Consorci Sanitari del Garraf
Sant Pere de Ribes, Barcelona, 08810, Spain
NCT Number: NCT03829085
Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.
The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.
Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.
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Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Sant Pere de Ribes, Barcelona, 08810, Spain
This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.
The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
Time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Days
Time frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
Time frame: 2-3 days approximately since the first day of hospital admission
Days
Time frame: 2-7 days approximately during hospital admission and during the follow up
The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals
Time frame: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Elevation amylase or lipase level after oral refeeding
Time frame: 1 month
Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis
Time frame: During hospital stay (up to 1 day)
Mortality
Time frame: 2 month
The rate of patients received operation for pancreatitis debridement
Consorci Sanitari del Garraf
Other
Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis
Acronym: PADI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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