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Home Treatment of Acute Pancreatitis

A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01796652
Enrollment
84
Registered
2013-02-22
Start date
2011-11-30
Completion date
2012-06-30
Last updated
2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Keywords

Acute interstitial pancreatitis, Home therapy

Brief summary

Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.

Detailed description

Between 11/11-5/12, 84 patients with mild NAAP were randomized to home or hospital groups after a short (≤24 hours) hospital stay. AP was defined as ≥2 or more of the following: characteristic abdominal pain, amylase and/or lipase ≥3X the upper limit of normal, and/or imaging findings. Patients with an Imrie's score ≤5 and a harmless acute pancreatitis score (HAPS) ≤2 were included. Patients in both groups received intravenous lactated Ringer for 3 days and pain was treated with intramuscular diclofenac. A nurse visited all patients in the home group on the 2nd, 3rd and 5th day. All patients recalled for follow-up on the 7th, 14th, and 30th days.

Interventions

None listed

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis * Presentation within 48 hours of symptom onset * Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital * Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis.

Exclusion criteria

* The presence of organ failure by the Atlanta criteria on the first day of presentation * The presence of clinical signs and/or symptoms of sepsis * Alcoholic acute pancreatitis * A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications * Coagulopathy (international normalized ratio \>1, and/or platelet count \<50,000/mm3 * Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome of the study was the 30 day hospital readmission rate.30 days30 day hospital readmission of home and hospital groups of patients were evaluated.

Secondary

MeasureTime frameDescription
Other outcomes evaluated included the duration of abdominal pain and time to resumption of an oral diet, both measured in hours from the time of presentation.hoursElaboration time of abdominal pain in home and hospital group patients as hour from the admission time to ICU. Time to resumption of an oral diet measured from the time of presentation.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026