Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis

NCT ID: NCT01977118

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-12-31

Brief 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. 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.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group B [streptokinase]

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

Group Type: EXPERIMENTAL

streptokinase

Intervention Type: DRUG

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.

Group A [placebo]

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

Group Type: PLACEBO_COMPARATOR

Saline irrigation

Intervention Type: OTHER

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

Interventions

streptokinase

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.

Intervention Type: DRUG

Saline irrigation

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with severe acute pancreatitis managed by percutaneous catheter drainage

Exclusion Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Gupta

Additional Professor, Division of Surgical Gastroenterology, Department of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh Gupta, M.Ch.

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Countries

India

Other Identifiers

NK/1180/M.CH

Identifier Type: -

Identifier Source: org_study_id