Enhanced Recovery in Acute Pancreatitis (ASERT)
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ClinicalTrials.gov Identifier: NCT02813876 |
Recruitment Status :
Completed
First Posted : June 27, 2016
Last Update Posted : May 30, 2017
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Condition or disease | Intervention/treatment | Phase |
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Acute Pancreatitis | Other: Enhanced recovery protocol | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 46 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | May 15, 2017 |
Actual Study Completion Date : | May 15, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Enhanced recovery
Enhanced recovery protocol for nursing, diet and analgesic regimen
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Other: Enhanced recovery protocol |
No Intervention: Standard care
Standard care arm
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- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging
Exclusion Criteria:
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• 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)
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813876
United States, California | |
Kaiser Permanente Los Angeles Medical Center | |
Los Angeles, California, United States, 90027 |
Principal Investigator: | Bechien U Wu, MD, MPH | Kaiser Permanente Southern California, Los Angeles Medical Center |
Responsible Party: | Bechien U. Wu, Center for Pancreatic Care, Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT02813876 |
Other Study ID Numbers: |
10920 |
First Posted: | June 27, 2016 Key Record Dates |
Last Update Posted: | May 30, 2017 |
Last Verified: | May 2017 |
Pancreatitis Pancreatic Diseases Digestive System Diseases |