Acute PancreatitisFCMSAPNCT01321060
Fluid Collections Management in Severe Acute Pancreatitis
A study testing Aspiration, Catheter drainage and Conservative treatment in people with Acute Pancreatitis and Acute Pancreatic Fluid Collection, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pancreatitis, Acute Pancreatic Fluid Collection
- What is being tested?
- Aspiration, Catheter drainage and Conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2012
- 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
- Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
- CT density < 30Hu
- Within 7 days from the onset of the disease
- Available approach for percutaneous penetrate
Who cannot join
- Pregnant pancreatitis
- Receiving surgery or aspiration before;need of early surgery
- Infected fluid collection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of SICU, Research Institute of General Surgery Jinling Hospital,
Nanjing, Jiangsu, 210002
Weiqin Li, Dr, +86-025-80860066, kkb9832@gmail.com
Weiqin Li, Dr
About this study
Official title: Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.
- Being tested
- Aspiration, Catheter drainage, Conservative treatment
- Keywords
- severe acute pancreatitis, acute fluid collection, catheter drainage, repeated aspiration
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirationProcedure or surgery
Catheter drainageProcedure or surgery
Conservative treatmentDrug
Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Conservative treatment group with only drugs. Receives: Drug: Conservative treatment |
| Continuous catheter drainage | Experimental | Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied. Receives: Procedure: Catheter drainage |
| Repeated aspiration | Experimental | Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration. Receives: Procedure: Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
pancreatic infection
Measured: 28 days
mortality
Measured: 28 days
Secondary outcomes (7)
inflammation parameters
Measured: 28 days
intra abdominal pressure
Measured: 28 days
complications
intestinal fistula , major bleeding, etc.
Measured: 28 days
ICU duration
Measured: day one until discharge
hospital duration
Measured: day one until discharge
SIRS
Measured: 28 days
MODS
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China
- Responsible party
- Principal investigator, Weiqin Li, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321060
- Sponsor's protocol ID
- RIGS
- Acronym
- FCMSAP
- Status last verified
- Jan 2011
- First submitted
- 22 Mar 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01321060
- Acronym / sponsor ID
- FCMSAP / RIGS
- Keywords
- severe acute pancreatitis, acute fluid collection, catheter drainage, repeated aspiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Collaborators
- Jinling Hospital, China
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 23 Mar 2011 (estimated)
- 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.
Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Drug: Conservative treatmentConservative treatment group with only drugs. |
| Continuous catheter drainage | Experimental | Procedure: Catheter drainageOnce the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied. |
| Repeated aspiration | Experimental | Procedure: AspirationOnce the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
- CT density < 30Hu
- Within 7 days from the onset of the disease
- Available approach for percutaneous penetrate
Key exclusion criteria (3 listed)
- Pregnant pancreatitis
- Receiving surgery or aspiration before;need of early surgery
- Infected fluid collection
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 |
|---|---|---|
| Aspiration | Procedure or surgery | Repeated aspiration |
| Catheter drainage | Procedure or surgery | Continuous catheter drainage |
| Conservative treatmentIncluding antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation | Drug | Conservative treatment |
Primary outcome
pancreatic infection
Time frame: 28 days
mortality
Time frame: 28 days
7 secondary outcomes
inflammation parameters
Time frame: 28 days
intra abdominal pressure
Time frame: 28 days
complications
Time frame: 28 days
ICU duration
Time frame: day one until discharge
hospital duration
Time frame: day one until discharge
SIRS
Time frame: 28 days
MODS
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
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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 Aspiration, Catheter drainage and Conservative treatment in people with Acute Pancreatitis and Acute Pancreatic Fluid Collection, run by Nanjing 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 4 inclusion and 3 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 19 Jun 2012. 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 Weiqin Li, Dr (+86-025-80860066, kkb9832@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pancreatic infection (time frame: 28 days). The study lists 2 primary outcomes in all. 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 19 Jun 2012.