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

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527084
• Other study ID #: 8760PG11
• Status: Completed
• Phase: N/A
• First received: January 21, 2012
• Last updated: November 8, 2014
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• surgical intervention after percutaneous catheter drainage
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)

Locations

Country	Name	City	State
India	PGIMER	Chandigarh
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks	No
Primary	Reversal of existing organ failure		participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No