Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis (RHINO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: Control; Other: Experimental

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.

• Study Type: Interventional
• Enrollment (Anticipated): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
      • Contact: Maria Sorribas, MD; Email: sorribasgrifell@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HOSPI Group; Patients with mild acute pancreatitis randomized to in-hospital care.	Other: Control; In-patient care.; Other Names: HOSPIT
Experimental: HOME Group; Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.	Other: Experimental; Early discharge and outpatient follow-up.; Other Names: HOME

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of mortality during the first 30 days after diagnosis	30-day mortality	30 days
Estimated costs of each intervention		7 days
Median (95%CI) Charlson Comorbidity Score per group		7 days
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
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
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score		7 days

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Anticipated): July 16, 2025
• Study Completion (Anticipated): July 16, 2025

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: acute pancreatitis; mild pancreatitis; outpatient protocol
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: RHINO-TRIAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No