Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Procedure: surgical intervention after percutaneous catheter drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>undergo surgery between days 10 - 15 after PCD | Procedure: surgical intervention after percutaneous catheter drainage<br>* 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)<br>|
| Other: Group B<br>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 | Procedure: surgical intervention after percutaneous catheter drainage<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks | 
| Reversal of existing organ failure |  | 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 |  | 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 | participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients in which surgery would be avoided in Group B |  | participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks | 
| Pancreatic insufficiency (New onset Diabetes and steatorrhea) |  | 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 |  | participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks |