Clinical trial NCT05360797: Acute PAncreatitis and Home Care vs. Hospital Admission Study
Official title: Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Home Care vs Hospital Admission in Patients With Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Pancreatitis
Home Care
Keywords: Pancreatitis
Lead sponsor: Hospital Universitari Joan XXIII de Tarragona.
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Consorci Sanitari del Maresme
First posted: 2022-05-04
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ramdomized
Primary purpose: TREATMENT

Brief 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 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:

1. Treatment failure rate (the primary endpoint).
2. Serum amylase, lipase, electrolytes, BUN (blood urea nitrogen), creatinine, liver function tests, and full blood count at hospital admission, 24 hours and 72 hours.
3. Relapse pain.
4. Diet intolerance.
5. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
6. Pain and Analgesic requirement.
7. Local complications including pancreatic necrosis, abscess, pseudocyst.
8. Health costs
9. Patient satisfaction

Eligibility criteria: Inclusion Criteria:

1. 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).
2. age \> 18 years, sign consent form.

Exclusion Criteria:

1. pregnant o breastfeeding women.
2. abdominal pain lasting \>96 horas before admission.
3. the possibility of poor oral intake for reasons other than AP.
4. Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology, biliar obstruction.
5. Chronic pancreatitis.
6. ASA ≥3.
7. Randomization lesser the 24 hours after randomization.

Primary outcomes:
measure: The treatment failure rate
timeFrame: 30 days
Secondary outcomes:
measure: Relapse of abdominal pain
timeFrame: 30 days
measure: Diet tolerance
timeFrame: 30 days
measure: Systemic Inflammatory Response Syndrome (SIRS) Score
timeFrame: 4 days
measure: Number of Participants who Development of Organ Failure
timeFrame: 4 days
measure: Mortality
timeFrame: 30 days
measure: Hospital admission
timeFrame: 30 days
measure: Satisfaction medical / hospital care
timeFrame: 30 days
measure: Health costs
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitari Joan XXIII
name: Elena Ramírez-Maldonado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Joan XXIII
name: Rosa Jorba-Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Working 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.
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citation: Ramirez-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.
citation: Pando 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.