Enhanced Recovery in Acute Pancreatitis (ASERT)

Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis

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

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: Enhanced recovery protocol

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Enhanced recovery; Enhanced recovery protocol for nursing, diet and analgesic regimen	Other: Enhanced recovery protocol
NO_INTERVENTION: Standard care; Standard care arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to disease resolution	Acute Pancreatitis Clinical Activity Index score<50	Up to 30 days
Satisfaction with inpatient hospital care	Comparison of overall and pain management satisfaction score based on validated survey instrument	30 days post-hospitalization

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): May 15, 2017
• Study Completion (ACTUAL): May 15, 2017

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 10920