Acute PAncreatitis and Home Care vs. Hospital Admission Study (PADI_2)

Elena Ramírez-Maldonado

Status: Not yet enrolling

Conditions: Home Care; Acute Pancreatitis

Treatments: Other: Outpatient; Other: Hospitalization; Other: Medical home care

Study type: Interventional

Funder types: Other

Identifiers

NCT05360797

PADI_2

Details and patient eligibility

About

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.

Full 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

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Outpatient

Experimental group

Description:

The Mild AP patient is discharged and contacted daily for 4 consecutive days by the study investigators in each center.

Treatment:

Other: Outpatient

Medical home care

Experimental group

Description:

The mild AP patient is discharged and contacted daily for 4 consecutive days by the medical home care department in each center.

Treatment:

Other: Medical home care

Hospitalization

Active Comparator group

Description:

The mild AP patient is hospitalized

Treatment:

Other: Hospitalization