NCT07643961

Brief Summary

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.

Trial Health

63
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Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

8 months

First QC Date

June 8, 2026

Last Update Submit

June 10, 2026

Conditions

Acute Pancreatitis (AP)Biliary Pancreatitis

Keywords

acute pancreatitisoutpatientambulatorynon-inferiorityrandomised controlled trialHAPSSIRS

Outcome Measures

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.

    30 days from randomisation

Secondary Outcomes (6)

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

    30 days

  • SIRS score at 48 hours

    48 hours

  • Organ failure Assessed by the Modified Marshall Scoring System

    30 days

  • Unplanned hospital readmission

    30 days

  • ICU admission rate

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Outpatient Management (Group A)

EXPERIMENTAL

Patients receive a 4-6 hour supervised observation in the emergency department, then are discharged with structured ambulatory follow-up: daily teleconsultation on Days 1, 2, and 3; in-person clinic visit with blood sampling on Day 4; open-access emergency readmission at any time; and a 30-day final consultation. All patients receive IAP/APA-compliant supportive care.

Other: Outpatient Management (Group A)

Standard Inpatient Management (Group B)

ACTIVE COMPARATOR

Patients are admitted to the gastroenterology or surgical ward for conventional inpatient care with daily clinical and biological monitoring, intravenous fluids, analgesia, antiemetics, and early oral refeeding per IAP/APA guidelines. Discharge is determined by clinical improvement and full oral diet tolerance. A 30-day follow-up consultation is arranged at discharge.

Other: Standard Inpatient Management (Group B)

Interventions

Outpatient Management (Group A)OTHER

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.

Outpatient Management (Group A)
Standard Inpatient Management (Group B)OTHER

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

Standard Inpatient Management (Group B)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Traumatology and great burns center

Ben Arous, Tunisia, 2074, Tunisia

Location

Related Publications (4)

  • Nardiello C, Morty RE. World No Tobacco Day 2020. Am J Physiol Lung Cell Mol Physiol. 2020 May 1;318(5):L1010-L1015. doi: 10.1152/ajplung.00110.2020. Epub 2020 Apr 1. No abstract available.

    PMID: 32233793RESULT

  • Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

    PMID: 24054878RESULT

  • Lankisch PG, Weber-Dany B, Hebel K, Maisonneuve P, Lowenfels AB. The harmless acute pancreatitis score: a clinical algorithm for rapid initial stratification of nonsevere disease. Clin Gastroenterol Hepatol. 2009 Jun;7(6):702-5; quiz 607. doi: 10.1016/j.cgh.2009.02.020. Epub 2009 Feb 24.

    PMID: 19245846RESULT

  • Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.

    PMID: 23100216RESULT

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Central Study Contacts

Imen Ben Ismail, M.D

CONTACT

+21696121434imen.benismail@fmt.utm.tn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor in visceral and digestive surgery

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations

TU(1)