Home Treatment of Acute Pancreatitis

NCT01796652 | Completed

• 1 other identifier: B.30.2.BAV.0.05.05/374
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Acute interstitial pancreatitis; Home therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

  hours

Study Arms (1)

Home and hospital treatment groups

Patients were randomized into either home or hospital groups after a brief hospitalization(≤24 hours. Hospital patients were followed 5 days in hospital.Home patients were visited on 2nd,3rd and 5th days by a staff nurse and the vital signs, symptoms, and general condition were recorded and transmitted back to the attending physician. On the 7th, 14th and 30th days, the home and hospital group patients were requested to return for a follow-up clinic visit at Bezmialem, at which time an assessment of their symptoms, physical examination, and laboratory evaluation was conducted.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mild acute non-alhololic patients managed in home.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University Hospital, Gastroenterology Clinic

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 20531398 BACKGROUND

• 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.

  PMID: 22153541 BACKGROUND

• 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.

  PMID: 22470079 BACKGROUND

• 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.

  PMID: 20954281 BACKGROUND

• 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.

  PMID: 24854612 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Hakan Şentürk, Prof.

  Bezmialem Vakıf University Hospital, Gastroenterology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asc Prof

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 22, 2013
• Study Start: November 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

TU (1)