Management of Pancreatitis: the Role of Supportive and Drainage Treatment

Study Overview
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Brief Summary
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This study aims to investigate the natural clinical course, diagnostic possibilities and treatment modalities in moderately severe (MSAP) and severe acute pancreatitis (SAP). The management of severe acute pancreatitis varies with the severity and depends on the type of complication that requires treatment. Although no universally accepted treatment algorithm exists, the step-up approach using close monitoring, percutaneous or endoscopic drainage, followed by minimally invasive video-assisted retroperitoneal debridement has demonstrated to produce superior outcomes to traditional open necrosectomy and may be considered as the reference standard intervention for this disorder.

Detailed Description
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Despite overall reduced mortality in the last decade, MSAP and SAP are devastating diseases associated with mortality ranging from less than 10% to as high as 85%, according to various studies. The management of SAP is complicated because of the limited understanding of the pathogenesis and multi-causality of the disease, uncertainties in outcome prediction and few effective treatment modalities. Generally, sterile necrosis can be managed conservatively in the majority of cases with a low mortality rate (12%). However, infection of pancreatic necrosis can be observed in 25%-70% of patients with necrotizing disease; it is generally accepted that the infected non-vital tissue should be removed to control the sepsis. Laparotomy and immediate debridement of the infected necrotic tissue have been the gold standard treatment for decades. However, several reports have shown that early surgical intervention for pancreatic necrosis could result in a worse prognosis compared to cases where surgery is delayed or avoided. Therefore, several groups worldwide have developed new, minimally invasive approaches for managing infected necrotizing pancreatitis. The applicability of these techniques depends on the availability of specialized expertise and a multidisciplinary team dedicated to the management of SAP and its complications.

Official Title
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Management of Moderate and Severe Forms of Acute Pancreatitis

Conditions
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Pancreatitis

Intervention / Treatment
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* Procedure: Percutaneous catheter drainage
* Procedure: Abdominal paracentesis evacuation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fluid collections within two weeks of disease onset; single- or multi-organ failure; CTSI > = 7 (initial CT performed within 7 days after the onset of disease.); and (4) acute physiology and chronic health evaluation (APACHE) II score > = 8. Exclusion Criteria: patients without APD interventions; patients who underwent necrosectomy directly after APD without PCD as a bridge therapy; previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis; previous exploratory laparotomy for acute abdomen and intraoperative diagnosis of AP.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous catheter drainage group<br>Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis | Procedure: Percutaneous catheter drainage<br>* Depending on the operator experience, tandem trocar technique or Seldinger technique can be used. If the Seldinger technique is used, then the catheter tract should be sequentially dilated over a guidewire. Access routes that avoid crossing the bowel and other intervening organs, or major mesenteric, peripancreatic, or retroperitoneal blood vessels are selected to minimize the risk of bacterial contamination and hemorrhage. Successful percutaneous treatment of necrotic collections of the pancreas depends on several important factors. Catheters often need to remain in place for several weeks and sometimes months; hence, close follow-up is required.<br>|
| Active Comparator: Abdominal paracentesis evacuation group<br>Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis | Procedure: Abdominal paracentesis evacuation<br>* Evacuation of peritoneal ascitic fluid using percutaneous catheters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants converted to more aggressive treatment |  | An average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring PCD after initial APD |  | An average of 1 year | 
| Morbidity and mortality in patients requiring PCD |  | An average of 1 year | 
| Number of PCD interventions required |  | An average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Necrotizing pancreatitis, Sepsis, Infection, Drainage