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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rajesh Gupta, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01527084
First received: January 21, 2012
Last updated: February 3, 2012
Last verified: February 2012
  Purpose
  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

Condition Intervention
Acute Pancreatitis
Procedure: surgical intervention after percutaneous catheter drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
  • Reversal of existing organ failure [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
  • New onset multiorgan failure or sepsis and systemic complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
  • Locoregional complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
    Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention


Secondary Outcome Measures:
  • Proportion of patients in which surgery would be avoided in Group B [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]
  • Pancreatic insufficiency (New onset Diabetes and steatorrhea) [ Time Frame: participants will be followed for the duration of hospital discharge to end of our study period, an expected average duration of 1 year ] [ Designated as safety issue: No ]
  • Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
undergo surgery between days 10 - 15 after PCD
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)
Group B

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
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)

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

Ages Eligible for Study:   14 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527084

Contacts
Contact: Rajesh Gupta, MBBS,MS, MCh +919216512636 rajsarakshi@yahoo.co.in
Contact: Sunil Shenvi, MBBS,MS, +919855636559 reach_sunny05@yahoo.co.in

Locations
India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, India, 160012
Contact: Rajesh Gupta, MBBS,MS,MCh    +919216512636    rajsarakshi@yahoo.co.in   
Contact: Sunil Shenvi, MBBS,MS    +919855636559    reach_sunny05@yahoo.co.in   
PGIMER Recruiting
Chandigarh, India, 160012
Contact: Rajesh Gupta, MBBS,MS, M Ch    +91-9216512636    rajsarakshi@yahoo.co.in   
Contact: Sunil Shenvi, MBBS,MS    +91-9855636559    reach_sunny05@yahoo.co.in   
Principal Investigator: Rajesh Gupta, MBBS,MS, MCh         
Sub-Investigator: Sunil Shenvi, MBBS, MS         
Sub-Investigator: Madhu Khullar, PhD         
Sub-Investigator: Mandeep Kang, MBBS, MD         
Sub-Investigator: Deepak K Bhasin, MBBS, MD, DM         
Sub-Investigator: Rajinder Singh, MBBS, MS         
Sub-Investigator: Surinder S Rana, MBBS,MD,DM         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Rajesh Gupta, MBBS,MS, MCh PGIMER
  More Information

No publications provided

Responsible Party: Rajesh Gupta, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01527084     History of Changes
Other Study ID Numbers: 8760PG11
Study First Received: January 21, 2012
Last Updated: February 3, 2012
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 22, 2014