Acute PancreatitisRHINONCT05473260
Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis
A study testing Experimental in people with Acute Pancreatitis, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteSpain
- Study dates
- 16 Nov 2022to 16 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Maria Sorribas, MD, sorribasgrifell@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Control, Experimental
- Keywords
- acute pancreatitis, mild pancreatitis, outpatient protocol
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called HOSPIT
In-patient care.
ExperimentalOther
Also called HOME
Early discharge and outpatient follow-up.
| Study group | Role | What they receive |
|---|---|---|
| HOSPI Group | Active comparator | Patients with mild acute pancreatitis randomized to in-hospital care. Receives: Other: Control |
| HOME Group | Experimental | Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up. Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 30 days
Cumulative incidence of mortality during the first 30 days after diagnosis
30-day mortality
Measured: 30 days
Estimated costs of each intervention
Measured: 7 days
Median (95%CI) Charlson Comorbidity Score per group
Measured: 7 days
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start16 Nov 2022
- Primary completion16 Jul 2025 (estimated)
- Study completion16 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BUSQUETS, JULI, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473260
- Sponsor's protocol ID
- RHINO-TRIAL
- Acronym
- RHINO
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis. A Pilot Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05473260
- Acronym / sponsor ID
- RHINO / RHINO-TRIAL
- Conditions
- Acute Pancreatitis
- Keywords
- acute pancreatitis, mild pancreatitis, outpatient protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 16 Jul 2025 (estimated)
- Study completion
- 16 Jul 2025 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOSPI Group | Active comparator | Other: ControlPatients with mild acute pancreatitis randomized to in-hospital care. |
| HOME Group | Experimental | Other: ExperimentalPatients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: HOSPITIn-patient care. | Other | HOSPI Group |
| ExperimentalAlso: HOMEEarly discharge and outpatient follow-up. | Other | HOME Group |
Primary outcome
7-day (after randomization) treatment failure rate
Time frame: 7 days
Treatment failure is defined as a VAS >3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).
6 secondary outcomes
Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis
Time frame: 30 days
Hospital readmission during the first 30 days after diagnosis
Time frame: 30 days
Cumulative incidence of mortality during the first 30 days after diagnosis
Time frame: 30 days
Estimated costs of each intervention
Time frame: 7 days
Median (95%CI) Charlson Comorbidity Score per group
Time frame: 7 days
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Acute Pancreatitis, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juli Busquets, PhD (93 260 75 00, jbusquets@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day (after randomization) treatment failure rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.