Clinical trial NCT01796652: Home Treatment of Acute Pancreatitis
Official title: A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pancreatitis
Keywords: Acute interstitial pancreatitis
Home therapy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mild acute non-alhololic patients managed in home.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The primary outcome of the study was the 30 day hospital readmission rate.
timeFrame: 30 days
Secondary outcomes:
measure: 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.
timeFrame: hours
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital, Gastroenterology Clinic
Study officials:
affiliation: Bezmialem Vakıf University Hospital, Gastroenterology Clinic
name: Hakan Şentürk, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitlock TL, Repas K, Tignor A, Conwell D, Singh V, Banks PA, Wu BU. Early readmission in acute pancreatitis: incidence and risk factors. Am J Gastroenterol. 2010 Nov;105(11):2492-7. doi: 10.1038/ajg.2010.234. Epub 2010 Jun 8.
citation: Rodriguez-Cerrillo M, Poza-Montoro A, Fernandez-Diaz E, Inurrieta-Romero A, Matesanz-David M. Home treatment of patients with acute cholecystitis. Eur J Intern Med. 2012 Jan;23(1):e10-3. doi: 10.1016/j.ejim.2011.07.012. Epub 2011 Aug 27.
citation: van Baal MC, Besselink MG, Bakker OJ, van Santvoort HC, Schaapherder AF, Nieuwenhuijs VB, Gooszen HG, van Ramshorst B, Boerma D; Dutch Pancreatitis Study Group. Timing of cholecystectomy after mild biliary pancreatitis: a systematic review. Ann Surg. 2012 May;255(5):860-6. doi: 10.1097/SLA.0b013e3182507646.
citation: Andersson B, Pendse ML, Andersson R. Pancreatic function, quality of life and costs at long-term follow-up after acute pancreatitis. World J Gastroenterol. 2010 Oct 21;16(39):4944-51. doi: 10.3748/wjg.v16.i39.4944.
citation: Ince AT, Senturk H, Singh VK, Yildiz K, Danalioglu A, Cinar A, Uysal O, Kocaman O, Baysal B, Gurakar A. A randomized controlled trial of home monitoring versus hospitalization for mild non-alcoholic acute interstitial pancreatitis: a pilot study. Pancreatology. 2014 May-Jun;14(3):174-8. doi: 10.1016/j.pan.2014.02.007. Epub 2014 Mar 14.