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

Primary Purpose

Acute Pancreatitis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control
Experimental
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pancreatitis focused on measuring acute pancreatitis, mild pancreatitis, outpatient protocol

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 <100mg/dL or white blood cell count < 14000)
  • 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.

Sites / Locations

  • Hospital Universitari de BellvitgeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

HOSPI Group

HOME Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Hospital readmission during the first 30 days after diagnosis
Number of patients readmitted to the hospital during the first 30 days after diagnosis.
Cumulative incidence of mortality during the first 30 days after diagnosis
30-day mortality
Estimated costs of each intervention
Median (95%CI) Charlson Comorbidity Score per group
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score

Full Information

First Posted
July 11, 2022
Last Updated
April 22, 2023
Sponsor
Hospital Universitari de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT05473260
Brief Title
Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis
Acronym
RHINO
Official Title
Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
July 16, 2025 (Anticipated)
Study Completion Date
July 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
acute pancreatitis, mild pancreatitis, outpatient protocol

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HOSPI Group
Arm Type
Active Comparator
Arm Description
Patients with mild acute pancreatitis randomized to in-hospital care.
Arm Title
HOME Group
Arm Type
Experimental
Arm Description
Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
HOSPIT
Intervention Description
In-patient care.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
HOME
Intervention Description
Early discharge and outpatient follow-up.
Primary Outcome Measure Information:
Title
7-day (after randomization) treatment failure rate
Description
Treatment failure is defined as a VAS >3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis
Description
Complications include, but are not limited to, abscess formation, pseudocysts, local necrosis, kidney failure, respiratory failure.
Time Frame
30 days
Title
Hospital readmission during the first 30 days after diagnosis
Description
Number of patients readmitted to the hospital during the first 30 days after diagnosis.
Time Frame
30 days
Title
Cumulative incidence of mortality during the first 30 days after diagnosis
Description
30-day mortality
Time Frame
30 days
Title
Estimated costs of each intervention
Time Frame
7 days
Title
Median (95%CI) Charlson Comorbidity Score per group
Time Frame
7 days
Title
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juli Busquets, PhD
Phone
93 260 75 00
Email
jbusquets@bellvitgehospital.cat
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Sorribas, MD
Email
sorribasgrifell@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

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