Acute PancreatitisPADI_2NCT05360797
Acute PAncreatitis and Home Care vs. Hospital Admission Study
A study testing Outpatient, Medical home care and Hospitalization in people with Acute Pancreatitis and Home Care, run by Elena Ramírez-Maldonado.
Trial summary
Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis, Home Care
- What is being tested?
- Outpatient, Medical home care and Hospitalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 31 Jul 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
- age > 18 years, sign consent form.
Who cannot join
- pregnant o breastfeeding women.
- abdominal pain lasting >96 horas before admission.
- the possibility of poor oral intake for reasons other than AP.
- Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
- Chronic pancreatitis.
- ASA ≥3.
- Randomization lesser the 24 hours after randomization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis
Acute pancreatitis (AP) is one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.
With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.
Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.
Read the detailed description
This is prospective, randomized, controlled, multicentre trial.
OBJECTIVES
Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.
METHODS
Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.
The primary and several secondary endpoints will be obtained:
- Treatment failure rate (the primary endpoint).
- Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.
- Relapse pain.
- Diet intolerance.
- Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
- Pain and Analgesic requirement.
- Local complications including pancreatic necrosis, abscess, pseudocyst.
- Health costs
- Patient satisfaction
- Conditions
- Acute Pancreatitis, Home Care
- Being tested
- Outpatient, Medical home care, Hospitalization
- Keywords
- Pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OutpatientOther
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.
Medical home careOther
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.
HospitalizationOther
After a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient | Experimental | The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center. Receives: Other: Outpatient |
| Medical home care | Experimental | The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center. Receives: Other: Medical home care |
| Hospitalization | Active comparator | The mild AP patient is hospitalized Receives: Other: Hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The treatment failure rate
Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality
Measured: 30 days
Secondary outcomes (8)
Relapse of abdominal pain
Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
Measured: 30 days
Diet tolerance
Patient can eat at least 50% of the meals
Measured: 30 days
Systemic Inflammatory Response Syndrome (SIRS) Score
SIRS is a simple clinical score, ranging from 0-4, that utilizes objective, routine clinical parameters (body temperature, heart rate, respiratory rate or arterial carbon dioxide tension and white blood count) that directly reflect the underlying inflammatory response. A lower change in SIRS score (negative number) indicates a better outcome (less inflammation).
Measured: 4 days
Number of Participants who Development of Organ Failure
Including respiratory, renal and cardiovascular failures defined as modified Marshal score of equal and greater than 2. The minimum and maximum values in the modified Marshal score for each organ failure range from 0 to 4 with a higher value representing worse outcomes.
Measured: 4 days
Mortality
Enrolled subjects that died. A death indicates a worse outcome.
Measured: 30 days
Hospital admission
The AP patient needs hospital admission due to treatment failure
Measured: 30 days
Satisfaction medical / hospital care
patient satisfaction is asessed comparing management with and without admittance to the hospital. Will be assessed Patient satisfaction feedback (PSF). Scale: Strongly agree, Agree, Not sure, Disagree, Strongly disagree.
Measured: 30 days
Health costs
The costs in euros caused by diagnosis, treatment, stay in the emergency room, complications and follow-up
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ramdomized
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elena Ramírez-Maldonado
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Consorci Sanitari del Maresme
- Responsible party
- Sponsor-investigator, Elena Ramírez-Maldonado, Hospital Universitari Joan XXIII de Tarragona.
- Investigators
- Elena Ramírez-Maldonado, PhD, Principal investigator, Hospital Universitari Joan XXIIIRosa Jorba-Martin, PhD, Principal investigator, Hospital Universitari Joan XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360797
- Sponsor's protocol ID
- PADI_2
- Acronym
- PADI_2
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocolo will be shared
Publications
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.
PubMed 24854612Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
PubMed 24054878Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
PubMed 27007094Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.
PubMed 25973947Ramirez-Maldonado E, Lopez Gordo S, Pueyo EM, Sanchez-Garcia A, Mayol S, Gonzalez S, Elvira J, Memba R, Fondevila C, Jorba R. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial). Ann Surg. 2021 Aug 1;274(2):255-263. doi: 10.1097/SLA.0000000000004596.
PubMed 33196485Pando E, Alberti P, Mata R, Gomez MJ, Vidal L, Cirera A, Dopazo C, Blanco L, Gomez C, Caralt M, Balsells J, Charco R. Early Changes in Blood Urea Nitrogen (BUN) Can Predict Mortality in Acute Pancreatitis: Comparative Study between BISAP Score, APACHE-II, and Other Laboratory Markers-A Prospective Observational Study. Can J Gastroenterol Hepatol. 2021 Mar 22;2021:6643595. doi: 10.1155/2021/6643595. eCollection 2021.
PubMed 33824864Ramirez-Maldonado E, Rodrigo-Rodrigo M, Lopez Gordo S, Sanchez A, Coronado Llanos D, Sanchez R, Vaz J, Fondevila C, Jorba-Martin R; Catalan Pancreatitis Collaborative Group. Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial). BMJ Open. 2023 Jun 28;13(6):e071265. doi: 10.1136/bmjopen-2022-071265.
PubMed 37380212
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT05360797
- Acronym / sponsor ID
- PADI_2 / PADI_2
- Conditions
- Acute Pancreatitis, Home Care
- Keywords
- Pancreatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Elena Ramírez-MaldonadoUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Consorci Sanitari del Maresme
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 4 May 2022 (actual)
- 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 one of the most common reason for hospitalization among gastrointestinal diseases in U.S.. The costs caused by severe AP are higher than mild AP. Nevertheless, approximately 70% of hospital admissions for AP are mild cases, if health cost saving is to be realized, it would be by lowering the cost of managing patients with mild AP without affecting patient's safety and satisfaction.
With the PADI-1 study, where it was possible to confirm the benefits of an early diet, the rapid recovery of patients with mild AP and the reduction of hospital costs, now a new scope is to be given in the treatment of patients with this pathology.
Considering the application of predictive factors of AP severity, and being sure of diagnosing mild AP, a study of home care versus hospitalization for patients with mild AP is proposed. Based on the hypothesis that outpatient care of mild AP patients would be as sage and affective as hospitalization, the aim this study is to campare the results of 3 different strategies of treatment of patients with AP mild. Additionally, satisfaction patient and costs will be analyzed.
Detailed description
This is prospective, randomized, controlled, multicentre trial.
OBJECTIVES
Primary objective Compare the results of 3 different strategies for the management of patients with mild acute pancreatitis (AP) and to analyze differences in satisfaction patients and economic costs.
METHODS
Patients with mild AP will be randomly in three groups: group A: outpatient treatment, group B: medical home care and group C: hospitalization.
The primary and several secondary endpoints will be obtained:
- Treatment failure rate (the primary endpoint).
- Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.
- Relapse pain.
- Diet intolerance.
- Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
- Pain and Analgesic requirement.
- Local complications including pancreatic necrosis, abscess, pseudocyst.
- Health costs
- Patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Ramdomized
| Arm | Type | Receives |
|---|---|---|
| Outpatient | Experimental | Other: OutpatientThe Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center. |
| Medical home care | Experimental | Other: Medical home careThe mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center. |
| Hospitalization | Active comparator | Other: HospitalizationThe mild AP patient is hospitalized |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI).
- age > 18 years, sign consent form.
Key exclusion criteria (7 listed)
- pregnant o breastfeeding women.
- abdominal pain lasting >96 horas before admission.
- the possibility of poor oral intake for reasons other than AP.
- Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
- Chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OutpatientAfter a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center. | Other | Outpatient |
| Medical home careAfter a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center. | Other | Medical home care |
| HospitalizationAfter a 24-hour stay in the emergency department, the predictive factors of severity evaluation and the diagnosis of mild acute pancreatitis is confirmed, the patient is hospitalized with usual treatment (PADI_1) in each center. | Other | Hospitalization |
Primary outcome
The treatment failure rate
Time frame: 30 days
Treatment failure is defined as persistence, increase or recurrence of abdominal pain, and or intolerance diet, hospital admission, and mortality
8 secondary outcomes
Relapse of abdominal pain
Time frame: 30 days
Diet tolerance
Time frame: 30 days
Systemic Inflammatory Response Syndrome (SIRS) Score
Time frame: 4 days
Number of Participants who Development of Organ Failure
Time frame: 4 days
Mortality
Time frame: 30 days
Hospital admission
Time frame: 30 days
Satisfaction medical / hospital care
Time frame: 30 days
Health costs
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Results publication: 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.
- Results publication: PubMed 24054878Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.
- Results publication: PubMed 27007094Greenberg JA, Hsu J, Bawazeer M, Marshall J, Friedrich JO, Nathens A, Coburn N, May GR, Pearsall E, McLeod RS. Clinical practice guideline: management of acute pancreatitis. Can J Surg. 2016 Apr;59(2):128-40. doi: 10.1503/cjs.015015.
- Results publication: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Results publication: PubMed 25973947Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.
- Results publication: PubMed 33196485Ramirez-Maldonado E, Lopez Gordo S, Pueyo EM, Sanchez-Garcia A, Mayol S, Gonzalez S, Elvira J, Memba R, Fondevila C, Jorba R. Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial). Ann Surg. 2021 Aug 1;274(2):255-263. doi: 10.1097/SLA.0000000000004596.
- Results publication: PubMed 33824864Pando E, Alberti P, Mata R, Gomez MJ, Vidal L, Cirera A, Dopazo C, Blanco L, Gomez C, Caralt M, Balsells J, Charco R. Early Changes in Blood Urea Nitrogen (BUN) Can Predict Mortality in Acute Pancreatitis: Comparative Study between BISAP Score, APACHE-II, and Other Laboratory Markers-A Prospective Observational Study. Can J Gastroenterol Hepatol. 2021 Mar 22;2021:6643595. doi: 10.1155/2021/6643595. eCollection 2021.
- Derived from this study: PubMed 37380212Ramirez-Maldonado E, Rodrigo-Rodrigo M, Lopez Gordo S, Sanchez A, Coronado Llanos D, Sanchez R, Vaz J, Fondevila C, Jorba-Martin R; Catalan Pancreatitis Collaborative Group. Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial). BMJ Open. 2023 Jun 28;13(6):e071265. doi: 10.1136/bmjopen-2022-071265.
- Individual participant dataSharing planned: Yes. Study protocolo will be shared
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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.
Elena Ramírez-Maldonado, PhD principal investigator
Hospital Universitari Joan XXIII
Rosa Jorba-Martin, PhD principal investigator
Hospital Universitari Joan XXIII
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient, Medical home care and Hospitalization in people with Acute Pancreatitis and Home Care, run by Elena Ramírez-Maldonado.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Ramírez-Maldonado, PhD (977295800 ext. 5824, padibarcelona@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The treatment failure 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 NCT05360797, which also lists 8 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 4 May 2022.