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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
University Clinical Center Tuzla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Necrotizing pancreatitis, Sepsis, Infection, Drainage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. fluid collections within two weeks of disease onset;
  2. single- or multi-organ failure;
  3. 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:

  1. patients without APD interventions;
  2. patients who underwent necrosectomy directly after APD without PCD as a bridge therapy;
  3. previous percutaneous drainage or surgical necrosectomy during the episode of pancreatitis;
  4. 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

    First Posted
    December 31, 2015
    Last Updated
    October 27, 2016
    Sponsor
    University Clinical Center Tuzla
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    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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