Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— RHINO  

Official title:

Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473260
• Other study ID #: RHINO-TRIAL
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: July 16, 2025

Study information

• Verified date: April 2023
• Source: Hospital Universitari de Bellvitge
• Contact: Juli Busquets, PhD
• Phone: 93 260 75 00
• Email: jbusquets[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: July 16, 2025
• Est. primary completion date: July 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• Control
In-patient care.
• Experimental
Early discharge and outpatient follow-up.

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day (after randomization) treatment failure rate	Treatment failure is defined as a VAS >3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).	7 days
Secondary	Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis	Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure.	30 days
Secondary	Hospital readmission during the first 30 days after diagnosis	Number of patients readmitted to the hospital during the first 30 days after diagnosis.	30 days
Secondary	Cumulative incidence of mortality during the first 30 days after diagnosis	30-day mortality	30 days
Secondary	Estimated costs of each intervention		7 days
Secondary	Median (95%CI) Charlson Comorbidity Score per group		7 days
Secondary	Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score		7 days