CClinicalTrials.gg
CompletedNCT02813876ASERTUpdated May 30, 2017

Enhanced Recovery in Acute Pancreatitis

A Phase 2 interventional study of Enhanced recovery protocol in Acute Pancreatitis, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Kaiser Permanente · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.

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Conditions studied

  • Acute Pancreatitis

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In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 46 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Enhanced recovery

    Enhanced recovery protocol for nursing, diet and analgesic regimen

    Other: Enhanced recovery protocol

  • No intervention
    Standard care

    Standard care arm

Interventions

  • OtherEnhanced recovery protocol
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What researchers measure

Primary outcomes

  1. Time to tolerance of oral refeeding

    Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting

    Time frame: Up to 7 days

Secondary outcomes

  1. Time to disease resolution

    Acute Pancreatitis Clinical Activity Index score\<50

    Time frame: Up to 30 days

  2. Satisfaction with inpatient hospital care

    Comparison of overall and pain management satisfaction score based on validated survey instrument

    Time frame: 30 days post-hospitalization

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Study locations

1 site
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
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References and documents

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. PubMed 30629020 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02813876
Lead sponsor
Kaiser Permanente
Responsible party
Bechien U. Wu (Center for Pancreatic Care, Kaiser Permanente) — Principal investigator
First posted
Jun 27, 2016
Start date
Jun 2016
Primary completion
May 15, 2017
Completion
May 15, 2017
Last update
May 30, 2017

Study contacts

Bechien U Wu, MD, MPH
principal investigator · Kaiser Permanente Southern California, Los Angeles Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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