Acute PancreatitisNCT01527084
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis
A study testing surgical intervention after percutaneous catheter drainage in people with Acute Pancreatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial summary
1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN). 2. To see the change in morbidity and mortality after changing the interval of surgery after PCD Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- surgical intervention after percutaneous catheter drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIndia
- Study dates
- Jul 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with diagnosis of IPN (UK GUIDELINES) managed with percutaneous catheter drainage (PCD) for 10 to 15 days and not showing significant improvement on PCD will be included
Who cannot join
- Patient showing significant improvement on PCD within 10 days of its insertion.(Significant improvement on PCD is defined as resolution of fever, acceptance of enteral nutrition, decrease in total leukocyte count, reversal of organ system failure)
- Sterile pancreatic necrosis
- An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
- Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
- Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
Trial locations and contacts
2 sites in 1 country.
India2 sites
PGIMER
Chandigarh, Chandigarh, 160012
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
About this study
Official title: Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud
- To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
- To see the change in morbidity and mortality after changing the interval of surgery after PCD
Read the detailed description
In present study we plan to determine the appropriate timing of surgical intervention after PCD in step up approach of Infected pancreatic necrosis (IPN).
The investigators also intend to evaluate the role of PCD in obviating the surgical intervention in the management of IPN and evaluate the risks \& benefits of extended treatment policy of PCD in step up approach of IPN in comparison to early surgery after PCD.
- Conditions
- Acute Pancreatitis
- Being tested
- surgical intervention after 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.
surgical intervention after percutaneous catheter drainageProcedure or surgery
Patients who are not improving by day 10 after PCD insertion will be included in the present study and are randomized to group A (early surgery i.e. between 10-15days after PCD insertion ) or group B (Extended treatment with PCD with saline irrigation for more than 15days after PCD insertion)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | undergo surgery between days 10 - 15 after PCD Receives: Procedure: surgical intervention after percutaneous catheter drainage |
| Group B | Other | continued with PCD beyond 15 days and indications for surgery in them will be,
1. Persistent sepsis or symptoms
2. Worsening of clinical condition
3. Failure to thrive
4. Complications of SAP or PCD Receives: Procedure: surgical intervention after percutaneous catheter drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Reversal of existing organ failure
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
New onset multiorgan failure or sepsis and systemic complications
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Locoregional complications
Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Secondary outcomes (3)
Proportion of patients in which surgery would be avoided in Group B
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Pancreatic insufficiency (New onset Diabetes and steatorrhea)
Measured: participants will be followed for the duration of hospital discharge to end of our study period, an expected average duration of 1 year
Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications
Measured: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh Gupta, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Rajesh Gupta, MBBS,MS, MCh, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527084
- Sponsor's protocol ID
- 8760PG11
- Status last verified
- Nov 2014
- First submitted
- 21 Jan 2012
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud
- ClinicalTrials.gov ID
- NCT01527084
- Acronym / sponsor ID
- 8760PG11
- Conditions
- Acute Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Feb 2012 (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.
- To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
- To see the change in morbidity and mortality after changing the interval of surgery after PCD
Detailed description
In present study we plan to determine the appropriate timing of surgical intervention after PCD in step up approach of Infected pancreatic necrosis (IPN).
The investigators also intend to evaluate the role of PCD in obviating the surgical intervention in the management of IPN and evaluate the risks \& benefits of extended treatment policy of PCD in step up approach of IPN in comparison to early surgery after PCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Procedure: surgical intervention after percutaneous catheter drainageundergo surgery between days 10 - 15 after PCD |
| Group B | Other | Procedure: surgical intervention after percutaneous catheter drainagecontinued with PCD beyond 15 days and indications for surgery in them will be, 1. Persistent sepsis or symptoms 2. Worsening of clinical condition 3. Failure to thrive 4. Complications of SAP or PCD |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with diagnosis of IPN (UK GUIDELINES) managed with percutaneous catheter drainage (PCD) for 10 to 15 days and not showing significant improvement on PCD will be included
Key exclusion criteria (5 listed)
- Patient showing significant improvement on PCD within 10 days of its insertion.(Significant improvement on PCD is defined as resolution of fever, acceptance of enteral nutrition, decrease in total leukocyte count, reversal of organ system failure)
- Sterile pancreatic necrosis
- An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
- Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
- Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
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 |
|---|---|---|
| surgical intervention after percutaneous catheter drainagePatients who are not improving by day 10 after PCD insertion will be included in the present study and are randomized to group A (early surgery i.e. between 10-15days after PCD insertion ) or group B (Extended treatment with PCD with saline irrigation for more than 15days after PCD insertion) | Procedure or surgery | Group A, Group B |
Primary outcome
Mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Reversal of existing organ failure
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
New onset multiorgan failure or sepsis and systemic complications
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Locoregional complications
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention
3 secondary outcomes
Proportion of patients in which surgery would be avoided in Group B
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Pancreatic insufficiency (New onset Diabetes and steatorrhea)
Time frame: participants will be followed for the duration of hospital discharge to end of our study period, an expected average duration of 1 year
Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications
Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Rajesh Gupta, MBBS,MS, MCh principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical intervention after percutaneous catheter drainage in people with Acute Pancreatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks). The study lists 4 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 11 Nov 2014.