PancreatitisNCT02002793
Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
A study testing Early stage abdominal drainage and Late stage abdominal drainage in people with Pancreatitis, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis
- What is being tested?
- Early stage abdominal drainage and Late stage abdominal drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2013to Aug 2017
- 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
- 1.Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta criteria revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection
- -
Who cannot join
- 1.Pregnancy 2.Heart function: NYHA >II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy < 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure>25cmH2O 9.At least one organ'S newly emerged dysfunction
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin
Shanghai, Shanghai Municipality, 20000
erzhen Chen, PhD, 66370045 ext. 665520, chenerzhen@hotmail.com
About this study
This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion.
Read the detailed description
Pancreatitis associated ascetic fluids(PAAF) gather with the beginning of SAP and induced IAP(intra-abdominal pressure) increasement.With an excess of 12mmHg ,IAP presents as IAH(intra-abdominal hypertension) and when a ≥20mmHg IAP accompanied with at least one organ's dysfunction it is ACS(abdominal compartment syndrome).Previous recommended theraphy of ACS is laparotomy.However,with inherited advantages such as ease-to-operate and minimal invassiveness, early stage mini-invasive abdominal drainage therapies , for example, percutaneous catheter drainage(PCD) instructed by ultrasound or CT ,have shown a promised future in recent years. It is reported that patients acquired PCD decreased 81% in operation rate compared to those who did not and had lower mortality rate. Whereas, the operation flow of early stage mini-invasive abdominal drainage remains controversial, and whose validity calls for evidence from large-scale clinical trials.
- Conditions
- Pancreatitis
- Being tested
- Early stage abdominal drainage, Late stage abdominal drainage
- Keywords
- pancreatitis, early stage, mini-invasive abdominal drainage
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early stage abdominal drainageOther
Ultrasound/CT/GUS guided abdominocentesis and drainage with single-chamber deep venous catheters shoule be implemented and the catheter should be removed when abdominal drainage flow≤100ml in two successive days;
Late stage abdominal drainageOther
Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT scan:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis;
| Study group | Role | What they receive |
|---|---|---|
| Early stage abdominal drainage | Other | SAP patients who matches one of the following criteria:1．Intravesical pressure≥20cmH2O or 2.CT images:acute peripancreatic liquid collection should have early stage abdominal drainage immediately; Receives: Other: Early stage abdominal drainage |
| Late stage abdominal drainage | Other | Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT images:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis; Receives: Other: Late stage abdominal drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of ACS in 28 days since outbreaks
Time of first attacks of these situations that have to be surgically interfered in 28 days since onsets: ACS or pancreatic necrosis, abdominal hemorrhage, pancreatic abscess or pancreatic pseudocyst which brings symptoms or complications or increase in size;rates of organs' dysfunction, abdominal infection and reuse of drainage;
Measured: 28 days
Secondary outcomes (1)
Rates of surgical interfere, MODS or death in 6 months since outbreaks
Rates of mortality or organs' dysfunction; rates of complications, including: pancreatic leakage, pancreatic pseudocysts in need of surgical interfere, pancreatic abscess, bile duct stricture and pancreatic insufficiency; times of surgery, hospital stay, time in ICU and hospitalization expense;
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, Erzhen Chen, Ruijin Hospital
- Investigators
- erzhen Chen, Professor, Study director, Emergency intensive care unit of Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002793
- Sponsor's protocol ID
- SAP bundle-abdominal drainage
- Status last verified
- Dec 2013
- First submitted
- 11 Nov 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Stage Mini-invasive Abdominal Drainage on Complications and Prognosis of SAP
- ClinicalTrials.gov ID
- NCT02002793
- Acronym / sponsor ID
- SAP bundle-abdominal drainage
- Conditions
- Pancreatitis
- Keywords
- pancreatitis, early stage, mini-invasive abdominal drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- Aug 2013
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 6 Dec 2013 (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.
This study aims to standardized the process of mini-invasive abdominal draniage of SAP in early stage.To determine the indications and occasion.
Detailed description
Pancreatitis associated ascetic fluids(PAAF) gather with the beginning of SAP and induced IAP(intra-abdominal pressure) increasement.With an excess of 12mmHg ,IAP presents as IAH(intra-abdominal hypertension) and when a ≥20mmHg IAP accompanied with at least one organ's dysfunction it is ACS(abdominal compartment syndrome).Previous recommended theraphy of ACS is laparotomy.However,with inherited advantages such as ease-to-operate and minimal invassiveness, early stage mini-invasive abdominal drainage therapies , for example, percutaneous catheter drainage(PCD) instructed by ultrasound or CT ,have shown a promised future in recent years. It is reported that patients acquired PCD decreased 81% in operation rate compared to those who did not and had lower mortality rate. Whereas, the operation flow of early stage mini-invasive abdominal drainage remains controversial, and whose validity calls for evidence from large-scale clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stage abdominal drainage | Other | Other: Early stage abdominal drainageSAP patients who matches one of the following criteria:1．Intravesical pressure≥20cmH2O or 2.CT images:acute peripancreatic liquid collection should have early stage abdominal drainage immediately; |
| Late stage abdominal drainage | Other | Other: Late stage abdominal drainageDespite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT images:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis; |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Diagnosis of pancreatitis 2.Onset of abdominal pain within 72h 3.Moderate severe or severe AP according to Atlanta criteria revisited in 2012 4.Intravesical pressure≥20cmH2O 4.CT images:acute peripancreatic liquid collection
- -
Key exclusion criteria (2 listed)
- 1.Pregnancy 2.Heart function: NYHA >II 3.Pacemaker implantation 4.COPD 5.CKD 6.Pre-existing disease with life expectancy < 3 months 7.CT images:No acute peripancreatic liquid collection 8.Intravesical pressure>25cmH2O 9.At least one organ'S newly emerged dysfunction
- -
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 |
|---|---|---|
| Early stage abdominal drainageUltrasound/CT/GUS guided abdominocentesis and drainage with single-chamber deep venous catheters shoule be implemented and the catheter should be removed when abdominal drainage flow≤100ml in two successive days; | Other | Early stage abdominal drainage |
| Late stage abdominal drainageDespite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT scan:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis; | Other | Late stage abdominal drainage |
Primary outcome
Rates of ACS in 28 days since outbreaks
Time frame: 28 days
Time of first attacks of these situations that have to be surgically interfered in 28 days since onsets: ACS or pancreatic necrosis, abdominal hemorrhage, pancreatic abscess or pancreatic pseudocyst which brings symptoms or complications or increase in size;rates of organs' dysfunction, abdominal infection and reuse of drainage;
1 secondary outcome
Rates of surgical interfere, MODS or death in 6 months since outbreaks
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
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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.
erzhen Chen, Professor study director
Emergency intensive care unit of Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early stage abdominal drainage and Late stage abdominal drainage in people with Pancreatitis, run by Ruijin Hospital 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 2 inclusion and 2 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 6 Dec 2013. 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 erzhen Chen, PhD (64370045 ext. 665520, chenerzhen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of ACS in 28 days since outbreaks (time frame: 28 days). 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 6 Dec 2013.