Use of Streptokinase for Enhancement of Percutaneous Drainage of Pancreatic Necrosis

NCT01977118 | Completed Phase 2 DMC

• 1 other identifier: NK/1180/M.CH
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Streptokinase; Percutaneous catheter drainage; Pancreatic necrosis; peripancreatic necrosis

Outcome Measures

Primary Outcomes (2)

• Sepsis reversal

  From date of randomization until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month

• Mortality

  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

  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

  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

  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

  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

  From date of first pigtail insertion until the date of necrosectomy, discharge or death from any cause, whichever came first, assessed upto 1 month

Study Arms (2)

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

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

Other: Saline irrigation

Interventions

streptokinase 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 B [streptokinase]

Saline irrigation 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

Group A [placebo]

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with severe acute pancreatitis managed by percutaneous catheter drainage

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Acute Necrotizing

Interventions

Streptokinase

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Rajesh Gupta, M.Ch.

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor, Division of Surgical Gastroenterology, Department of General Surgery

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 6, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

IN (1)