Acute PAncreatitis and Home Care vs. Hospital Admission Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acute Pancreatitis Home Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Ramdomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Outpatient

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

Group Type EXPERIMENTAL

Outpatient

Intervention Type OTHER

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 care

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

Group Type EXPERIMENTAL

Medical home care

Intervention Type OTHER

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.

Hospitalization

The mild AP patient is hospitalized

Group Type ACTIVE_COMPARATOR

Hospitalization

Intervention Type OTHER

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.

Interventions

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Outpatient

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.

Intervention Type OTHER

Medical home care

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.

Intervention Type OTHER

Hospitalization

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No