Management of Pancreatitis: the Role of Supportive and Drainage Treatment
Primary Purpose
Pancreatitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous catheter drainage
Abdominal paracentesis evacuation
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis focused on measuring Necrotizing pancreatitis, Sepsis, Infection, Drainage
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Percutaneous catheter drainage group
Abdominal paracentesis evacuation group
Arm Description
Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis
Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis
Outcomes
Primary Outcome Measures
Number of participants converted to more aggressive treatment
Secondary Outcome Measures
Proportion of patients requiring PCD after initial APD
Morbidity and mortality in patients requiring PCD
Number of PCD interventions required
Full Information
NCT ID
NCT02648815
First Posted
December 31, 2015
Last Updated
October 27, 2016
Sponsor
University Clinical Center Tuzla
1. Study Identification
Unique Protocol Identification Number
NCT02648815
Brief Title
Management of Pancreatitis: the Role of Supportive and Drainage Treatment
Official Title
Management of Moderate and Severe Forms of Acute Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinical Center Tuzla
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis
Keywords
Necrotizing pancreatitis, Sepsis, Infection, Drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous catheter drainage group
Arm Type
Active Comparator
Arm Description
Percutaneous catheter drainage (PCD) of necrotic tissue and pathological collections formed during acute pancreatitis
Arm Title
Abdominal paracentesis evacuation group
Arm Type
Active Comparator
Arm Description
Abdominal paracentesis drainage (APD) of peritoneal fluid during acute pancreatitis
Intervention Type
Procedure
Intervention Name(s)
Percutaneous catheter drainage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Abdominal paracentesis evacuation
Intervention Description
Evacuation of peritoneal ascitic fluid using percutaneous catheters
Primary Outcome Measure Information:
Title
Number of participants converted to more aggressive treatment
Time Frame
An average of 1 year
Secondary Outcome Measure Information:
Title
Proportion of patients requiring PCD after initial APD
Time Frame
An average of 1 year
Title
Morbidity and mortality in patients requiring PCD
Time Frame
An average of 1 year
Title
Number of PCD interventions required
Time Frame
An average of 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enver Zerem, MD.PhD
Organizational Affiliation
University Clinical Center Tuzla
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25320523
Citation
Zerem E. Treatment of severe acute pancreatitis and its complications. World J Gastroenterol. 2014 Oct 14;20(38):13879-92. doi: 10.3748/wjg.v20.i38.13879.
Results Reference
result
PubMed Identifier
21478061
Citation
Zerem E, Imamovic G, Susic A, Haracic B. Step-up approach to infected necrotising pancreatitis: a 20-year experience of percutaneous drainage in a single centre. Dig Liver Dis. 2011 Jun;43(6):478-83. doi: 10.1016/j.dld.2011.02.020. Epub 2011 Apr 8.
Results Reference
result
PubMed Identifier
19444515
Citation
Zerem E, Imamovic G, Omerovic S, Imsirovic B. Randomized controlled trial on sterile fluid collections management in acute pancreatitis: should they be removed? Surg Endosc. 2009 Dec;23(12):2770-7. doi: 10.1007/s00464-009-0487-2. Epub 2009 May 15.
Results Reference
result
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Management of Pancreatitis: the Role of Supportive and Drainage Treatment
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