NCT05473260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2025

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

July 11, 2022

Last Update Submit

April 22, 2023

Conditions

Acute Pancreatitis

Keywords

acute pancreatitismild pancreatitisoutpatient protocol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Cumulative incidence of complications secondary to acute pancreatitis during the first 30 days after diagnosis

    30 days

  • Hospital readmission during the first 30 days after diagnosis

    30 days

  • Cumulative incidence of mortality during the first 30 days after diagnosis

    30 days

  • Estimated costs of each intervention

    7 days

  • Median (95%CI) Charlson Comorbidity Score per group

    7 days

  • +1 more secondary outcomes

Study Arms (2)

HOSPI Group

ACTIVE COMPARATOR

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

Other: Control

HOME Group

EXPERIMENTAL

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

Other: Experimental

Interventions

ControlOTHER

In-patient care.

Also known as: HOSPIT
HOSPI Group
ExperimentalOTHER

Early discharge and outpatient follow-up.

Also known as: HOME
HOME Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Juli Busquets, PhD

CONTACT

93 260 75 00jbusquets@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive and General Surgeon

Study Record Dates

First Submitted

July 11, 2022

First Posted

July 25, 2022

Study Start

November 16, 2022

Primary Completion

July 16, 2025

Study Completion

July 16, 2025

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

ES(1)