Clinical trial NCT02813876: Enhanced Recovery in Acute Pancreatitis
Official title: Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pancreatitis
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: Time to tolerance of oral refeeding
timeFrame: Up to 7 days
Secondary outcomes:
measure: Time to disease resolution
timeFrame: Up to 30 days
measure: Satisfaction with inpatient hospital care
timeFrame: 30 days post-hospitalization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente Southern California, Los Angeles Medical Center
name: Bechien U Wu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.