Severe Acute PancreatitisEPCDSAPNCT03185806
A Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis
A study testing Puncture and drainage in people with Severe Acute Pancreatitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Acute Pancreatitis
- What is being tested?
- Puncture and drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 6 Oct 2017to 6 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang
Yun Zhang, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Severe Acute Pancreatitis
- Being tested
- Puncture and drainage
- Keywords
- severe acute pancreatitis, sterile acute peripancreatic fluid collections, percutaneous catheter drainage
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puncture and drainageDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Puncture and drainage |
| Conservative therapy | No intervention | The enrolled SAP patients are administered conservative therapy and without puncture and prolonged drainage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: From date of admisstion until the secondary infection of peripancreatic collections occurred, assessed up to 100 days
New set of organ failure
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)
Measured: From date of admisstion until new set of organ failure occurred, assessed up to 100 days
Length of hospital/ICU stay
Compare the length of hospital/ICU stay in patients who are administered drainage and conservative therapy
Measured: 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
Compare the aggressive procedures rates in patients who are administered drainage and conservative therapy.
Measured: From date of admisstion until the patient receives aggressive procedures, assessed up to 100 days
Abdominal hemorrhage
Compare the abdominal hemorrhage rates in patients who are administered drainage and conservative therapy.
Measured: From date of admisstion until the abdominal hemorrhage occurred, assessed up to 100 days
Digestive tract fistula
Compare the digestive tract fistula rates in patients who are administered drainage and conservative therapy.
Measured: From date of admisstion until the Digestive tract fistula occurred, assessed up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start6 Oct 2017 (estimated)
- Primary completion6 Oct 2020 (estimated)
- Study completion6 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185806
- Sponsor's protocol ID
- SAHZhejiangU-EPCDSAP
- Acronym
- EPCDSAP
- Status last verified
- May 2017
- First submitted
- 30 May 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter and Prospective Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03185806
- Acronym / sponsor ID
- EPCDSAP / SAHZhejiangU-EPCDSAP
- Conditions
- Severe Acute Pancreatitis
- Keywords
- severe acute pancreatitis, sterile acute peripancreatic fluid collections, percutaneous catheter drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Oct 2017 (estimated)
- Primary completion
- 6 Oct 2020 (estimated)
- Study completion
- 6 Oct 2020 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Puncture and Drainage | Experimental | Device: Puncture and drainageThe enrolled SAP patients are administered puncture and drainage use 8-F or 10-F pigtail tube under guidance of B ultrasound or CT scan. |
| Conservative therapy | No intervention | –The enrolled SAP patients are administered conservative therapy and without puncture and prolonged drainage. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Puncture and drainageThe enrolled SAP patients are punctured under guidance of B ultrasound or CT scan, and prolonged drained by 8-F or 10-F pigtail tube | Device | Puncture and Drainage |
Primary outcome
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)
6 secondary outcomes
Secondary infection of peripancreatic collections
Time frame: 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
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.
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
Abdominal hemorrhage
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puncture and drainage in people with Severe Acute Pancreatitis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingbo Liang, MD,PhD (86-571-87315006, liangtingbo@zj.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.