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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | undergo surgery between days 10 - 15 after PCD |
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| Group B | Other | continued with PCD beyond 15 days and indications for surgery in them will be,
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Gupta, MBBS,MS, MCh | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | Chandigarh | 160012 | India | ||
| Postgraduate Institute of Medical Education and Research |
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| 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 |
| Chandigarh |
| 160012 |
| India |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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