Non-inferiority Comparative Clinical Trial Between Early Oral Refeeding Versus Usual Oral Refeeding in Mild Acute Pancreatitis Patients

BACKGROUND Acute pancreatitis (AP) is an inflammatory pancreatic process, presents different severity degrees [1]. Over the last two decades, there has been a paradigm shift in the management, from surgical to "step up" approach using percutaneous or endoscopic catheter drainage followed by minimally invasive necrosectomy [2]. As no curative therapy is currently available for AP, early treatment consists of supportive care which includes adequate fluid resuscitation, pain management and enteral nutrition [3]. Pancreatic rest by Nil Per Oral (NPO) strategy was considered necessary in AP till abdominal pain get resolved and the levels of pancreatic and inflammatory markers decrease [4]. This trend has changed, now it is clear that the early oral refeeding for PA mild does not only provide adequate caloric intake, it may also improve clinical outcomes. It has been hypothesized that the combination of disturbed intestinal motility, microbial overgrowth and increased permeability of the gut can lead to bacterial translocation, thus causing infection of pancreatic necrosis [5,6].

The oral refeeding (OR) may reduce translocation by stimulating intestinal motility, reducing bacterial overgrowth and thereby maintaining mucosal gut integrity [7,8]. Also decrease infection complications, organ failure and mortality as compared with routine total parenteral nutrition [9,10]. In patients with (predicted) mild pancreatitis, numerous studies concluded that a normal oral diet can be resumed once the pain is decreasing [11-13], However, it remains unclear what the optimal time to do it is. There is still no consensus about the definition of "early" refeeding.

The aim of the present study is to compare the onset of oral feeding in the first 24 hours after hospital admission and determine if this influences the recurrence of pain or alters the blood levels of pancreatic enzymes, compared to usual oral refeeding in patients with mild acute pancreatitis.

METHODS

Patients This Randomized controlled trial was carried out between September 2018 and June 2019, prior authorization from the ethics committee in health research.