Acute PancreatitisPhase 2/3NCT01977118
Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis
A Phase 2/3 study testing streptokinase and Saline irrigation in people with Acute Pancreatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collection. Percutaneous catheter drainage successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- streptokinase and Saline irrigation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- May 2013to Dec 2014
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with severe acute pancreatitis managed by percutaneous catheter drainage
Who cannot join
- An acute intra abdominal event (perforation of hollow viscus, bleeding, or abdominal compartment syndrome) before or 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
- Patients who are allergic to streptokinase.
- Patients with deranged coagulation profile.
- Patients with recent history of cerebrovascular accident [< 2 months], intracranial or intraspinal surgery, uncontrolled hypertension, intracranial neoplasm.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: Phase 2/3 Study of Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collection.
Percutaneous catheter drainage successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage which demands surgical debridement.
Read more
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen.
In the present study investigators plan to instill streptokinase locally in to the collections of patients with severe acute pancreatitis via pigtail catheter inorder to liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby delays or obviates the need for necrosectomy.
Read the detailed description
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collections. Sterile necrosis can generally be managed conservatively and the mortality rate is relatively low (12 per cent). Approximately 30 (range 14-62) per cent of patients with necrotizing pancreatitis, however, develop secondary infections of peripancreatic fluid collection which is associated with sepsis and organ failure and is an indication for intervention1.
Until recently, the first-choice intervention in patients with infected necrotizing pancreatitis or sterile necrosis with clinical deterioration (multiple organ failure) has been open surgical necrosectomy. This approach is associated with considerable morbidity (34-95 per cent) and mortality (11-39 per cent). In 1998, Freeny and colleagues10 first described a consecutive series of patients with infected pancreatic necrosis who were treated primarily with imaging-guided percutaneous catheter drainage (PCD), as an alternative to primary surgical necrosectomy. The rationale for PCD was to drain the infected fluid under tension and gain time to improve organ function of these critically ill patients and thereby delay or avoid surgical necrosectomy. In their retrospective cohort study, PCD was successful in postponing surgical intervention for a median of 4 weeks and even obviated the need for surgical necrosectomy in almost half of the patients. In addition, PCD seems technically feasible in the vast majority of patients with necrotizing pancreatitis.
In clinical experience, investigators have found that PCD successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of PCD which demands surgical debridement.
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen. It is primarily used in clinical practice intravenously as an effective thrombolytic agent in cases of myocardial infarction and pulmonary thromboembolism.
The earliest reports on intracavitatory use of Streptokinase and other fibrinolytics were for empyemas. Later because of beneficial results, their intracavitatory use was extended to other conditions like liver, retroperitoneal and peritoneal abscesses.
In a phase II study, intracavitatory urokinase has shown to facilitate percutaneous drainage significantly reduce hospital stay and costs of percutaneous drainage of intra abdominal, retroperitoneal abscesses.
In the present study investigators plan to instill streptokinase locally in to the collections of patients with severe acute pancreatitis via pigtail catheter inorder to liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby delays or obviates the need for necrosectomy.
- Conditions
- Acute Pancreatitis
- Being tested
- streptokinase, Saline irrigation
- Keywords
- Streptokinase, Percutaneous catheter drainage, Pancreatic necrosis, peripancreatic necrosis
- Medical subject headings
- Pancreatitis, Pancreatitis, Acute Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
streptokinaseDrug
50000U of injection streptokinase dissolved in 100ml of diluent instilled in to the pancreatic and/or peripancreatic collections via percutaneous catheters and clamped for 2 hours in Streptokinase group. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days.
Saline irrigationOther
100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days
| Study group | Role | What they receive |
|---|---|---|
| Group B [streptokinase] | Experimental | 50000U of injection streptokinase dissolved in 100ml of normal saline instilled in to the pancreatic and/or peripancreatic collections via the percutaneous catheters and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of normal saline. This procedure will be done thrice daily for five days Receives: Drug: streptokinase |
| Group A [placebo] | Placebo comparator | 100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days Receives: Other: Saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis reversal
Measured: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Mortality
Measured: From the date of randomization until last follow up after discharge, assessed up to 1 month
Secondary outcomes (6)
Length of intensive care unit (ICU) and hospital stay
Measured: From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month
Proportion of patients requiring surgical necrosectomy
Measured: From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month
Number and size of catheters required
Measured: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Number of interventions required
Measured: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Catheter-related complications
Measured: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Streptokinase related complications
Measured: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 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, M.Ch., Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977118
- Sponsor's protocol ID
- NK/1180/M.CH
- Status last verified
- Jul 2016
- First submitted
- 23 Oct 2013
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2/3 Study of Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis
- ClinicalTrials.gov ID
- NCT01977118
- Acronym / sponsor ID
- NK/1180/M.CH
- Conditions
- Acute Pancreatitis
- Keywords
- Streptokinase, Percutaneous catheter drainage, Pancreatic necrosis, peripancreatic necrosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Nov 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.
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collection.
Percutaneous catheter drainage successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of percutaneous catheter drainage which demands surgical debridement.
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen.
In the present study investigators plan to instill streptokinase locally in to the collections of patients with severe acute pancreatitis via pigtail catheter inorder to liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby delays or obviates the need for necrosectomy.
Detailed description
Around 20 per cent of patients with acute pancreatitis develop pancreatic or peripancreatic necrosis with or without peripancreatic collections. Sterile necrosis can generally be managed conservatively and the mortality rate is relatively low (12 per cent). Approximately 30 (range 14-62) per cent of patients with necrotizing pancreatitis, however, develop secondary infections of peripancreatic fluid collection which is associated with sepsis and organ failure and is an indication for intervention1.
Until recently, the first-choice intervention in patients with infected necrotizing pancreatitis or sterile necrosis with clinical deterioration (multiple organ failure) has been open surgical necrosectomy. This approach is associated with considerable morbidity (34-95 per cent) and mortality (11-39 per cent). In 1998, Freeny and colleagues10 first described a consecutive series of patients with infected pancreatic necrosis who were treated primarily with imaging-guided percutaneous catheter drainage (PCD), as an alternative to primary surgical necrosectomy. The rationale for PCD was to drain the infected fluid under tension and gain time to improve organ function of these critically ill patients and thereby delay or avoid surgical necrosectomy. In their retrospective cohort study, PCD was successful in postponing surgical intervention for a median of 4 weeks and even obviated the need for surgical necrosectomy in almost half of the patients. In addition, PCD seems technically feasible in the vast majority of patients with necrotizing pancreatitis.
In clinical experience, investigators have found that PCD successfully drains the liquefied component of pancreatic necrosis while the solid component still remains undrained. This infected solid component of pancreatic necrosis is probably responsible for failure of PCD which demands surgical debridement.
Streptokinase is a protein secreted by several species of streptococci which can bind and activate human plasminogen. It is primarily used in clinical practice intravenously as an effective thrombolytic agent in cases of myocardial infarction and pulmonary thromboembolism.
The earliest reports on intracavitatory use of Streptokinase and other fibrinolytics were for empyemas. Later because of beneficial results, their intracavitatory use was extended to other conditions like liver, retroperitoneal and peritoneal abscesses.
In a phase II study, intracavitatory urokinase has shown to facilitate percutaneous drainage significantly reduce hospital stay and costs of percutaneous drainage of intra abdominal, retroperitoneal abscesses.
In the present study investigators plan to instill streptokinase locally in to the collections of patients with severe acute pancreatitis via pigtail catheter inorder to liquefy the solid necrotic component and analyze whether it hastens the drainage and thereby delays or obviates the need for necrosectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B [streptokinase] | Experimental | Drug: streptokinase50000U of injection streptokinase dissolved in 100ml of normal saline instilled in to the pancreatic and/or peripancreatic collections via the percutaneous catheters and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of normal saline. This procedure will be done thrice daily for five days |
| Group A [placebo] | Placebo comparator | Other: Saline irrigation100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe acute pancreatitis managed by percutaneous catheter drainage
Key exclusion criteria (6 listed)
- An acute intra abdominal event (perforation of hollow viscus, bleeding, or abdominal compartment syndrome) before or 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
- Patients who are allergic to streptokinase.
- Patients with deranged coagulation profile.
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 |
|---|---|---|
| streptokinase50000U of injection streptokinase dissolved in 100ml of diluent instilled in to the pancreatic and/or peripancreatic collections via percutaneous catheters and clamped for 2 hours in Streptokinase group. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days. | Drug | Group B [streptokinase] |
| Saline irrigation100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days | Other | Group A [placebo] |
Primary outcome
Sepsis reversal
Time frame: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Mortality
Time frame: From the date of randomization until last follow up after discharge, assessed up to 1 month
6 secondary outcomes
Length of intensive care unit (ICU) and hospital stay
Time frame: From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month
Proportion of patients requiring surgical necrosectomy
Time frame: From date of randomization until the date of discharge or death from any cause, whichever came first, assessed upto 1 month
Number and size of catheters required
Time frame: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Number of interventions required
Time frame: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Catheter-related complications
Time frame: From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
Streptokinase related complications
Time frame: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month
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 7 Jul 2016.
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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, M.Ch. principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing streptokinase and Saline irrigation in people with Acute Pancreatitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site 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 6 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 7 Jul 2016. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sepsis reversal (time frame: From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month). 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 7 Jul 2016.