Outpatient Versus Inpatient Management of Mild Acute Pancreatitis

Официальное название

Outpatient Versus Inpatient Management of Mild Acute Pancreatitis: A Randomised Controlled Non-Inferiority Trial

Обзор

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.

Подробное описание

Acute pancreatitis (AP) is one of the most common gastrointestinal causes of emergency hospital admission worldwide. Approximately 80% of cases are classified as mild according to the revised Atlanta Classification (2012) and resolve without organ failure or local complications within three to five days. Despite this favorable prognosis, current practice mandates universal inpatient admission. Only two small studies have explored outpatient management of mild AP, reporting treatment failure rates of 4-12% in the ambulatory arm; however, neither was prospectively randomized nor adequately powered for non-inferiority.

This trial is a prospective, single-center, open-label, two-arm, parallel-group, randomized controlled non-inferiority trial. Patients presenting with mild AP, confirmed by at least two revised Atlanta (2012) criteria and classified as mild by a SIRS score of 0 and a Harmless Acute Pancreatitis Score (HAPS) of 0, will be randomly allocated in a 1:1 ratio to outpatient management (Group A) or standard inpatient care (Group B). Randomization will use a table of random numbers with a block size of four. Group A patients will receive an initial 4-6 hour supervised observation period in the emergency department, followed by daily teleconsultation on days 1-3 and an in-person clinic visit on day 4. Group B patients will be admitted to hospital per standard institutional protocol. All patients will receive IAP/APA-compliant supportive care and a final 30-day outcome assessment. The primary endpoint is the 30-day treatment failure rate. Non-inferiority will be declared if the upper bound of the one-sided 95% confidence interval for the between-group difference does not exceed 10%.

Вмешательства

• Другое Outpatient Management (Group A)
  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.
• Другое Standard Inpatient Management (Group B)
  Conventional ward admission with daily monitoring, intravenous supportive care, and discharge based on clinical improvement.

Первичные конечные точки

• Treatment Failure Rate at 30 Days [Срок оценки: 30 days from randomisation]

Вторичные конечные точки (6)

• Recurrence of abdominal pain Assessed by Numeric Rating Scale (NRS) [Срок оценки: 30 days]
• SIRS score at 48 hours [Срок оценки: 48 hours]
• Organ failure Assessed by the Modified Marshall Scoring System [Срок оценки: 30 days]
• Unplanned hospital readmission [Срок оценки: 30 days]
• ICU admission rate [Срок оценки: 30 days]
• Patient satisfaction Assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) [Срок оценки: 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• Traumatology and great burns center — Ben Arous

Публикации

• 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 32233793
• 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 24054878
• 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 19245846
• 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 23100216

Идентификаторы

NCT: NCT07643961 · CTGBA/EC/2025/07-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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