Health Trials

Outpatient Versus Inpatient Management of Mild Acute Pancreatitis

ConditionsAcute Pancreatitis (AP)Biliary Pancreatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for Traumatology and Major Burns, Ben Arous

About this trial

Acute pancreatitis is a sudden inflammation of the pancreas that causes severe abdominal pain. Most cases are mild and get better within a few days with basic supportive treatment such as fluids and pain relief. Currently, all patients with acute pancreatitis are admitted to hospital, even those with a very low risk of complications. This study will test whether patients with mild acute pancreatitis can be safely sent home with close follow-up (telephone calls on days 1, 2, and 3 after discharge and a clinic visit on day 4) instead of staying in hospital. Patients will be randomly assigned to either home management or standard hospitalization. We will compare the rate of treatment failure at 30 days between the two groups. We expect that home management will be as safe as hospitalization, while being more convenient for patients and less costly for the health system.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older Diagnosis of acute pancreatitis based on at least two of three revised Atlanta (2012) criteria: characteristic abdominal pain; serum lipase or amylase ≥3× upper limit of normal; or characteristic imaging findings Classification as mild acute pancreatitis: SIRS score = 0 and HAPS score = 0 at emergency department presentation Ability to tolerate oral intake at the time of randomisation Provision of written informed consent Presence of a competent caregiver at home Residence within 30-45 minutes' travel time from the hospital Ability to communicate by telephone

Disqualifiers

Pregnancy or breastfeeding Inability to maintain oral intake for reasons unrelated to acute pancreatitis Acute pancreatitis attributable to tumour, post-ERCP intervention, or abdominal trauma Concurrent choledocholithiasis with or without cholangitis Chronic pancreatitis or history of recurrent acute pancreatitis (≥2 prior episodes) ASA physical status classification ≥ 3 Clinical or radiological features suggesting moderately severe or severe acute pancreatitis Alcohol withdrawal syndrome No competent caregiver at home Residence more than 30-45 minutes from the hospital Inability to communicate by telephone or equivalent means

Trial design

Design model

Parallel

Treatments tested in this trial

  • Outpatient Management (Group A)

    Other intervention

    Early discharge from the emergency department after 4-6 hours of observation, with structured teleconsultation follow-up on Days 1, 2, and 3, in-person review on Day 4, unrestricted emergency department access, and 30-day outcome assessment.

  • Standard Inpatient Management (Group B)

    Other intervention

    Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Outpatient Management (Group A)Experimental treatment 1 intervention
Group B: Standard Inpatient Management (Group B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Failure Rate at 30 Days

Proportion of patients experiencing at least one of the following: food intolerance (\<50% of a standard meal), persistent nausea or vomiting refractory to antiemetics, uncontrolled pain requiring parenteral analgesia or emergency attendance, new-onset SIRS or HAPS deterioration, or (Group A only) any unplanned hospital admission.

Time frame
30 days from randomisation

Secondary outcomes

1

Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS)

Recurrence of abdominal pain during the 30-day follow-up period, assessed at each contact point (teleconsultation Days 1, 2, 3; clinic visit Day 4; final visit Day 30) using the Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst imaginable pain). Recurrence is defined as any new episode of abdominal pain scoring ≥4/10 after an initial pain-free interval following discharge or hospital admission.

Time frame
30 days
2

SIRS score at 48 hours

Time frame
48 hours
3

Organ failure Assessed by the Modified Marshall Scoring System

Rate of organ failure occurring within 30 days of randomisation, assessed using the Modified Marshall Scoring System. Organ failure is defined as a score of ≥2 in any of the three organ systems evaluated: respiratory (PaO₂/FiO₂ ratio), renal (serum creatinine), and cardiovascular (systolic blood pressure). Transient organ failure (resolving within 48 hours) and persistent organ failure (lasting \>48 hours) will be recorded separately.

Time frame
30 days
4

Unplanned hospital readmission

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Traumatology and Major Burns, Ben Arous

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: