Home Treatment of Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796652
• Other study ID #: B.30.2.BAV.0.05.05/374
• Status: Completed
• Phase: N/A
• First received: February 19, 2013
• Last updated: February 21, 2013
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University Hospital, Gastroenterology Clinic	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

Rodríguez-Cerrillo M, Poza-Montoro A, Fernandez-Diaz E, Iñurrieta-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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of the study was the 30 day hospital readmission rate.	30 day hospital readmission of home and hospital groups of patients were evaluated.	30 days	Yes
Secondary	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.	Elaboration 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.	hours	Yes