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Enhanced Recovery in Acute Pancreatitis (ASERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813876
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Bechien U. Wu, Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date May 30, 2017
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Time to tolerance of oral refeeding [ Time Frame: Up to 7 days ]
Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Time to disease resolution [ Time Frame: Up to 30 days ]
    Acute Pancreatitis Clinical Activity Index score<50
  • Satisfaction with inpatient hospital care [ Time Frame: 30 days post-hospitalization ]
    Comparison of overall and pain management satisfaction score based on validated survey instrument
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhanced Recovery in Acute Pancreatitis
Official Title  ICMJE Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
Brief Summary Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Acute Pancreatitis
Intervention  ICMJE Other: Enhanced recovery protocol
Study Arms  ICMJE
  • Experimental: Enhanced recovery
    Enhanced recovery protocol for nursing, diet and analgesic regimen
    Intervention: Other: Enhanced recovery protocol
  • No Intervention: Standard care
    Standard care arm
Publications * Dong E, Chang JI, Verma D, Butler RK, Villarin CK, Kwok KK, Chen W, Wu BU. Enhanced Recovery in Mild Acute Pancreatitis: A Randomized Controlled Trial. Pancreas. 2019 Feb;48(2):176-181. doi: 10.1097/MPA.0000000000001225.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
46
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2017
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging

Exclusion Criteria:

  • • Severe acute pancreatitis defined as the presence of any of the following:

    • Organ failure (oxygen saturation<90% on room air, mean arterial pressure<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine>2.0, Glasgow coma score<15)
    • Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate

      • Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization
      • Abdominal surgery within 60 days prior to hospitalization
      • History of gastrointestinal motility disorder
      • Inflammatory bowel disease
      • Chronic comorbid illness including but not limited to >New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission.
      • Documented allegy to any of the following medications: dilaudid, Tylenol
      • Patients transferred from an outside hospital for ongoing care
      • Non-English speaking patients for whom an appropriate language interpretor cannot be identified.
      • Pregnant women will be excluded from participation in this phase IIb trial given the limited projected sample size and rarity of this condition during pregnancy.
      • Minors (patients <18 years of age) will not be eligible for study inclusion. The interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. However, the safety and efficacy of these treatments in the pediatric population has not been established.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813876
Other Study ID Numbers  ICMJE 10920
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bechien U. Wu, Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bechien U Wu, MD, MPH Kaiser Permanente Southern California, Los Angeles Medical Center
PRS Account Kaiser Permanente
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP