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Completed

NCT Number: NCT01527084

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

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

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PGIMER, Chandigarh, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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)

Primary outcomes

  1. Mortality

    Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks

  2. Reversal of existing organ failure

    Time frame: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks

  3. 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

  4. Locoregional complications

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2012
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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