Clinical trial NCT01527084: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2012-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
2. 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.

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:

1. 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)
2. Sterile pancreatic necrosis
3. An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
4. Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
5. Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy

Primary outcomes:
measure: Mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
measure: Reversal of existing organ failure
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
measure: New onset multiorgan failure or sepsis and systemic complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
measure: Locoregional complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Secondary outcomes:
measure: Proportion of patients in which surgery would be avoided in Group B
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
measure: Pancreatic insufficiency (New onset Diabetes and steatorrhea)
timeFrame: participants will be followed for the duration of hospital discharge to end of our study period, an expected average duration of 1 year
measure: Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: PGIMER
name: Rajesh Gupta, MBBS,MS, MCh
role: PRINCIPAL_INVESTIGATOR
References: