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

NCT01527084 | Completed

• 1 other identifier: 8760PG11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
2. 2.To see the change in morbidity and mortality after changing the interval of surgery after PCD

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group A

OTHER

undergo surgery between days 10 - 15 after PCD

Procedure: surgical intervention after percutaneous catheter drainage

Group B

OTHER

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

Procedure: surgical intervention after percutaneous catheter drainage

Interventions

surgical intervention after percutaneous catheter drainage PROCEDURE

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)

Group A; Group B

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Rajesh Gupta, MBBS,MS, MCh

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2012
• First Posted: February 6, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

IN (2)