Acute PancreatitisNCT01796652
Home Treatment of Acute Pancreatitis
An observational study of Acute Pancreatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2011to Jun 2012
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Mild acute non-alhololic patients managed in home.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University Hospital, Gastroenterology Clinic
Istanbul, 34093
About this study
Official title: A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis
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.
Read the 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.
- Conditions
- Acute Pancreatitis
- Keywords
- Acute interstitial pancreatitis, Home therapy
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Bezmialem Vakif UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Tüzün İnce, Bezmialem Vakif University
- Investigators
- Hakan Şentürk, Prof., Principal investigator, Bezmialem Vakıf University Hospital, Gastroenterology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796652
- Sponsor's protocol ID
- B.30.2.BAV.0.05.05/374
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20531398Rodriguez-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.
PubMed 22153541van 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.
PubMed 22470079Andersson 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.
PubMed 20954281Ince 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.
PubMed 24854612
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis
- ClinicalTrials.gov ID
- NCT01796652
- Acronym / sponsor ID
- B.30.2.BAV.0.05.05/374
- Conditions
- Acute Pancreatitis
- Keywords
- Acute interstitial pancreatitis, Home therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Feb 2013 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild acute non-alhololic patients managed in home.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome of the study was the 30 day hospital readmission rate.
Time frame: 30 days
30 day hospital readmission of home and hospital groups of patients were evaluated.
1 secondary outcome
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.
Time frame: hours
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 22 Feb 2013.
- Background: PubMed 20531398Whitlock 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.
- Background: PubMed 22153541Rodriguez-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.
- Background: PubMed 22470079van 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.
- Background: PubMed 20954281Andersson 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.
- Derived from this study: PubMed 24854612Ince 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.
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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.
Hakan Şentürk, Prof. principal investigator
Bezmialem Vakıf University Hospital, Gastroenterology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 22 Feb 2013. 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 Turkey (Türkiye). 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.
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?
The primary outcome of the study was the 30 day hospital readmission rate. (time frame: 30 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 NCT01796652, which also lists 5 linked publications.
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 22 Feb 2013.