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

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Procedure: surgical intervention after percutaneous catheter drainage

• Registration Number: NCT01527084
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-01-21
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-08
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	surgical intervention after percutaneous catheter drainage	continued with PCD beyond 15 days and indications for surgery in them will be, 1. Persistent sepsis or symptoms 2. Worsening of clinical condition 3. Failure to thrive 4. Complications of SAP or PCD
Group A	surgical intervention after percutaneous catheter drainage	undergo surgery between days 10 - 15 after PCD

Primary Outcome Measures

Name	Time	Method
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	participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks	Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (2)

PGIMER; 🇮🇳 Chandigarh, India

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India