Back to resultsTiming of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis
Primary Purpose
Acute Pancreatitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
surgical intervention after percutaneous catheter drainage
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- PGIMER
- Postgraduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
undergo surgery between days 10 - 15 after PCD
continued with PCD beyond 15 days and indications for surgery in them will be, Persistent sepsis or symptoms Worsening of clinical condition Failure to thrive Complications of SAP or PCD
Outcomes
Primary Outcome Measures
Mortality
Reversal of existing organ failure
New onset multiorgan failure or sepsis and systemic complications
Locoregional complications
Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention
Secondary Outcome Measures
Proportion of patients in which surgery would be avoided in Group B
Pancreatic insufficiency (New onset Diabetes and steatorrhea)
Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications
Full Information
NCT ID
NCT01527084
First Posted
January 21, 2012
Last Updated
November 8, 2014
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01527084
Brief Title
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis
Official Title
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
undergo surgery between days 10 - 15 after PCD
Arm Title
Group B
Arm Type
Other
Arm Description
continued with PCD beyond 15 days and indications for surgery in them will be,
Persistent sepsis or symptoms
Worsening of clinical condition
Failure to thrive
Complications of SAP or PCD
Intervention Type
Procedure
Intervention Name(s)
surgical intervention after percutaneous catheter drainage
Intervention Description
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)
Primary Outcome Measure Information:
Title
Mortality
Time Frame
participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Title
Reversal of existing organ failure
Time Frame
participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Title
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
Title
Locoregional complications
Description
Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention
Time Frame
participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Gupta, MBBS,MS, MCh
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Learn more about this trial
Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis
We'll reach out to this number within 24 hrs