Enhanced Recovery in Acute Pancreatitis (ASERT)

• ClinicalTrials.gov Identifier: NCT02813876
• Recruitment Status: Completed
• First Posted: June 27, 2016
• Last Update Posted: May 30, 2017
• Sponsor: Kaiser Permanente
• Information provided by (Responsible Party): Bechien U. Wu, Kaiser Permanente

Tracking Information

• First Submitted Date: June 23, 2016
• First Posted Date: June 27, 2016
• Last Update Posted Date: May 30, 2017
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enhanced Recovery in Acute Pancreatitis
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Condition: Acute Pancreatitis
• Intervention: Other: Enhanced recovery protocol

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2016): 46
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 15, 2017
• Actual Primary Completion Date: May 15, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02813876
• Other Study ID Numbers: 10920
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bechien U. Wu, Kaiser Permanente
• Study Sponsor: Kaiser Permanente
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bechien U Wu, MD, MPH; Kaiser Permanente Southern California, Los Angeles Medical Center

• PRS Account: Kaiser Permanente
• Verification Date: May 2017