  3. Elevated serum lipase or amylase (≥3-fold upper normal range); and
  4. Persistent organ failure >48 hours; and
  5. Organ dysfunction occurred within 7 days after onset of pain; and
  6. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Puncture and Drainage
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
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
No Intervention: Conservative therapy
The enrolled SAP patients are administered conservative therapy and without puncture and prolonged drainage.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary infection of peripancreatic collections
Time Frame: From date of admisstion until the secondary infection of peripancreatic collections occurred, assessed up to 100 days
Compare the secondary infection rates of peripancreatic collections in patients who are administered drainage and conservative therapy: Assess the total numbers of cases of secondary infection of peripancreatic collections in each group (Treatment and control)
From date of admisstion until the secondary infection of peripancreatic collections occurred, assessed up to 100 days
New set of organ failure
Time Frame: From date of admisstion until new set of organ failure occurred, assessed up to 100 days
Compare the new set of organ failure rates in patients who are administered drainage and conservative therapy: Assess the total numbers of cases of new set of organ failure in each group (Treatment and control)
From date of admisstion until new set of organ failure occurred, assessed up to 100 days
Length of hospital/ICU stay
Time Frame: From date of admisstion until the patient is transfered to normal ward or discharge, whichever came first, assessed up to 1 year.
Compare the length of hospital/ICU stay in patients who are administered drainage and conservative therapy
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
Time Frame: From date of admisstion until the patient receives aggressive procedures, assessed up to 100 days
Compare the aggressive procedures rates in patients who are administered drainage and conservative therapy.
From date of admisstion until the patient receives aggressive procedures, assessed up to 100 days
Abdominal hemorrhage
Time Frame: From date of admisstion until the abdominal hemorrhage occurred, assessed up to 100 days
Compare the abdominal hemorrhage rates in patients who are administered drainage and conservative therapy.
From date of admisstion until the abdominal hemorrhage occurred, assessed up to 100 days
Digestive tract fistula
Time Frame: From date of admisstion until the Digestive tract fistula occurred, assessed up to 100 days
Compare the digestive tract fistula rates in patients who are administered drainage and conservative therapy.
From date of admisstion until the Digestive tract fistula occurred, assessed up to 100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 6, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAHZhejiangU-EPCDSAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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