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Clinical Trials/NCT02813876
NCT02813876
Completed
Phase 2

Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis

Kaiser Permanente1 site in 1 country46 target enrollmentJune 2016

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Acute Pancreatitis
Sponsor
Kaiser Permanente
Enrollment
46
Locations
1
Primary Endpoint
Time to tolerance of oral refeeding
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 15, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bechien U. Wu

Center for Pancreatic Care

Kaiser Permanente

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Satisfaction with inpatient hospital care(30 days post-hospitalization)
  • Time to disease resolution(Up to 30 days)

Study Sites (1)

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