Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Not Applicable

Recruiting

• Conditions: Acute Pancreatitis
• Interventions: Other: Control; Other: Experimental

• Registration Number: NCT05473260
• Lead Sponsor: Hospital Universitari de Bellvitge

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.

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2022-11-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-22
• Last Update Posted: 2023-04-25
• Primary Completion: 2025-07-16
• Study Completion: 2025-07-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HOSPI Group	Control	Patients with mild acute pancreatitis randomized to in-hospital care.
HOME Group	Experimental	Patients with mild acute pancreatitis randomized to early discharge and outpatient clinic follow-up.

Primary Outcome Measures

Name	Time	Method
7-day (after randomization) treatment failure rate	7 days	Treatment failure is defined as a VAS \>3 and/or oral feeding intolerance (nausea, repeated vomiting episodes, early satiety).

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis	30 days	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	30 days	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 days	30-day mortality
Estimated costs of each intervention	7 days
Median (95%CI) Charlson Comorbidity Score per group	7 days
Median (95%CI) EuroQoL 5 Dimensions Quality of Life Score	7 days

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain