Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

NCT ID: NCT05473260

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2025-07-16

Brief Summary

Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.

Detailed Description

Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support.

We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HOSPI Group

Patients with mild acute pancreatitis randomized to in-hospital care.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

In-patient care.

HOME Group

Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

Early discharge and outpatient follow-up.

Interventions

Control

In-patient care.

Intervention Type: OTHER

Experimental

Early discharge and outpatient follow-up.

Intervention Type: OTHER

Other Intervention Names

HOSPIT; HOME

Eligibility Criteria

Inclusion Criteria

Patients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:

• Abdominal pain
• Amylase or lipase 3x ULN (in blood/urine)
• Imaging tests (Ultrasound/CT scan) suggestive of acute pancreatitis.

Age ≥18 years and <80 years

Absence of potential pancreatitis-related severity criteria:

• No evidence of SIRS in the emergency room
• C-Reactive Protein levels <150mg/dL
• Marked increase in the White Blood Cell Count
• Absence of coagulopathy (INR <1.4)
• Hematocrit < 44%
• Creatinine < 170 µmol/L
• BISAP score ≤2 at the time of randomization.

Patients with good pain response to 12-hour supportive care in the ER (VAS <4) or adequate oral feeding tolerability.

Absence of local or systemic complications of acute pancreatitis on imaging tests.

Adequate cognitive capacity and without any previous diagnose of psychiatric disease.

Patients who meet each participating hospital home care criteria. Patients who give their written informed consent to participate.

Exclusion Criteria

Past medical history of pancreatic disease:

• Known or newly diagnosed chronic pancreatitis (Wirsung dilation or pancreatic calcifications in previous imaging tests)
• Patients with recurrent acute pancreatitis (>3 episodes/year) or an episode of acute pancreatitis <1 month ago.
• Acute pancreatitis after endoscopic retrograde cholangiography.
• Hyperbilirubinemia >3x ULN

Comorbidities that required previous hospitalization (myocardial infarction, liver cirrhosis, chronic kidney disease, or chronic lung disease).

BMI ≥35 Kg/m2 Patients who refuse to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

BUSQUETS, JULI

Digestive and General Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Juli Busquets, PhD

Role: CONTACT

jbusquets@bellvitgehospital.cat

93 260 75 00

Facility Contacts

Maria Sorribas, MD

Role: primary

sorribasgrifell@gmail.com

Other Identifiers

RHINO-TRIAL

Identifier Type: -

Identifier Source: org_study_id