Acute PancreatitisPhase 2ASERTNCT02813876
Enhanced Recovery in Acute Pancreatitis
A Phase 2 study testing Enhanced recovery protocol in people with Acute Pancreatitis, run by Kaiser Permanente at 1 site in United States.
Trial summary
Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Enhanced recovery protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 15 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging
Who cannot join
- • 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
About this study
Official title: 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.
- Conditions
- Acute Pancreatitis
- Being tested
- Enhanced recovery protocol
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery protocolOther
| Study group | Role | What they receive |
|---|---|---|
| Enhanced recovery | Experimental | Enhanced recovery protocol for nursing, diet and analgesic regimen Receives: Other: Enhanced recovery protocol |
| Standard care | No intervention | Standard care arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days
Secondary outcomes (2)
Time to disease resolution
Acute Pancreatitis Clinical Activity Index score<50
Measured: Up to 30 days
Satisfaction with inpatient hospital care
Comparison of overall and pain management satisfaction score based on validated survey instrument
Measured: 30 days post-hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bechien U. Wu, Kaiser Permanente
- Investigators
- Bechien U Wu, MD, MPH, Principal investigator, Kaiser Permanente Southern California, Los Angeles Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813876
- Sponsor's protocol ID
- 10920
- Acronym
- ASERT
- Status last verified
- May 2017
- First submitted
- 23 Jun 2016
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT02813876
- Acronym / sponsor ID
- ASERT / 10920
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced recovery | Experimental | Other: Enhanced recovery protocolEnhanced recovery protocol for nursing, diet and analgesic regimen |
| Standard care | No intervention | –Standard care arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging
Key exclusion criteria (13 listed)
- • Severe acute pancreatitis defined as the presence of any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced recovery protocol | Other | Enhanced recovery |
Primary outcome
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
2 secondary outcomes
Time to disease resolution
Time frame: Up to 30 days
Satisfaction with inpatient hospital care
Time frame: 30 days post-hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 30629020Dong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bechien U Wu, MD, MPH principal investigator
Kaiser Permanente Southern California, Los Angeles Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enhanced recovery protocol in people with Acute Pancreatitis, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to tolerance of oral refeeding (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02813876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.